Tuesday, October 23, 2018
Bulletin

ONCOdianova: The future of tumor tissue biomarkers

New antibodies for the detection of immune-checkpoint-proteins in tumor tissues support the development of novel therapeutic strategies.

Hamburg, August 2018. New immunotherapies give rise to hope for a breakthrough in the treatment of cancer. Cancer cells use immune-checkpoint-proteins to protect themselves against the attack of the immune system. Over the last few years, several immunotherapy-medication, which inhibit checkpoint-proteins, have been approved. An inhibition of those checkpoints leads to a strengthened body’s own defense against the tumor.

The ONCOdianova GmbH (www.oncodianova.com), a newly founded Biotechnology Company from Hamburg, focuses on the specific analysis of immune-checkpoint-proteins in tumor tissues using antibodies. ONCOdianova (www.oncodianova.com) has the vision to provide the best primary antibodies for the detection of immune-checkpoint-marker in the tumor tissue. The aim: To support the development of new cancer medication at the best.

According to the cancer information service experts expect around 493.600 new cases of cancer in Germany alone in 2018[1]. For the development of suitable therapies a differentiating analysis of the endogenous processes is decisive. ONCOdianova knows this and has set up a future-oriented development concept for antibodies in the field of immuno-oncology.

 

 

Antibodies against Checkpoint-Marker enable differentiated analyses of formalin-fixed tumor tissues

 

The use of antibodies in tissue-based studies, apart from the detection of the marker, has another great advantage: It is possible to examine which cells are expressing the marker within the tumor or tumor microenvironment in a morphological context. Clone TG1 is the first monoclonal antibody for the immunohistochemically detection of the important checkpoint-protein TIGIT, in routine formalin-fixed, paraffin-embedded (FFPE) tumor tissue. TG1 enables to identify TIGIT-proteins in the tumor “microenvironment“ and detects invading immune cells, so-called tumor-infiltrating T-cells. Examination of human tissue samples using TG1 can provide a valuable contribution to the clinical research community and tissue diagnostic, since potential medical-approaches can be better tailored to the TIGIT-mediated Tumor-immune-checkpoint.

 

 

The idea of ONCOdianova

 

“The idea behind our company ONCOdianova is to allow the best possible detection of Checkpoint biomarker in the tumor tissue. Our goal is to offer the best antibodies for the combined use in immunohistochemical panels”, explains ONCOdianova CEO Jürgen Frerichs. The first product, anti-TIGIT clone TG1, was presented at the annual meeting of the American Association for Cancer Research (AACR) in the USA in April 2018 as well as in recent studies about TG1 by teams of the University Hospital Hamburg-Eppendorf und the University of Colorado/Denver.

 

 

The future for ONCOdianova

 

“We believe that new antibodies for the immunohistochemical evaluation of tumors are essential for the development of optimal diagnostic algorithms”, says Jürgen Frerichs. The Biotech-Company focus strongly on the highly complex “TIGIT-axis” which is used for interaction between various immune-checkpoint-proteins and so allows the communication between tumor and immune system. Next to the development of further TIGIT-antibody-clones, ONCOdianova also concentrates on other marker for the TIGIT-axis such as CD155, CD226, CD112 and CD112R. “We see a great diagnostic potential and believe that immunohistochemical studies of immune-checkpoint markers in tumor tissues continue to gain importance. Future medication will be adapted to patients individual needs based on these studies and could provide optimal medical treatment.”, explains Frerichs.

 

The homepage ONCOdianova.com shows the latest news of the development, the project progress and further background information.

[1] https://www.krebsinformationsdienst.de/grundlagen/krebsstatistiken.php

Roche announces global availability of blood-based genomic profiling test, FoundationOne Liquid

  • Liquid biopsy test can identify 70 of the most commonly mutated genes in solid tumours, as well as microsatellite instability
  • Many cancer patients have insufficient or inadequate tissue for genomic testing and so may benefit from FoundationOne Liquid
  • FoundationOne Liquid joins FoundationOne CDx to deliver a complementary portfolio which provides insights to personalise a patient’s treatment plan

Basel, 24 September 2018 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the global availability of FoundationOne®Liquid, a liquid biopsy test. FoundationOne Liquid can identify circulating tumour DNA in the blood of people living with cancer and can identify 70 of the most commonly mutated genes in solid tumours, including microsatellite instability, a genomic signature which may help inform cancer immunotherapy based treatment decisions. [1,2] From a single blood sample, the liquid biopsy offers a quick and convenient option for some patients with solid tumours. [3]

FoundationOne Liquid meets a compelling need for comprehensive genomic profiling for people who have insufficient or inadequate tissue, including those with advanced non-small cell lung cancer, where an estimated 15% of patients are not eligible for tissue biopsy and approximately 10% have a biopsy size that is insufficient to evaluate. [4-6] FoundationOne Liquid complements FoundationOne CDx, a tissue-based genomic profiling test launched in the US earlier this year, to deliver a portfolio of comprehensive genomic profiling services for healthcare professionals.
“Cancer is a disease of the genome and genomic profiling of every patient’s tumour at the start of their treatment journey will provide transformative outcomes for patients,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “At Roche, we believe the use of innovative profiling technologies like FoundationOne Liquid and FoundationOne CDx will improve access to targeted cancer treatments for patients and enrich the future development of targeted medicines.”
About FoundationOne Liquid

FoundationOne Liquid is a liquid biopsy circulating tumour DNA (ctDNA) test that complements

FoundationOne CDx, a tissue-based test. The blood sample is sent to a Foundation Medicine lab where   the test is performed using next generation sequencing to analyse the four main classes of genomic alterations as well as microsatellite instability, an indicator that may help inform immunotherapy treatment decisions using ctDNA isolated from plasma derived from peripheral whole blood.
About FoundationOne CDx

FoundationOne CDx is based on the first US Food and Drug Administration-approved broad companion diagnostic assay to assess the four main classes of genomic alterations and identify patients with advanced cancer who are likely to respond to targeted therapies based on their individual genomic profile. The tissue sample is sent to a Foundation Medicine lab where the test is performed using next generation sequencing to analyse the four main classes of genomic alterations, as well as microsatellite instability and tumour mutational burden, using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumour tissue specimens. The test has been validated with 2,100 clinical samples and 4,200 analytical samples. [7] FoundationOne CDx is intended to be used by clinicians as decision-making support in consideration of a patient’s genomic profile for therapy selection and patient management according to professional guidelines in oncology for cancer patients.
 

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer. The company, a member of the Roche Group, offers a full suite of comprehensive genomic profiling tests to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer.

For more information, please visit http://www.foundationmedicine.com or follow Foundation Medicine on Twitter (@FoundationMedicineATCG).
About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the tenth consecutive year, Roche has been recognised as the most sustainable company in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.

References

[1] Foundation Medicine. FoundationOne Liquid Technical Specifications [Internet: accessed September 2018]. Available from: https://www.foundationmedicine.com/genomic-testing/foundation-one-liquid.

[2] Dudley JC, et al. Microsatellite Instability as a Biomarker for PD-1 Blockade. Clin Cancer Res. 2016; 22:813-20.

[3] Clark TA, et al. Analytical Validation of a Hybrid Capture-Based Next-Generation Sequencing Clinical Assay for Genomic Profiling of Cell-Free Circulating Tumor DNA. J Mol Diagn. 2018; S1525-1578(17)30527-5 [Epub ahead of print].

[4] Rafael OC, et al. Molecular Testing in Lung Cancer: Fine-Needle Aspiration Specimen Adequacy and Test Prioritization Prior to the CAP=IASLC=AMP Molecular Testing Guideline Publication. Cancer Cytopathology. 2014; 122(6):454-458.

[5] Douillard JY, et al. Gefitinib Treatment in EGFR Mutated Caucasian NSCLC. J Thorac Oncol. 2014; 9:1345-1353.

[6] Kim ES, et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet. 2008; 372:1809-18.

[7] Foundation Medicine website: FoundationOne CDx – “Go Beyond FoundationOne®” [Internet: accessed September 2018]. Available from: https://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.

Roche Group Media Relations

Phone: +41 61 688 8888 / e-mail: media.relations@roche-global.com
– Nicolas Dunant (Head)

– Patrick Barth

– Ulrike Engels-Lange

– Simone Oeschger

– Anja von Treskow

Positive phase III results for Roche’s Hemlibra for haemophilia A without factor VIII inhibitors published in New England Journal of Medicine

  • Hemlibra prophylaxis significantly reduced bleeds compared to no prophylaxis
  • Hemlibra is the first medicine to demonstrate superior efficacy to prior factor VIII prophylaxis based on a statistically significant reduction in treated bleeds in an intra-patient comparison
  • Hemlibra is currently under Priority Review by the FDA for people with haemophilia A without factor VIII inhibitors

Basel, 30 August 2018 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that pivotal data from the phase III HAVEN 3 study, which evaluated Hemlibra® (emicizumab) prophylaxis administered every week or every two weeks in adults and adolescents aged 12 years or older with haemophilia A without factor VIII inhibitors, were published in the 30 August 2018 issue of the New England Journal of Medicine (NEJM).

“In the HAVEN 3 study, Hemlibra showed a significant and clinically meaningful reduction in bleeds in people with haemophilia A without factor VIII inhibitors, while offering multiple subcutaneous dosing options,” said Johnny Mahlangu, Faculty of Health Sciences, University of the Witwatersrand and NHLS, Johannesburg, South Africa. “The publication of these results in the New England Journal of Medicine represents a major advance for haemophilia research and reinforces the potential of Hemlibra to change the standard of care for people with haemophilia A.”

“Current prophylactic treatment options for people with haemophilia A can require frequent intravenous infusions, and despite treatment, many continue to have bleeds that can lead to long-term joint damage,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Given the challenges many people face managing their haemophilia, we believe Hemlibra could make a meaningful difference, and we are working with health authorities to hopefully make this treatment available to people with haemophilia A without factor VIII inhibitors as soon as possible.”

Data from the HAVEN 3 study showed that Hemlibra prophylaxis administered subcutaneously every week or every two weeks significantly reduced treated bleeds by 96% (rate ratio [RR]=0.04; p<0.0001) and 97% (RR= 0.03; p<0.0001), respectively, compared to no prophylaxis. Results also showed that 55.6% (95% CI: 38.1; 72.1) of people treated with Hemlibra every week and 60% (95% CI: 42.1; 76.1) of people treated with Hemlibra every two weeks experienced zero treated bleeds, compared to 0% (95% CI: 0.0; 18.5) of people treated with no prophylaxis. In an intra-patient comparison of people who previously received factor VIII prophylaxis in a prospective non-interventional study and switched to Hemlibra prophylaxis, Hemlibra demonstrated a statistically significant reduction of 68% (RR=0.32; p<0.0001) in treated bleeds, making it the first medicine to show superior efficacy to prior factor VIII prophylaxis treatment, the current standard of care. There were no unexpected or serious adverse events (AEs) related to Hemlibra in the HAVEN 3 study, and the most common AEs were consistent with previous studies. The most common AEs occurring in 5% or more of people were injection site reactions, joint pain (arthralgia), common cold symptoms (nasopharyngitis), headache, upper respiratory tract infection and influenza.
Earlier this year, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation and Priority Review to Hemlibra for people with haemophilia A without factor VIII inhibitors based on data from the HAVEN 3 study. The FDA is expected to make a decision on approval by 4 October 2018. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat a serious condition with preliminary evidence that indicates they may demonstrate substantial improvement over existing therapies. Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a serious disease. In addition, the company’s Marketing Authorisation Application (MAA) variation of Hemlibra for haemophilia A without factor VIII inhibitors is under review by the European Medicines Agency (EMA). Submissions to other regulatory authorities around the world are ongoing.
 

About HAVEN 3 (NCT02847637)

HAVEN 3 is a randomised, multicentre, open-label, phase III study evaluating the efficacy, safety and pharmacokinetics of Hemlibra prophylaxis versus no prophylaxis (episodic/on-demand factor VIII treatment) in people with haemophilia A without factor VIII inhibitors. The study included 152 patients with haemophilia A (12 years of age or older) who were previously treated with factor VIII therapy either on-demand or for prophylaxis. Patients previously treated with on-demand factor VIII were randomised in a 2:2:1 fashion to receive subcutaneous Hemlibra prophylaxis at 3 mg/kg/wk for 4 weeks, followed by 1.5 mg/kg/wk for at least 24 weeks (Arm A), subcutaneous Hemlibra prophylaxis at 3 mg/kg/wk for 4 weeks, followed by 3 mg/kg/2wks (Arm B) for at least 24 weeks or no prophylaxis (Arm C) for at least 24 weeks. Patients previously treated with factor VIII prophylaxis received subcutaneous Hemlibra prophylaxis at 3 mg/kg/wk for 4 weeks, followed by 1.5 mg/kg/wk until the end of study (Arm D). Episodic treatment of breakthrough bleeds with factor VIII therapy was allowed per protocol.

The phase III HAVEN 3 study in people with haemophilia A without factor VIII inhibitors met its primary         endpoint and key secondary endpoints. Data from the study showed:

  • Hemlibra prophylaxis every week or every two weeks resulted in a 96% (RR=0.04; p<0.0001) and 97% (RR=0.03; p<0.0001) reduction in treated bleeds, respectively, compared to no prophylaxis.
  • 55.6% (95% CI: 38.1, 72.1) of people treated with Hemlibra every week and 60% (95% CI: 42.1, 76.1) of people treated with Hemlibra every two weeks experienced zero treated bleeds, compared to 0% (95% CI: 0.0; 18.5) of people treated with no prophylaxis.
  • 91.7% (95% CI: 77.5, 98.2) of people treated with Hemlibra prophylaxis every week and 94.3% (95% CI: 80.8, 99.3) of people treated with Hemlibra prophylaxis every two weeks experienced three or fewer treated bleeds, compared to 5.6% (95% CI: 0.1, 27.3) of people treated with no prophylaxis.
  • Hemlibra prophylaxis every week or every two weeks resulted in a 95% (RR=0.05; p<0.0001) and 95% (RR=0.05; p<0.0001) reduction in treated target-joint bleeds, respectively, compared to no prophylaxis.
  • Hemlibra prophylaxis every week or every two weeks resulted in a 95% (RR=0.05; p<0.0001) and 94% (RR=0.06; p<0.0001) reduction in all bleeds, respectively, compared to no prophylaxis.
  • Hemlibra prophylaxis every week demonstrated a statistically significant reduction of 68% (RR=0.32; p<0.0001) in treated bleeds compared to prior factor VIII prophylaxis based on an intra-patient comparison of people who were previously enrolled in a prospective non-interventional study.
  • There were no unexpected or serious AEs related to Hemlibra, and the most common AEs were consistent with previous studies. No thrombotic events or cases of thrombotic microangiopathy were observed. The most common AEs occurring in 5% or more of people were injection site reactions, joint pain (arthralgia), common cold symptoms (nasopharyngitis), headache, upper respiratory tract infection and influenza.
  • There were no unexpected or serious AEs related to Hemlibra, and the most common AEs were consistent with previous studies. No thrombotic events or cases of thrombotic microangiopathy were observed. The most common AEs occurring in 5% or more of people were injection site reactions, joint pain (arthralgia), common cold symptoms (nasopharyngitis), headache, upper respiratory tract infection and influenza.

About Hemlibra® (emicizumab)

Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins required to activate the natural coagulation cascade and restore the blood clotting process for people with haemophilia A. Hemlibra is a prophylactic (preventative) treatment that can be administered by an injection of a ready-to-use solution under the skin (subcutaneously) once-weekly. The clinical development programme is assessing the safety and efficacy of Hemlibra and its potential to help overcome current clinical challenges: the short-lasting effects of existing treatments, the development of factor VIII inhibitors and the need for frequent venous access. Hemlibra was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed globally by Chugai, Roche and Genentech. It is marketed in the United States by Genentech as Hemlibra (emicizumab-kxwh) for people with haemophilia A with factor VIII inhibitors, with kxwh as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the US Food and Drug Administration.

About haemophilia A

Haemophilia A is an inherited, serious disorder in which a person’s blood does not clot properly, leading to uncontrolled and often spontaneous bleeding. Haemophilia A affects around 320,000 people worldwide, [1,2] approximately 50-60% of whom have a severe form of the disorder. [3] People with haemophilia A either lack or do not have enough of a clotting protein called factor VIII. In a healthy person, when a bleed occurs, factor VIII brings together the clotting factors IXa and X, which is a critical step in the formation of a blood clot to help stop bleeding. Depending on the severity of their disorder, people with haemophilia A can bleed frequently, especially into their joints or muscles.[1] These bleeds can present a significant health concern as they often cause pain and can lead to chronic swelling, deformity, reduced mobility, and long-term joint damage. [4] A serious complication of treatment is the development of inhibitors to factor VIII replacement therapies. [5] Inhibitors are antibodies developed by the body’s immune system that bind to and block the efficacy of replacement factor VIII,[6] making it difficult, if not impossible to obtain a level of factor VIII sufficient to control bleeding.
About Roche in haematology

For more than 20 years, Roche has been developing medicines that redefine treatment in haematology. Today, we are investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. In addition to approved medicines MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), and Venclexta®/Venclyxto(TM) (venetoclax) in collaboration with AbbVie, Roche’s pipeline of investigational haematology medicines includes Tecentriq® (atezolizumab), an anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596) and a small molecule antagonist of MDM2 (idasanutlin/RG7388). Roche’s dedication to developing novel molecules in haematology expands beyond malignancy, with the development of Hemlibra® (emicizumab), a bispecific monoclonal antibody for the treatment of haemophilia A.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.

References

[1] WFH. Guidelines for the management of haemophilia. 2012 [Internet; cited 2018 July]. Available from:

http://www1.wfh.org/publications/files/pdf-1472.pdf

[2] Berntorp E, Shapiro AD. Modern haemophilia care. The Lancet 2012; 370:1447-1456.

[3] Marder VJ, et al. Hemostasis and Thrombosis. Basic Principles and Clinical Practice. 6th Edition, 2013. Milwakee, Wisconsin. Lippincott Williams and Wilkin.

[4] Franchini M, Mannucci PM. Haemophilia A in the third millennium. Blood Rev 2013; 179-84.

[5] Gomez K, et al. Key issues in inhibitor management in patients with haemophilia. Blood Transfus. 2014; 12:s319-s329.

[6] Whelan, SF, et al. Distinct characteristics of antibody responses against factor VIII in healthy individuals and in different cohorts of haemophilia A patients. Blood 2013; 121:1039-48.

Roche Group Media Relations

Phone: +41 61 688 8888 / e-mail: media.relations@roche-global.com
– Nicolas Dunant (Head)

– Patrick Barth

– Ulrike Engels-Lange

– Simone Oeschger

– Anja von Treskow

 

 

 

 

 

 

PRIME designation granted by European Medicines Agency for RG6042 for treatment of Huntington’s disease

  • European Medicines Agency PRIME (PRIority MEdicines) status is granted to medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options
  • RG6042 has the potential to be the first therapy targeting the underlying cause of Huntington’s disease, a fatal neurodegenerative rare disease
  • Third PRIME designation for a Roche medicine 

Basel, 3 August 2018 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation for the company’s investigational medicine RG6042 (formerly known as IONIS-HTTRx) for the treatment of people with Huntington’s disease (HD). RG6042 has demonstrated its ability to reduce the toxic mutant huntingtin protein (mHTT), which is believed to be the underlying cause of HD, in a Phase I/IIa study.[1] PRIME is a designation implemented by the EMA to support data generation and development plans for promising medicines, providing a pathway for accelerated evaluation by the agency, and thus potentially enable them to reach patients earlier.[2]

“We are very pleased that the European Medicines Agency has granted PRIME designation for RG6042, as there is an urgent medical need to find treatment options for families affected by Huntington’s disease,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Preliminary data on RG6042 were the first to show that levels of toxic mutant huntingtin protein can be lowered in adults with Huntington’s disease, and we are working closely with the EMA and other health authorities to initiate a global phase III study as soon as possible.”

PRIME designation for RG6042 is primarily based on the data from an exploratory Phase I/IIa trial of RG6042 that demonstrated a significant reduction in mHTT, which breaks down the nerve cells in the brain.[1] The study demonstrated a mean 40% (up to 60%) reduction of the specific HD protein in the cerebrospinal fluid (CSF) of adult patients treated with RG6042 for three months at the two highest doses. Furthermore, levels of mHTT measured in the CSF were still declining in the majority of treated patients (~70%) as of the last measurement in the study.[3] RG6042 was well tolerated in this short initial study.[1] These data were shared at the CHDI 13th Annual HD Therapeutics Conference in March 2018,[3] and updated results were presented at the American Academy of Neurology (AAN) Annual Meeting in April 2018.[4]

Roche will initiate a pivotal phase III study to evaluate RG6042 in a larger patient population to further characterise the safety profile and determine if it can slow the progression of HD in adults.

About RG6042

RG6042 is a second-generation modified antisense oligonucleotide (ASO) designed to reduce the production and levels of mHTT protein by targeting human HTT mRNA.[5]RG6042 is the result of a comprehensive drug discovery programme between Roche and Ionis Pharmaceuticals focused on optimising the potency, specificity and tolerability of an ASO targeting human HTT mRNA. RG6042 is the most advanced compound in clinical development to target toxic mutant huntingtin protein (mHTT), which is believed to be the underlying cause of HD. Treatment with RG6042 has the potential to slow or stop disease progression in all people with HD.[1]

About Huntington’s disease

Huntington’s disease is a rare genetic, progressive condition that causes the nerve cells in the brain to break down, which severely affects a person’s everyday functions such as mobility and thinking.[6] It has a devastating impact on people living with the disease, and the hereditary nature of HD means it profoundly affects entire families.[6] As the disease progresses, people with HD may develop personality changes, difficulty walking and swallowing, as well as having a significant cognitive impact.[6] Survival ranges from approximately 10-20 years following motor onset of the disease.[6]

There is no known cure for HD and no approved therapies that treat the underlying cause. The estimates for the number of people affected by Huntington’s vary between geographic regions. Huntington’s disease is the most common monogenic neurological disorder in the developed world, with an estimated prevalence of ~3.5-7/100,000 in North America, Western Europe, and Australia.[7]

About Roche in neuroscience

Neuroscience is a major focus of research and development at Roche. The company’s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease, Huntington’s disease and autism spectrum disorder.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines.

Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.

References

[1] Ionis Pharmaceuticals. 2018. Press release: IONIS-HTT Rx (RG6042) top-line data demonstrate significant reductions of disease-causing mutant Huntingtin protein in people with Huntington’s disease. [Internet; cited 2018 July]. Available from: http://ir.ionispharma.com/node/23401/pdf

[2] European Medicines Agency. PRIME Designation. [Internet; cited 2018 July]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/

[3] CHDI 13th Annual HD Therapeutics Conference 2018. Press Release: Ionis Pharmaceuticals Licenses IONIS-HTT Rx to Partner Following Successful Phase 1/2a Study in Patients with Huntington’s Disease. [Internet; cited 2018 July]. Available from: https://chdifoundation.org/ionis-pharmaceuticals-licenses-ionis-htt-rx-to-partner-following-successful-phase-12a-study-in-patients-with-huntingtons-disease/.  (Data on file)

[4] Ionis Pharmaceuticals. 2018. Press release: New Data from IONIS-HTT Rx Phase 1/2 Study Demonstrates Correlation Between Reduction of Disease-causing Protein and Improvement in Clinical Measures of Huntington’s Disease. [Internet; cited 2018 July]. Available from: http://ir.ionispharma.com/node/23661/pdf.
[5] Leavitt B, Tabrizi S, Kordasiewicz H et al. Discovery and early clinical development of ISIS-HTTRx, the first HTT-lowering drug to be tested in patients with Huntington’s disease (PL01.002). Neurology 2016;86(Suppl. 16):PL01.002. [Internet; cited 2018 July]. Available from: http://n.neurology.org/content/86/16_Supplement/PL01.002.
[6] NHS Choices. Huntington’s disease: Overview. [Internet; cited 2018 July]. Available from: https://www.nhs.uk/conditions/huntingtons-disease/.
[7] Rawlins M, et al. The Prevalence of Huntington’s Disease. Neuroepidemiology 2016;46:144-153.

Roche Group Media Relations

Phone: +41 61 688 8888 / e-mail: media.relations@roche-global.com
– Nicolas Dunant (Head)

– Patrick Barth

– Ulrike Engels-Lange

– Simone Oeschger

– Anja von Treskow

 

Shri J P Nadda addresses 8th BRICS Health Ministers’ Meeting at Durban; highlights the achievements of India in the health sector

“India affirms strong support for TB cooperation plan in every aspect as agreed upon in the 6th BRICS Health Ministers’ meeting held in Delhi in 2016 and in the first High-Level Meeting of the UN General Assembly on Ending Tuberculosis.”This was stated by Shri J P Nadda, Union Minister of Health and Family Welfare during his address at the ‘8th BRICS Health Ministers’ Meeting at Durban, South Africa, today. Shri J P Nadda further said that to improve healthcare, there is a need for increasing accessibility of affordable, quality, effective and safe drugs, vaccines and diagnostics for TB patients. “I would like to state that India is
committed to eliminating TB by 2025,” the Union Health Minister further emphasized.

In his address, Shri Nadda said that India today is more firmly committed to achieving Universal Health Coverage (UHC) as articulated in its National Health Policy. “India has fast-tracked many initiatives aimed at achieving all the core tenets of Universal Health Coverage i.e, strengthening health systems, improving access to free medicines and diagnostics and reducing catastrophic healthcare spending,” he added. He stated that to translate the vision of UHC, Prime Minister of India,Shri Narendra Modi has recently launched an ambitious programme called ‘Ayushman Bharat’ i.e. Long Live India. “The programme rests on the twin pillars of Health and Wellness Centres for provision of comprehensive primary healthcare services and National Health Protection Mission for secondary and tertiary care that aims to cover around 100 million families,” Shri Nadda said.

Highlighting the accomplishments of India in the health sector, Shri Nadda stated that India’s achievement in
reducing the maternal mortality ratio (MMR) by 77%, from 556 per 100000 live births in 1990 to 130 per 100
000 live births in 2016 was commended by Regional Director, WHO SEARO.

“This achievement puts the country on track to achieve the Sustainable Development Goal (SDG) target of
MMR below 70 by 2030. I would like to mention schemes like Pradhan Mantri Surakshit Matritva Abhiyan,
allowing women access to antenatal check-ups, obstetric gynaecologists and to track high-risk pregnancies,
etc., and Janani Shishu Suraksha Karyakram,”Shri Nadda stated.

During his address, the Union Health Minister said that to reduce the burden of NCDs, India has already initiated universal screening for prevention and management of five common NCDs including hypertension, diabetes and three common cancers of oral cavity, breast and cervix at pan India level. “He further said that India has started a unique initiative called AMRIT Deendayal pharmacies, an acronym for ‘Affordable Medicines & Reliable Implants for Treatment’ – Centres that provide medicines for cancer & cardiovascular diseases and cardiac implants at significantly reduced prices. “We must, therefore, renew our resolve and commitment to fight NCDs together on the BRICS platform, through R &D and innovative strategies,” Shri Nadda said.

Shri Nadda further said that there is need to promote strategies for use of traditional or alternative forms of medicine, like Ayurveda in India and the Chinese traditional remedies.“It is important that within the framework of BRICS, we carry out not only an exchange of technologies and the development of joint ventures, but also the co-generation of knowledge because, only together can we solve the most significant health problems,” the Union Health Minister added while reiterating the need for enhanced cooperation

Cabinet approves establishment of Medical College, Salempur at Deoria, Uttar Pradesh

The Cabinet Committee on Economic Affairs chaired by Prime Minister Shri Narendra Modi has approved the
proposal of the State Government of Uttar Pradesh for establishment of new medical college at Deoria at a cost of Rs.250 crore under Phase-II of the Centrally Sponsored Scheme.

Under Phase-II of the Centrally Sponsored Scheme for establishment of new medical colleges attached with
existing District/Referral hospitals, the criteria for one medical in every three Parliamentary Constituencies and one Government medical college in each State was adopted. Accordingly, a requirement of 24 additional medical colleges including eight medical colleges in Uttar Pradesh has been approved.

Out of the eight identified Blocks in Uttar Pradesh, the Block-6 consists of (70) Ghosi, (71) Salempur and (72)
Ballia Parliamentary Constituencies. The State Government of Uttar Pradesh has recommended for
establishment of Medical Colleges, Salempur at Deoria by up-gradation of District Hospital, Deoria.
The State Government has informed that Salempur is part of District Deoria and Salempur Parliamentary
Constituency is partly covered under District Deoria. The District Hospital, Deoria is also suitable as it has
sufficient number of beds and other facilities including availability of land as per MCI norms for the establishment of medical college of all possible locations in the identified Block.

  • Late-breaking Phase II exploratory analysis of investigational crenezumab to show impact on amyloid beta oligomer levels in CSF
  • Two year open-label extension updates for investigational gantenerumab will include data on effects of higher doses in reducing amyloid PET load and long-term safety

Basel, 20 July 2018 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will present 16 new data presentations from across its Alzheimer’s disease (AD) pipeline at this year’s Alzheimer’s Association International Conference (AAIC) from 22-26 July in Chicago, Illinois. Roche’s AD pipeline includes two late stage investigational molecules, crenezumab and gantenerumab, which are both in Phase III clinical trials, and an anti-tau molecule in Phase II.

“The range of data that Roche is presenting at AAIC is a testament to our commitment to bring new treatments to help the many millions of people living with Alzheimer’s disease,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development.

In a late-breaking session, an exploratory analysis is being presented on crenezumab from the completed phase II BLAZE and ABBY clinical trials that will show the impact of crenezumab treatment over the whole trial duration on amyloid beta oligomer levels in cerebrospinal fluid (CSF) in people with mild to moderate AD. Baseline data from the CREAD 1 study in prodromal to mild AD will also be presented. Crenezumab is an investigational, monoclonal antibody designed to preferentially bind to and promote removal of oligomers, a form of amyloid beta.

Additionally, updates from open-label extension studies of gantenerumab, including data on the effects of higher doses of gantenerumab in reducing amyloid PET load at 24-months, as well as long-term safety data, will be presented. Data on the effects of low doses of gantenerumab on amyloid and tau biomarkers in cerebrospinal fluid will also be presented. Gantenerumab is an investigational, monoclonal antibody designed to bind to aggregated beta-Amyloid and remove amyloid beta plaques. Two recently initiated Phase III GRADUATE clinical studies are evaluating the safety and efficacy of gantenerumab for the treatment of early AD.

The full range of data from Roche’s Alzheimer’s clinical development program, including investigational medicines and diagnostics, being presented at AAIC include:

Investigational

Medicine

Abstract Title

Abstract Number (type), Presentation Date, Time

Crenezumab

LATE BREAKER: Target Engagement in an AD Trial: Crenezumab Lowers Abeta Oligomer Levels in CSF

Selkoe D (oral)

 

Session: DT-02-03 Developing Topics: Recent Developments in Biomarkers,

Wednesday, July 25, 20184:45-5:00 PM

Baseline characteristics from a phase 3 trial of crenezumab in prodromal to mild Alzheimer’s disease (CREAD) Lin H, et al.

Lin H (oral)

 

Session: 01-02 Clinical Prevention and Early Alzheimer’s Disease Trials, Sunday, July 22, 2018: 8:45 AM – 9:00 AM

Gantenerumab

The Effect of Low Doses of Gantenerumab on Amyloid and Tau Biomarkers in Cerebrospinal Fluid (CSF) in the Marguerite Road Study

Voyle N (oral)

 

Session: O1-09 Clinical: Clinical Investigations in Symptomatic AD Using Abeta Targeted Therapeutics, Sunday, July 22, 2018: 2:15 – 2:30 PM

24-Month Amyloid PET Results of the Gantenerumab High-Dose Open Label Extension Studies

Klein G (oral)

 

Session: O1-09 Clinical: Clinical Investigations in Symptomatic AD Using Abeta Targeted Therapeutics, Sunday, July 22, 2018: 2:30 – 2:45 PM

Update on the Safety and Tolerability of Gantenerumab in the Ongoing Open-Label Extension (OLE) of the Marguerite Road Study in Patients with Mild Alzheimer’s Disease (AD) after Approximately Two Years of Study Duration

Abi-Saab D (oral)

 

Session: O1-09 Clinical: Clinical Investigations in Symptomatic AD Using Abeta Targeted Therapeutics, Sunday, July 22, 2018: 2:45 – 3:00 PM

Update on the Safety and Tolerability of Gantenerumab in the Ongoing Open-Label Extension of the Scarlet Road Study in Patients with Prodromal Alzheimer’s Disease after Approximately 2 Years of Study Duration

Andjelkovic M (oral)

 

Session: O1-09 Clinical: Clinical Investigations in Symptomatic AD Using A-Beta Targeted Therapeutics, Sunday, July 22, 2018: 3:00 – 3:15 PM

 

CSF Biomarkers

LATE BREAKER: Detecting brain amyloid status using fully automated plasma Abeta biomarker assays

 

Hansson O (oral)

Session: DT-02-04 Developing Topics: Recent Developments in Biomarkers,

Wednesday, July 25, 20185:00-5:15 PM

Analysis of cerebrospinal fluid (CSF) biomarkers to predict risk of clinical decline and progression to dementia in patients with mild cognitive impairment and mild cognitive symptoms

Shaw LM (poster)
Session: P3-06 Diagnosis and Prognosis: Biomarkers (non-neuroimaging) Tuesday, July 24, 20189:30 AM – 4:15 PM, McCormick Place, Hall F1

Multicenter evaluation of the analytical characteristics of the Elecsys® Total-Tau cerebrospinal fluid (CSF) and Elecsys® Phospho-Tau (181P) CSF immunoassays

Kollmorgen G (poster)
Session: P1-07 Diagnosis and Prognosis: Biomarkers (non-neuroimaging) Sunday, July 22, 2018: 9:30 AM – 4:15 PM, McCormick Place, Hall F1

Technical validation and multicenter evaluation of the Elecsys® beta-Amyloid 1-40 prototype immunoassay for quantitation in cerebrospinal fluid (CSF)

Wiegers AK (poster)
Session: P1-07 Diagnosis and Prognosis: Biomarkers (non-neuroimaging) Sunday, July 22, 2018: 9:30 AM – 4:15 PM, McCormick Place, Hall F1

A Unified Pre-Analytical Protocol for Handling of CSF Samples before Analyses of AD Biomarker Levels

Hansson O (oral) 
Session: O2-09 Biomarkers: Methods and Quality, Monday, July 23, 2018: 2:00 PM – 3:30 PM

CSF biomarkers in the general population: associations with demographics and APOE genotype

Van Harten AC (oral)

 

02-04 Biomarkers: Longitudinal Changes: Monday, July 23, 3018: 9:00 AM – 9:15 AM,

Diagnostic performance of Elecsys® immunoassays for cerebrospinal fluid Alzheimer’s disease biomarkers in a non-academic multicentre memory clinic cohort: the ABIDE project

Willemse E (oral)
Session: O2-09 Biomarkers: Methods and Quality, Monday, July 23, 2018: 2:00 PM – 3:30 PM

 

PET Tau Tracers

Tau Burden Measured Using [18F]GTP1 Correlates with CSF Tau Phosphorylation at Sites T217 and T205 More Closely Than T181

Wildsmith K (oral)

 

Session: O3-14 Biomarkers: Novel Biomarkers in Cerebrospinal Fluid (CSF), Tuesday, July 24, 20184:30 PM – 4:45 PM

 

Baseline Tau Burden Measured By [18f]GTP1 Imaging Is Associated with Subsequent Cognitive Decline in Prodromal to Mild Alzheimer’s Disease

Teng E (poster)

 

Session: P4-17 Developing Topics, Wednesday, July 25, 20189:30 AM – 4:15 PM, McCormick Place, Hall F1

Non-molecule

P# 25259 Estimand in Early Alzheimer’s Disease: Progress Update from the International Alzheimer’s Disease Scientific Working Group (AD SWG) Substream.

Delmar P (poster)

 

Session:  P4-01 [Posters Wed] Therapeutics: Clinical, Wednesday, July 25, 20189:30 AM – 4:15 PM, Hall F1


About crenezumab
Crenezumab is an investigational, monoclonal antibody designed to preferentially bind to and promote removal of neurotoxic oligomers, a form of amyloid beta. Crenezumab has an antibody backbone (IgG4) designed to minimize the inflammatory response in the brain, which may result in a lower risk of MRI abnormalities. It is currently being studied in two phase III, two-year, randomized, double-blind, placebo-controlled, multicenter clinical trials (CREAD 1 and 2) in early AD.  Based on the learnings from two completed phase II trials, the CREAD studies are using higher doses of crenezumab and have enrolled people with early AD who have confirmed AD pathology. These studies are now fully enrolled.
Crenezumab is also being studied in a landmark Alzheimer’s Prevention Initiative (API) trial of cognitively healthy individuals in Colombia with an autosomal dominant mutation who are at risk to develop early-onset AD. Crenezumab is being developed by Roche and Genentech and was discovered by Swiss biotechnology company AC Immune SA.

About gantenerumab
Gantenerumab is an investigational, monoclonal antibody designed to bind to aggregated amyloid beta and remove amyloid beta plaques. It is being investigated in two phase III studies (GRADUATE 1 and 2) for the treatment of early AD. In completed phase III clinical studies, gantenerumab removed beta amyloid plaques, which have been shown to be toxic to the brain. Ongoing open-label extension studies have informed the design of the GRADUATE program. The new studies, which are enrolling people with early AD with confirmed AD brain pathology, include higher doses of gantenerumab. The target dose is achieved through a titration regimen to optimize safety. Gantenerumab is also being studied as part of the DIAN-TU trial, a worldwide clinical study evaluating multiple compounds in individuals at risk for or with a type of early-onset AD caused by a genetic mutation. Gantenerumab is being developed by Roche and Genentech and was identified and optimized by phage display technology in cooperation with MorphoSys AG, a Munich-based Biotech.

About Alzheimer’s disease
Alzheimer’s disease is a progressive, fatal disease of the brain that gradually destroys memory, thinking skills and problem solving and impairs daily functioning such as the ability to manage one’s own activities. Biological changes are believed to start decades before clinical symptoms of Alzheimer’s disease become evident. In the early stages (prodromal to mild dementia), people may have difficulty remembering things, but daily function may or may not be impaired. In the later stage of the disease, people increasingly become reliant on others for even simple day-to-day tasks. Dementia affects 44 million people worldwide with 7.7 million new cases each year, of which Alzheimer’s disease is the most common form. There is no cure for Alzheimer’s disease. Current treatments focus on alleviating symptoms and are unable to stop Alzheimer’s from progressing because they do not affect the disease’s underlying causes.

Hear from Rachelle Doody, Roche’s Global Head of Neurodegeneration, about our strength in both diagnosis and treatment.


About Roche in neuroscience
Neuroscience is a major focus of research and development at Roche. The company’s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease, Huntington’s disease and autism spectrum disorder.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche-global.com
– Nicolas Dunant (Head)
– Patrick Barth
– Ulrike Engels-Lange
– Simone Oeschger
– Anja von Treskow

20180720-Roche-MR_Alzheimers_AAIC_en

Basel, 20 July 2018 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today, that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Elecsys® beta-Amyloid (1-42) CSF and Elecsys® Phospho-Tau (181P) CSF. These in vitro diagnostic immunoassays are for the measurement of the beta-Amyloid (1-42) and Phospho-Tau concentrations in cerebrospinal fluid (CSF) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) or other causes of dementia.

Currently, the diagnosis of AD is largely based on clinical symptoms, including cognitive testing, with a significant number of patients diagnosed when their disease has already advanced. A diagnosis of AD based on cognitive measures alone is only correct in 70 – 80 percent of cases. Measuring biomarkers with CSF immunoassays, associated with AD pathology, increases certainty of a diagnosis of AD and can help to evaluate the progression of the disease. The Breakthrough Device Designations are for indication of use with Elecsys beta-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF in concordance with amyloid PET visual read result and risk of cognitive or functional decline. The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. This program is designed to expedite the development and review of these medical devices.

“We are excited about FDA’s recognition of the potential clinical benefit the Elecsys CSF assays can bring to clinicians, laboratories and their patients in diagnosing AD at an early stage,” said Roland Diggelmann, CEO of Roche Diagnostics. “Roche was one of the first companies to use biomarkers in clinical trials and we will continue to explore high-performing diagnostic and disease-monitoring solutions.”

About Elecsys® CSF immunoassays
Establishing the presence of degenerative diseases of the central nervous system is important when it comes to distinguishing age-related memory disorders from early-stage dementia. Deposits of beta-amyloid peptides (1-42) and neurofibrillary tangles in the brain are the two earliest changes associated with the development of Alzheimer’s disease and can be detected by different methods. Biomarkers in the cerebrospinal fluid (CSF) help clinicians detect Alzheimer’s disease, the most common form of dementia, from an earlier stage. Currently available for countries accepting the CE Mark*, the Elecsys beta-Amyloid (1-42) CSF, Elecsys Phospho-Tau (181p) CSF and Elecsys(R) Total-Tau CSF immunoassays are in vitro tests for the quantitative determination of concentrations of the beta-amyloid (1-42), phospholylated tau (181P) protein and total Tau protein in human cerebrospinal fluid. [1-3] The markers can be used alone or in combination. [1-3] The ElectroChemiLuminescence Immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. [1-3]
*
Local product availability may vary independently from CE Mark approval.

About Alzheimer’s disease
Alzheimer’s disease is a progressive, fatal disease of the brain that gradually destroys memory, thinking skills and problem solving and impairs daily functioning such as the ability to manage one’s own activities. Biological changes are believed to start decades before clinical symptoms of Alzheimer’s disease become evident. In the early stages (prodromal to mild dementia), people may have difficulty remembering things, but daily function may or may not be impaired. In the later stage of the disease, people increasingly become reliant on others for even simple day-to-day tasks. Dementia affects 44 million people worldwide with 7.7 million new cases each year, of which Alzheimer’s disease is the most common form. There is no cure for Alzheimer’s disease. Current treatments focus on alleviating symptoms and are unable to stop Alzheimer’s from progressing because they do not affect the disease’s underlying causes.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Roche Diagnostics. Elecsys beta-Amyloid (1-42) CSF: Method sheet. 2018. Last accessed: June 2018.
[2] Roche Diagnostics. Elecsys Phospho-Tau CSF: Method sheet. 2018. Last accessed: June 2018.
[3] Roche Diagnostics. Elecsys Total-Tau CSF: Method sheet. 2018. Last accessed: June 2018.

Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche-global.com
– Nicolas Dunant (Head)
– Patrick Barth
– Ulrike Engels-Lange
– Simone Oeschger
– Anja von Treskow

20180720-Roche_MR_Diagnostics_AAIC_en

Basel, 19 July 2018 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpower132 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of Tecentriq® (atezolizumab) plus chemotherapy (cisplatin or carboplatin plus pemetrexed) reduced the risk of disease worsening or death (PFS) compared to chemotherapy alone in the initial (first-line) treatment of advanced non-squamous non-small cell lung cancer (NSCLC). While a numerical improvement for the co-primary endpoint of overall survival (OS) was observed, statistical significance was not met at this interim analysis, and the study will continue as planned with final OS results expected next year. Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. These data will be presented at an upcoming medical meeting.

“The IMpower132 study showed Tecentriq plus chemotherapy prolonged the time people with this type of advanced lung cancer lived without their disease worsening. We will discuss these results with health authorities.” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development.

About the IMpower132 study
IMpower132 is a Phase III, open-label, randomised study evaluating the efficacy and safety of Tecentriq plus chemotherapy (cisplatin or carboplatin and pemetrexed) versus chemotherapy alone in chemotherapy-naïve patients with NSCLC. The study enrolled 568 people who were randomised equally (1:1) to receive:

  • Tecentriq in combination with cisplatin or carboplatin and pemetrexed (Arm A), or
  • Cisplatin or carboplatin and pemetrexed (Arm B, control arm)

During the treatment-induction phase, people received Tecentriq, pemetrexed and investigator’s choice of either cisplatin or carboplatin on Day 1 of every three weeks for a dosing period of four or six cycles. People who experienced clinical benefit during the induction phase began maintenance therapy until disease progression.

The co-primary endpoints were:

  • PFS as determined by the investigator using RECIST v1.1
  • OS

IMpower132 met its PFS co-primary endpoint as per the study protocol.

About NSCLC
Lung cancer is the leading cause of cancer death globally. [1] Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day.[2] Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.[2] NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope. The squamous form tends to grow near the centre of the lung, and accounts for approximately 25-30% of all NSCLC cases.[3]

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has eight Phase III lung cancer studies underway, evaluating Tecentriq alone or in combination with other medicines.

Tecentriq is already approved in the European Union, United States and more than 70 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

To learn more about the Roche approach to cancer immunotherapy please follow this link: http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htm

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Ferlay J et al. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide. IARC CancerBase No. 11 [Internet]. Lyon France: International Agency for Research on Cancer; 2013. Available from: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx . Accessed June 2018
[2] Barzi A, Pennell NA. Targeting angiogenesis in non-small cell lung cancer: agents in practice and clinical development. European J Clin Med Oncol 2010; 2(1):31-42.
[3] American Cancer Society; what is non-small cell lung cancer [Internet]: https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html. Accessed June 2018.

Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche-global.com
– Nicolas Dunant (Head)
– Patrick Barth
– Ulrike Engels-Lange
– Simone Oeschger
– Anja von Treskow

20180719-Roche_MR-IMpower132_en

Basel, 18 July 2018 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) as an initial (first-line) treatment for people with advanced or metastatic hepatocellular carcinoma (HCC), the most common form of liver cancer. The designation is based on data from a Phase Ib study assessing the safety and clinical activity of the combination of Tecentriq and Avastin.

“Hepatocellular carcinoma is an aggressive cancer with limited treatment options and a major cause of cancer deaths worldwide,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Preliminary data from the combination of Tecentriq and Avastin in this disease are promising and we look forward to working with health authorities to make this potential treatment regimen available to people with hepatocellular carcinoma as soon as possible.”

Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible. This is the 22nd Breakthrough Therapy Designation for Roche’s portfolio of medicines and the 3rd for Tecentriq.

Roche presented data from a Phase Ib study in HCC at the American Society of Clinical Oncology (ASCO) Annual Meeting, in June 2018. These data showed that after a median follow-up of 10.3 months, responses (independent review facility (IRF) per RECIST v1.1) were seen in 15 (65 percent) of 23 efficacy-evaluable patients. Responses were seen in all subgroups, including on the basis of the cause of their disease (etiology: Hepatitis B, Hepatitis C, and non-viral), region (Asia excl. Japan or Japan/US), baseline alpha-fetoprotein levels (high/low) or spread of tumour beyond the liver (yes/no). Assessment by investigators (INV) assessed per RECIST v1.1 demonstrated a response rate of 61 percent (14 out of 23 patients). Median progression free survival (PFS), duration of response (DOR), time to progression (TTP) and overall survival (OS) have not yet been reached after a median follow-up of 10.3 months; results will be presented at a future medical congress when updated data from an expanded cohort are available. In the safety-evaluable population (n=43), 28 percent of patients (n=12) experienced Grade 3-4 treatment-related adverse events and no treatment-related Grade 5 adverse events were observed. No new safety signals were identified beyond the established safety profiles for the individual medicines. Roche provided additional data per FDA request and the Breakthrough Therapy Designation has been granted based on the totality of these data.

Earlier this year, Roche initiated IMbrave150 (NCT03434379), an open-label, multicentre, randomised Phase III study investigating the combination of Tecentriq and Avastin versus sorafenib in people with previously-untreated (first-line) locally advanced, unresectable or metastatic HCC. This study is currently enrolling. Further information about the trial can be found on clinicaltrials.gov.

About the Phase Ib study (NCT02715531)
This Phase Ib, open-label, multicentre study is evaluating the safety and clinical activity of a number of cancer immunotherapy combinations in different solid tumours, including Tecentriq and Avastin in patients with advanced, unresectable or metastatic first-line HCC (Arm A). Participants in Arm A receive Tecentriq (1200 mg) and Avastin (15 mg/kg) intravenously (IV) every three weeks until loss of clinical benefit or unacceptable toxicity. The primary objectives of Arm A are to assess the clinical activity, based on objective response rate (ORR) assessment by independent review facility (IRF) per RECIST v1.1 and to assess the safety and tolerability of the combination. Secondary efficacy endpoints include objective response rate (ORR) by investigator assessment (INV), as well as progression-free survival (PFS), duration of response (DOR), time to progression (TTP) all by INV and IRF per RECIST v1.1; and overall survival (OS).

About Hepatocellular Carcinoma (HCC)
Liver cancer is the second most common cause of cancer death globally[1] and HCC is the most common primary malignancy of the liver. Globally, HCC is the fifth most common cancer in men and the seventh most common cancer among women, with over half a million new cases diagnosed annually[1]. HCC develops predominantly in those people with cirrhosis due to chronic hepatitis B or C[2].

About IMbrave150 (NCT03434379)
IMbrave150 is a Phase III, multicentre, randomised, open-label study enrolling approximately 480 people with untreated advanced, unresectable or metastatic HCC 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq will be administered IV, 1200mg on day 1 of each 21-day cycle and Avastin will be administered IV, 15mg/kg on day 1 of each 21-day cycle. Sorafenib will be administered by mouth, 400mg twice per day, on days 1-21 of each 21-day cycle. Participants will receive the combination or the control arm treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Co-primary endpoints are OS and investigator-assessed ORR. Secondary endpoints include investigator-assessed PFS, TTP, DOR and IRF-assessed ORR, PFS, TTP and DOR.

About the Tecentriq® (atezolizumab) and Avastin® (bevacizumab) combination
There is a strong scientific rationale to support the use of Tecentriq and Avastin in combination. The Tecentriq and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers. Avastin, in addition to its established anti-angiogenic effects, may further enhance Tecentriq’s ability to restore anti-cancer immunity, by inhibiting vascular endothelial growth factor (VEGF)-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens.

About Tecentriq® (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Tecentriq is already approved in the European Union, United States and more than 70 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).

About Avastin® (bevacizumab)
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumour blood supply is thought to be critical to a tumour’s ability to grow and spread in the body (metastasize).

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with TECENTRIQ to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

To learn more about the Roche approach to cancer immunotherapy please follow this link: http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htm.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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References
[1] Ferlay J et al. GLOBOCAN 2012, Liver Cancer: Estimated Incidence, Mortality and Prevalence Worldwide 2012. http://globocan.iarc.fr/old/FactSheets/cancers/liver-new.asp. Accessed May 2018.
[2] Raza A and Sood GK. Hepatocellular carcinoma review: Current treatment, and evidence-based medicine. World J Gastroenterol.2014; 20(15): 4115-4127.

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