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Press Release: Roche's Tecentriq in combination with Avastin increased overall survival and progression-free survival in people with unresectable hepatocellular carcinoma

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First Phase III cancer immunotherapy study to show an improvement in
overall survival and progression-free survival for the treatment of the
most common form of liver cancer

Data will be submitted to health authorities globally, including the U.S.
Food and Drug Administration, the European Medicines Agency and the China
National Medical Products Administration



Basel, 21 October 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today
announced that the Phase III IMbrave150 study, evaluating Tecentriq(R)
(atezolizumab) in combination with Avastin(R) (bevacizumab) as a
treatment for people with unresectable hepatocellular carcinoma (HCC)
who have not received prior systemic therapy, met both of its co-primary
endpoints demonstrating statistically significant and clinically
meaningful improvements in overall survival (OS) and progression-free
survival (PFS) compared with standard-of-care sorafenib.



Safety for the combination of Tecentriq and Avastin was consistent with
the known safety profiles of the individual medicines, with no new
safety signals identified. Data from the IMbrave150 study will be
presented at an upcoming medical meeting.



"We are very pleased with the results of our study testing the
combination of Tecentriq and Avastin, which marks the first treatment in
more than a decade to improve overall survival in people with
unresectable hepatocellular carcinoma who have not received prior
systemic therapy," said Levi Garraway, M.D. Ph.D, Chief Medical Officer
and Head of Global Product Development. "HCC is a major cause of death
globally and particularly in Asia, making this study an important step
in our mission of addressing unmet medical needs for patients around the
world. We will submit these data to global health authorities as soon as
possible. Our hope is to bring a new treatment to people with this
aggressive disease who currently have limited options."



In July 2018, the U.S. Food and Drug Administration (FDA) granted
Breakthrough Therapy Designation (BTD) for Tecentriq in combination with
Avastin in HCC based on data from an ongoing Phase Ib trial.



Roche has an extensive development programme for Tecentriq, including
multiple ongoing and planned Phase III studies, across lung,
genitourinary, skin, breast, gastrointestinal, gynaecological, and head
and neck cancers. This includes studies evaluating Tecentriq both alone
and in combination with other medicines.



About the IMbrave150 study

IMbrave150 is a global Phase III, multicentre, open-label study of 501
people with unresectable HCC who have not received prior systemic
therapy. People were randomised 2:1 to receive the combination of
Tecentriq and Avastin or sorafenib. Tecentriq was administered
intravenously, 1200 mg on day 1 of each 21-day cycle, and Avastin was
administered intravenously, 15 mg/kg on day 1 of each 21-day cycle.
Sorafenib was administered by mouth, 400 mg twice per day, on days 1-21
of each 21-day cycle. People received the combination or the control arm
treatment until unacceptable toxicity or loss of clinical benefit as
determined by the investigator. Co-primary endpoints were OS and PFS by
independent-review facility (IRF) per RECIST v1.1. Secondary efficacy
endpoints included overall response rate (ORR), time to progression
(TTP) and duration of response (DOR), as measured by RECIST v1.1
(investigator-assessed [INV] and IRF) and HCC mRECIST (IRF), as well as
patient-reported outcomes (PROs), safety and pharmacokinetics.



About hepatocellular carcinoma

HCC is an aggressive cancer with limited treatment options and is a
major cause of cancer deaths worldwide. (1) The disease affects over
750,000 people every year, (1,2) with the majority of cases in Asia and
almost half of all cases in China. (2,3) In the US, the number of liver
cancer cases have more than tripled since 1980 and HCC represents the
fastest rising cause of cancer-related death (4,5) . HCC develops
predominantly in people with cirrhosis due to chronic hepatitis (B or C)
or alcohol consumption, and typically presents at an advanced stage. (1)
The prognosis for unresectable HCC remains poor, with few systemic
therapeutic options and a 1-year survival rate of less than 50%
following diagnosis.(6)



About the Tecentriq and Avastin combination

There is a strong scientific rationale to support the use of Tecentriq
plus 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

Tecentriq is a monoclonal antibody designed to bind with a protein
called PD-L1, which is 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 is a cancer immunotherapy that has the potential to be
used as a foundational combination partner with other immunotherapies,
targeted medicines and various chemotherapies across a broad range of
cancers. The development of Tecentriq and its clinical programme is
based on our greater understanding of how the immune system interacts
with tumours and how harnessing a person's immune system combats cancer
more effectively.



Tecentriq is approved in the US, EU and countries around the world,
either alone or in combination with targeted therapies and/or
chemotherapies in various forms of non-small cell and small cell lung
cancer, certain types of metastatic urothelial cancer, and in
PD-L1-positive metastatic triple-negative breast cancer.



About Avastin

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 (metastasise).



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:

https://www.globenewswire.com/Tracker?data=IOVfYIduAS7A_wS_DCKhIRu8pAUQczgqaM0GurCS3-wxRyi4Ruzg2-clSvZh7KjnRadLjZs3wxbFBEl-0zhZD5Mk1Hb2TWc7sLPluQkv4a6b2A6RLuETBcNnNngxoj4UZxRg8z2D8f8XSKoGt6d3Lf4DJz-0ZUW2h9HOdB_TXnO7VPWaU4xVuvcferEpBPNBVZObyX7i-1sQpfH4Fq38IGJCemY_6oE1ZuJPnbsmR-j7EH_XxbusenD-HYMl1_5GbCr_fejdWmASjz6jiMgaT3Wng7P5V-oXjKT77_ErHHukUN3y64YUuO3UTVBqhBF2
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. More than 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
eleventh consecutive year, Roche has been recognised as one of the most
sustainable companies 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 2018 employed about 94,000 people worldwide. In
2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8
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
https://www.globenewswire.com/Tracker?data=Ues8DjlLV0s7ckQtZhbspbBx0NKda5_4uGdzrpB9120XuCFD2NKczJJvBEbPHyzX2IPZwrjcmZXr_HTIZ4J8vQ
www.roche.com.



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



References

[1] Llovet JM et al. Hepatocellular carcinoma. Nat Rev Dis Primers.
2016; 2:16 018.


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October 21, 2019 01:00 ET ( 05:00 GMT)
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