Press Release : Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy

 
   -- About 90,000 women globally die from endometrial cancer each year1 
 
   -- VENTANA MMR RxDx Panel is the first immunohistochemistry predictive test 
      in endometrial cancer for treatment with the anti-PD1 immunotherapy 
      JEMPERLI (dostarlimab-gxly) 
 
   -- Roche/GSK collaboration represents an important step towards a 
      personalised healthcare strategy that can help identify patients who are 
      most likely to benefit from a specific therapy 
 
 
   Basel, 23 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today 
announced U.S. Food and Drug Administration (FDA) approval of the 
VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer 
patients. MMR is a molecular mechanism that functions to correct certain 
errors that can spontaneously occur during DNA replication. Testing can 
identify patients eligible for treatment with JEMPERLI 
(dostarlimab-gxly) monotherapy, an anti-PD1 immunotherapy from 
GlaxoSmithKline (GSK) that was approved by the FDA on 22 April 2021. 
 
   Endometrial cancer is the most common gynecologic cancer in the U.S. and 
the fourth most common cancer in women in North America.(2) In addition, 
about 90,000 women globally die from endometrial cancer each year.(1) 
There are limited treatment options for women whose disease progresses 
on or after first-line therapy and this is the first companion 
diagnostic to identify endometrial cancer patients eligible for anti-PD1 
immunotherapy. 
 
   "We are excited to launch this companion diagnostic test with GSK to 
help recurrent or advanced endometrial cancer patients with limited 
treatment options," said Thomas Schinecker, CEO of Roche Diagnostics. 
"This test provides clinicians with an effective tool to identify 
patients best suited for treatment with GSK's JEMPERLI, providing a new 
therapeutic option for women with MMR-deficient endometrial cancer whose 
disease progresses on or following initial chemotherapy treatment." 
 
   MMR deficiency is most common in endometrial cancer. This companion 
diagnostic (CDx) provides clinicians with a standardised testing option 
that uses a comprehensive panel of DNA mismatch repair (MMR) biomarkers 
tested by immunohistochemistry (IHC). FDA approval of the VENTANA MMR 
RxDx Panel provides clinicians with access to a fully automated, 
easy-to-use MMR test to identify patients who are eligible for therapy 
with JEMPERLI. 
 
   About the VENTANA MMR RxDx Panel 
 
   The VENTANA MMR RxDx Panel is a label expansion of Roche's current 
on-market VENTANA MMR IHC Panel. VENTANA MMR RxDx Panel is a qualitative 
immunohistochemistry test intended for use in the assessment of mismatch 
repair (MMR) proteins (MLH1, PMS2, MSH2 and MSH6) in formalin-fixed, 
paraffin-embedded (FFPE) endometrial carcinoma tissue by light 
microscopy. The OptiView DAB IHC Detection Kit is used for MLH1, MSH2 
and MSH6, and the OptiView DAB IHC Detection Kit with the OptiView 
Amplification Kit is used for PMS2 on a VENTANA BenchMark ULTRA 
instrument. DNA mismatch repair (MMR) proteins have been clinically 
proven to be predictive biomarkers for PD-1 targeted therapy; 
specifically, a loss of expression of one or more MMR proteins might 
predict an increased likelihood of response to such therapy.(3,4,5) PD-1 
inhibitors can be effective in cancers with a high frequency of MMR 
deficiency and/or microsatellite-instability, high (MSI-H) including 
endometrial cancer.(3,5) MMR is a conserved molecular mechanism that 
functions to correct the improper base substitutions that spontaneously 
occur during DNA replication. Defects in the MMR machinery have been 
attributed to mutations in the MMR proteins. 
 
   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 
twelfth 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 2020 employed more than 100,000 people worldwide. 
In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 
58.3 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] Bray F, Ferlay J, et al, Global cancer statistics 2018: GLOBOCAN 
estimates of incidence and mortality worldwide for 36 cancers in 185 
countries. CA Cancer J Clin. (2018) 68:394--424. 10.3322/caac.21492 
 
   [2] Lortet-Tieulent J, J Ferlay, F Bray, and A Jemal. (2018) 
International patterns and trends in endometrial cancer incidence, 
1978-2013. J Natl Cancer Inst. 110, 354-361. 
 
   [3] Lee YC, S Lheureux, and AM Oza. (2017) Treatment strategies for 
endometrial cancer: current practice and perspective. Curr Opin Obstet 
Gynecol. 29, 47-58. 
 
   [4] GSK website, 
https://www.gsk.com/en-gb/media/press-releases/data-from-garnet-study-indicates-robust-activity-of-dostarlimab-in-patients-with-advanced-or-recurrent-endometrial-cancer/ 
 
 
   [5] Kato M, Takano M, Miyamoto M, et al. DNA mismatch repair-related 
protein loss as a prognostic factor in endometrial cancers. J Gynecol 
Oncol. 2015:26(1):40-45. 
 
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April 23, 2021 01:00 ET (05:00 GMT)