Media Release

Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for anti-PD1 immunotherapy

 

  • Endometrial cancer is the fourth most common cancer in women in North America
  • VENTANA MMR RxDx Panel is the first IHC predictive test in endometrial cancer for treatment with the anti-PD1 immunotherapy JEMPERLI (dostarlimab-gxly)
  • GSK/Roche collaboration represents an important step towards a personalised healthcare strategy for certain endometrial cancer patients
Tucson, Ariz., June XX, 2020 – 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. 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). Testing can identify patients eligible for treatment with JEMPERLI (dostarlimab-gxly) monotherapy, a new anti-PD1 immunotherapy from GlaxoSmithKline (GSK) that was approved by the FDA on XX.
 
“We are excited to launch this companion diagnostic test with GSK to help recurrent or advanced endometrial cancer patients with limited treatment options,” said Jill German, Head of Roche Tissue Diagnostics. “This test provides clinicians with an effective tool to identify patients best suited for treatment with JEMPERLI, providing a new therapeutic option for women whose disease progresses following initial chemotherapy treatment.”
 
Endometrial cancer is the most common gynecologic malignancy in the U.S. and the fourth most common cancer in women in North America. There are limited treatment options for women whose disease progresses on or after first-line therapy. MMR deficiency is most common in endometrial cancer. 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. The VENTANA MMR RxDx Panel is intended for the assessment of expression of MMR proteins in formalin-fixed, paraffin-embedded (FFPE) tumor tissue stained with OptiView DAB IHC Detection Kit and ancillary reagents in the panel for VENTANA anti-MLH1 (M1), VENTANA anti-MSH2 (G219-1129) and VENTANA anti-MSH6 (SP93) and OptiView DAB IHC Detection Kit with the OptiView Amplification Kit and ancillary reagents for VENTANA anti-PMS2 (A16-4) on a 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.2,3,4 PD-1 inhibitors can be effective in cancers with a high frequency of MMR deficiency and/or MSI-H including endometrial cancer.2,4 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 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 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 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. 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.
  2. Lee YC, S Lheureux, and AM Oza. (2017) Treatment strategies for endometrial cancer: current practice and perspective. Curr Opin Obstet Gynecol. 29, 47-58.
  3. 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/
  4. 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.
  5. Matthews KS, Estes JM, Conner MG, et al. Lynch syndrome in women less than 50 years of age with endometrial cancer. Obstet Gynecol. 2008:111(5):1161-6.
  6. Kim SR, Pina A, Albert A, et al. Does MMR status in endometrial cancer influence response to adjuvant therapy? Gynecol Oncol. 2018:151(1):76-81.

For Further Information

Gabrielle Fimbres

Roche Molecular Solutions Media Relations

520.222.4573

gabrielle.fimbres@roche.com