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Bristol Myers Squibb adopts positive CHMP opinion for Opdivo plus Yervoy for patients with Microsatellite instability high or mismatch repair deficient metastatic colorectal cancer

Bristol Myers Squibb has announced that the CHMP of the EMA has recommended approval of Opdivo  plus Yervoy for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient unresectable or metastatic colorectal cancer. Of significance, the CheckMate -8HW trial results showed reduction in the risk of disease progression or death by 79%  compared to chemotherapy in this patient population.

“Approximately 5-7% of metastatic colorectal cancer patients have dMMR or MSI-H tumors, and current treatment options often do not provide sufficient benefit,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb. “This is the first dual checkpoint inhibitor treatment for first-line metastatic colorectal cancer, delivering a transformative benefit for MSI-H/dMMR patients in this population. We are focused on bringing Opdivo plus Yervoy to these patients in the European Union and look forward to EC’s upcoming decision.”

Note that, the positive opinion is based on results from the CheckMate -8HW trial, which were presented at medical congresses earlier this year. These data formed the basis for the Company’s Type II variation application, which was validated by the EMA In the study, Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoint of progression-free survival compared to the investigator’s choice of chemotherapy as assessed by Blinded Independent Central Review.

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