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Bristol Myers O+Y shows long-term survival benefit in kidney cancer

September 17, 2020

Bristol Myers Squibb (NYSE:BMY) announces updated results from a Phase 3 clinical trial, CheckMate-214, comparing the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) to Pfizer’s (NYSE:PFE) Sutent (sunitinib) in first-line renal cell carcinoma (RCC) patients.

Intermediate- and poor-risk patients (n=847):

Median overall survival (OS) in the O+Y group was 48.1 months versus 26.6 months in the sunitinib group. The four-year OS rate was 50.0% versus 35.8% for sunitinib.

The overall response rate (ORR) favored O+Y, 65% vs. 50%.

Median duration of response (DOR) was not reached in the O+Y group compared to 19.7 months in the sunitinib group.

In the intent-to-treat population (n=1,096), median OS was not reached in O+Y arm compared to 38.4 months in the sunitinib arm. Four-year OS rates were 53.4% and 43.3%, respectively. ORR favored O+Y, 65% vs. 52%. The complete response rate for O+Y was 11% vs. 3% with sunitinib. Median DOR was not reached compared to 23.7 months in the sunitinib arm.

The safety profile of O+Y was “manageable” using established treatment algorithms.

Nick Botwood, M.D., VP, interim head, Oncology Development says, “We have now evaluated Opdivo plus Yervoy in multi-year Phase 3 trials across RCC, melanoma, non-small cell lung cancer and mesothelioma, and in all of these studies, we have seen improved survival compared to the existing standard of care. The four-year results from CheckMate -214 build on our understanding of and leadership in addressing advanced RCC, reinforcing the potential for durable, long-term survival benefits with Opdivo plus Yervoy in the first-line setting. Taken as a whole, these data provide further evidence for the value of distinct but complementary dual checkpoint inhibition in the treatment of advanced cancers.”

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