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Re: DewDiligence post# 603

Thursday, 09/07/2017 9:01:55 AM

Thursday, September 07, 2017 9:01:55 AM

Post# of 1162
CHECKMATE-214 in RCC stopped for superior efficacy—Opdivo/Yervoy superior OS to Sutent in primary-endpoint subgroup and entire population:

https://finance.yahoo.com/news/checkmate-214-study-evaluating-opdivo-105900824.html

Bristol-Myers Squibb...announced today that a Phase 3 study evaluating Opdivo plus Yervoy in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) met its co-primary endpoint, demonstrating superior overall survival (OS) compared to sunitinib in intermediate- and poor-risk patients.

The combination also met a secondary endpoint of improved OS versus sunitinib in all randomized patients. Based on a planned interim analysis, an independent Data Monitoring Committee (DMC) has recommended that the trial be stopped early.

…The safety and tolerability of the Opdivo plus Yervoy combination observed in CheckMate-214 was consistent with previous reports of this dosing schedule and similar across subgroups.

Three weeks ago (#msg-133869270) when BMY reported the ORR and PFS (but not OS) results from this trial, the stock sold off modestly.

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