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Re: DewDiligence post# 862

Wednesday, 07/24/2019 5:31:55 PM

Wednesday, July 24, 2019 5:31:55 PM

Post# of 1162
More details on Part 2 of CHECKMATE-227 in this (separate) PR this afternoon:

https://finance.yahoo.com/news/bristol-myers-squibb-provides-part-201600295.html

Bristol-Myers Squibb Company…today announced that Part 2 of the Phase 3 CheckMate -227 trial did not meet the primary endpoint of overall survival (OS) with Opdivo® (nivolumab) plus chemotherapy versus chemotherapy in patients with first-line non-squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 status (HR 0.86; 95% CI 0.69-1.08). The median OS for patients treated with Opdivo plus chemotherapy was 18.83 months vs. 15.57 months for chemotherapy, and the landmark one-year OS was 67.3 percent vs. 59.2 percent, respectively.

In an exploratory analysis of patients with first-line squamous NSCLC, the median OS was 18.27 months for Opdivo plus chemotherapy vs. 11.96 months for chemotherapy (HR 0.69; 95% CI 0.50-0.97). No new safety signals were observed. The company will share complete findings from this trial at an upcoming medical meeting.

Unfortunately for BMY, OS for the squamous subgroup was not a pre-specified endpoint, which is why the above narrative calls those data “exploratory.”

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