Bristol Myers Squibb (BMY)

[DewDiligence]

More CHECKMATE-227 results—not exactly bullish:

https://investors.bms.com/iframes/press-releases/press-release-details/2019/Bristol-Myers-Squibb-Announces-CheckMate--227-Part-1a-Meets-Co-Primary-Endpoint-of-Overall-Survival/default.aspx

Bristol-Myers Squibb Company today announced that Part 1a of the Phase 3 CheckMate-227 trial evaluating Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) met the co-primary endpoint of overall survival (OS), demonstrating a superior benefit versus chemotherapy in first-line non-small cell lung cancer (NSCLC) patients whose tumors express PD-L1 >=1%. In an exploratory analysis of patients in Part 1b whose tumors do not express PD-L1, a survival benefit was also observed with Opdivo plus low-dose Yervoy.

In other words, Opdivo + (low-dose) Yervoy bested chemo regardless of PD-L1 expression, but only the PD-L1-positive subgroup had been assigned alpha.

Here’s the bad part:

Bristol-Myers Squibb also announced today that Part 2 of the CheckMate -227 trial, evaluating Opdivo plus chemotherapy [i.e. no Yervoy], did not meet the pre-specified primary endpoint of OS versus chemotherapy in patients with non-squamous histology, regardless of PD-L1 status.

The OS HR for Opdivo/chemo vs chemo alone in this patient pool was 0.86 with a 95% CI of [0.69-1.08], according to data posted on BMY’s website.

OS HR=0.86 is not terrible, but this is a patient pool where Keytruda/chemo showed statsig better OS than chemo alone with HR=0.49, so Opdivo has again underperformed relative to Keytruda.

BMY’s 2Q19 CC is tomorrow. Expect plenty of discussion on CHECKMATE-227 in all of its manifold components!

See the quoted section of #msg-146308018 for related info.