Biotech Values

[DewDiligence]

BMY—FDA approves Opdivo/Yervoy in 1L-NSCLC—for PD-L1>=1%—based on OS data in CHECKMATE-227 study:

https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-nivolumab-plus-ipilimumab-first-line-mnsclc-pd-l1-tumor-expression-1

In Part 1a of CHECKMATE-227, Opdivo/Yervoy was compared to standard chemotherapy for patents with PD-L1>=1%; the HR for OS was 0.79 (95% CI: [0.69, 0.94]; p=0.0066). Today was the PDUFA date.

The part of CHECKMATE-227 that looked at the subgroup of patients with high-TMB never impressed the FDA and was not part of BMY’s sBLA submission, as far as I know. (BMY never talks about TMB anymore.)

Given how colossally unwieldy CHECKMATE-227 was, BMY’s garnering any FDA approval from the trial is a considerable achievement. In the EU, the CHMP deemed CHECKMATE-227 too convoluted to evaluate, so BMY withdrew the MAA (#msg-153600393).

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So, BMY finally has a presence in 1L-NSCLC, although today’s approval may end up being overshadowed by BMY’s sBLA from the CHECKMATE-9LA study, whose PDUFA date is 8/6/20 (#msg-154883951). In CHECKMATE-9LA, which had no lower bound for PD-L1 status, patients in the experimental arm received two cycles of standard chemo followed by the combination of Opdivo and low-dose Yervoy (without chemo); this arm showed statsig-better OS than standard chemotherapy.