Bristol Myers Squibb (BMY)

[DewDiligence]

Keytruda monotherapy-vs-placebo DFS HR=0.76 in adjuvant* NSCLC, irrespective of PD-L1 status, in phase-3 KEYNOTE-091 trial:

https://www.businesswire.com/news/home/20220317005084/en

Although the DFS endpoint was statig, the effect size was so-so (HR=0.76). The statsig outcome was reported on 1/10/22 (https://www.merck.com/news/mercks-keytruda-pembrolizumab-showed-statistically-significant-improvement-in-disease-free-survival-versus-placebo-as-adjuvant-treatment-for-patients-with-stage-ib-iiia-non-small-cell/ ), but the details were not disclosed until today.

Curiously, in the pre-specified subgroup with PD-L1>=50%, Keytruda’s DFS compared to placebo had a non-statsig HR=0.82—a worse result than in the overall trial.

The HR for OS, a secondary endpoint that is not yet mature, was 0.87.

All told, this is not a great dataset, IMO, but it may be enough for FDA approval. These data may put Keytruda at a competitive disadvantage to Tecentriq and Opdivo in early-stage NSCLC.

*Stage 1b-IIIa.