Biotech Values

[DewDiligence]

MRK—Keytruda monotherapy in second-line gastric cancer shows non-statsig OS/PFS vs Taxol (OS HR=0.82):

http://www.mrknewsroom.com/news-release/corporate-news/merck-provides-update-keynote-061-phase-3-study-keytruda-pembrolizumab-p

Merck…today announced that the pivotal phase 3 KEYNOTE-061 trial investigating KEYTRUDA…as a second-line treatment for patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma, did not meet its primary endpoint of overall survival (OS) (HR, 0.82 [95% CI, 0.66-1.03]; p=0.042 [one-sided]) in patients whose tumors expressed PD-L1 [Combined Positive Score (CPS) >= 1]. Additionally, progression free survival (PFS) in the PD-L1 positive population did not show statistical significance.

Keytruda recently received FDA accelerated approval in third-line gastric cancer based on ORR in a single-arm trial (#msg-134837349), so Keytruda will now need to show a clinical benefit in first-line gastric cancer for the accelerated approval to be converted into a full approval. A first-line trial is in progress.