Biotech Values

[jbog]

Merck: Phase 3 KEYNOTE-040 trial of KEYTRUDA did not meet primary endpoint Merck announced that the pivotal phase 3 KEYNOTE-040 trial investigating KEYTRUDA, the company's anti-PD-1 therapy, in previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma did not meet its pre-specified primary endpoint of overall survival (HR, 0.82 [95% CI, 0.67-1.01]; p = 0.03 [one-sided]).

The safety profile observed in KEYNOTE-040 was consistent with that observed in previously reported studies of KEYTRUDA; no new safety signals were identified.

In August 2016, the U.S. FDA approved KEYTRUDA for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. The current indication remains unchanged and clinical trials continue, including KEYNOTE-048, a phase 3 clinical trial of KEYTRUDA in the first-line treatment of recurrent or metastatic HNSCC.

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