Phase III trial of Keytruda (pembrolizumab) fails to meet primary endpoint in head and neck cancer- Merck Inc

Merck Inc announced that the pivotal phase III KEYNOTE-040 trial investigating Keytruda (pembrolizumab), in previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) did not meet its pre-specified primary endpoint of overall survival (OS). The safety profile observed in KEYNOTE-040 was consistent with that observed in previously reported studies of Keytruda; no new safety signals were identified.

KEYNOTE-040 is a randomized, multi-center, pivotal phase III study investigating Keytruda as a monotherapy versus standard treatment (methotrexate, docetaxel or cetuximab) for the treatment of recurrent or metastatic HNSCC. The primary endpoint is OS; secondary endpoints include progression-free survival (PFS) and overall response rate (ORR).

Comment: in August 2016, the 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 (ClinicalTrials.gov, NCT02358031), a phase III clinical trial of Keytruda in the first-line treatment of recurrent or metastatic HNSCC.