MSD’s Keytruda significantly extended overall survival when used as monotherapy for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in patients expressing PD-L1.
Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC) of the pivotal Phase III KEYNOTE-048 trial, treatment with Keytruda (pembrolizumab) resulted in significantly longer OS compared to cetuximab in combination with platinum chemotherapy (cisplatin or carboplatin) plus 5-Fluorouracil (5-FU), the current standard of care for HNSCC in the first-line treatment setting.
At the time of the interim analysis, the dual-primary endpoint of progression-free-survival (PFS) for patients whose tumors expressed PD-L1 (CPS≥20) had not been reached, the firm added.
“This interim analysis of KEYNOTE-048 trial has shown that Keytruda monotherapy has the potential to help patients with head and neck cancer whose tumors express high-levels of PD-L1,” said Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
These results are to be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide, in the hope of expanding its scope to include the first-line setting.
Keytruda is already approved to treat patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.