Merck Keytruda fails in head and neck cancer trial
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells.
Rahway: Merck, known as MSD outside the United States and Canada, has announced that the Phase 3 KEYNOTE-412 trial evaluating KEYTRUDA (pembrolizumab), Merck's anti-PD-1 therapy, with concurrent chemoradiation therapy (CRT) followed by KEYTRUDA as maintenance therapy (the KEYTRUDA regimen), did not meet its primary endpoint of event-free survival (EFS) for the treatment of patients with unresected locally advanced head and neck squamous cell carcinoma (HNSCC).
At the final analysis of the study, there was an improvement in EFS for patients who received the KEYTRUDA regimen compared to placebo plus CRT; however, these results did not meet statistical significance per the pre-specified statistical plan. The safety profile of KEYTRUDA in this trial was consistent with previously reported studies in HNSCC.
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Head and neck cancer describes a number of different tumors that develop in or around the throat, larynx, nose, sinuses and mouth. Most head and neck cancers are squamous cell carcinomas that begin in the flat, squamous cells that make up the thin surface layer of the structures in the head and neck.
"There have been limited advances for patients with locally advanced HNSCC, and unfortunately, these results suggest that this disease remains very challenging to treat," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. "We are proud of the significant role KEYTRUDA plays in the treatment of certain later stages of HNSCC, and we are committed to investigating KEYTRUDA-based regimens for this debilitating type of cancer in earlier stages of disease. We are grateful to the patients and investigators for their participation in this study."
KEYTRUDA is currently approved as monotherapy and in combination regimens for appropriate patients with metastatic or with unresectable, recurrent HNSCC in the U.S., Europe, China, Japan and other countries around the world.
