Merck's Keytruda Missed Survival Goal in Phase III Study

A blockbuster cancer drug hit a road block on its path toward clinical development.

Merck reported pembrolizumab (Keytruda) did not meet the pre-specified primary endpoint of overall survival in a phase III study focusing on previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

“We are encouraged by the positive impact that KEYTRUDA has had on many cancer patients, including those with previously treated recurrent or metastatic head and neck cancer, and we remain confident that KEYTRUDA is an important therapy for this difficult-to-treat cancer,” said Roger Dansey, M.D., senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We look forward to sharing the comprehensive data analysis from KEYNOTE-040 with the scientific community at an upcoming medical meeting.”

While the company didn’t release specific data, it noted the safety profile for the treatment was consistent with previous observations.

The U.S. Food and Drug Administration (FDA) gave Merck fast-track approval last August for Keytruda based on a subset of data that indicated the drug was shrinking tumors, reported Xconomy. The agency required positive results be presented in the future especially evidence of a survival benefit over standard chemotherapy.

However, Merck said in a statement that the current indication remains unchanged and clinical trials for the drug will continue.

The company’s clinical development program for this drug includes tests for over 30 tumor types in over 500 clinical trials. About 300 of these investigations are testing the drug’s efficacy in conjunction with other oncology treatments.

Ultimately, this news could alter the dynamic between Merck and Bristol-Myers Squibb (BMS) as they jockey for control over the immunotherapy space. BMS’s Opdivo received FDA approval in November 2016 for head and neck cancer based on overall survival data.