Merck announced plans to withdraw the U.S. accelerated approval indication for KEYTRUDA (pembrolizumab) for treatment of patients with recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma, with disease progression on or after two or more prior lines of therapy.

KEYTRUDA failed to meet its post-marketing requirement as a monotherapy demonstrating no overall survival benefit in a Phase 3 study. As agreed with the FDA, Merck will initiate the withdrawal in six months. Patients being treated with KEYTRUDA for metastatic gastric cancer in the third- or further-line setting should discuss their care with their health care provider. This decision does not affect other indications for KEYTRUDA.

“While there remains an unmet need for heavily pre-treated patients with advanced gastric cancer, we recognize that the treatment landscape has evolved and we respect the FDA’s efforts to continually evaluate accelerated approvals,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “Our research with KEYTRUDA has contributed to recent advances in the treatment of gastric cancer, and we are continuing to advance studies to help more patients with this disease.”

KEYTRUDA will continue to play an important role in the treatment of certain patients with gastric cancer:

KEYTRUDA is indicated under accelerated approval for:

• locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma.

• unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors 

• unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors 

These indications are approved under accelerated approval based on tumor response rate and durability of response; continued approval for these indications may be contingent upon verification and description of clinical benefit in the confirmatory trials.