Two months after a key FDA panel voted down Merck’s conditional nod for Keytruda as a third-line treatment for certain stomach cancer patients, the company says it’s pulling the plug on the indication.
Following consultation with the FDA, Merck on Thursday said it will voluntarily withdraw its U.S. accelerated approval for Keytruda as a third-line monotherapy treatment for PD-L1-positive stomach cancer patients. The removal will begin in six months, Merck said.
The decision comes after the agency’s oncology advisory committee in April voted 6-2 in favor of removing Keytruda’s stomach cancer label. In Keytruda’s confirmatory trials, required under the FDA’s conditional approval, the treatment failed to show it helped patients live longer than chemotherapy alone.
Meanwhile, Bristol Myers’ immuno-oncology rival Opdivo has scored a landmark full FDA approval for previously untreated gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma tumors that are advanced or that have spread to other parts of the body. Opdivo was able to prove it could reduce the risk of death by 20% compared with chemotherapy alone across those diseases.
The FDA’s advisors pointed to Opdivo’s front-line nod to justify their decision to vote down Merck’s third-line use.
While Merck believes there’s still “an unmet need for heavily pre-treated patients with advanced gastric cancer,” the New Jersey-based drugmaker acknowledged on Thursday that “the treatment landscape has evolved.” Merck said it respects the FDA’s decision.
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Not all is lost for Keytruda’s prospects in the hard-to-treat stomach cancer arena. In what some analysts deemed a “positive surprise,” Ketruda recently scored an FDA clearance to treat new patients with HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in tandem with Roche’s anti-HER2 mainstay Herceptin and chemotherapy.
That approval is also under the agency’s accelerated pathway and is based on tumor response and durability of response. That means Merck will still be required to confirm the regimen’s benefits with gold-standard patient survival data.
Merck also has its Phase 3 Keynote-859 trial underway. That study is examining Keytruda in combination with chemotherapy for newly diagnosed patients with advanced gastric or GEJ adenocarcinoma.
Editor’s note: Angus Liu contributed reporting for this story.