Merck to withdraw dangling accelerated approval for Keytruda in third-line stomach cancer
In a first for the dangling accelerated approvals reviewed by FDA’s oncology adcomm in April, Merck on Thursday afternoon agreed to pull a third-line stomach cancer indication for its blockbuster Keytruda after late-stage confirmatory trials failed to show clinical benefit.
This indication was just one of two (out of six total votes) negative votes from the outside experts at the meeting. ODAC voted 6-2 against keeping Keytruda as a third-line treatment for stomach cancer, and panelists pointed to the changing treatment landscape as earlier in April, another checkpoint inhibitor, Bristol Myers Squibb’s Opdivo, won full approval from the FDA and showed positive overall survival benefit as a first-line treatment for stomach cancer.
Rick Pazdur, FDA’s head of oncology, spoke up at the ODAC meeting on this indication, noting the unintended consequences of keeping Keytruda here as physicians might see checkpoint inhibitors as options in the first or third line, even though positive overall survival results have only been seen in the first line with Opdivo. And as more receive checkpoint inhibitors in the first-line setting, fewer will receive it in the third-line setting, said Steven Lemery, acting director of FDA’s Division of Oncology 3.
This accelerated approval for Keytruda first came in September 2017, but Keytruda still has three other accelerated approval indications in different types of stomach cancer, all of which were approved based on tumor response rate and durability of response.
“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,” Scot Ebbinghaus, VP of clinical research at Merck Research Laboratories, said in a statement.
Merck’s clinical program in gastric cancer includes three first-line Phase III trials, KEYNOTE-811, KEYNOTE-859 and LEAP-015, as well as KEYNOTE-585 in the neoadjuvant and adjuvant setting.