Merck, Eisai notch full approval for Keytruda-TKI inhibitor combo in advanced endometrial cancer
Merck PD-1 inhibitor Keytruda has been in the hot seat as the FDA rifles through its accelerated approval program for drugs that eventually flop confirmatory studies. But for a Keytruda combo with an Eisai TKI inhibitor in endometrial cancer, that won’t be an issue.
The FDA on Thursday gave its full approval to a combination of Keytruda and TKI inhibitor Lenvima to treat second-line or later patients with advanced endometrial carcinoma without a genetic mismatch repair deficiency or high microsatellite instability, the drugmakers said Thursday.
These patients are not eligible for curative surgery or radiation, making them a difficult-to-treat population with just a 17% chance of survival after five years, Memorial Sloan Kettering’s Vicky Makker said in a statement.
The agency based its review on results from the Phase III KEYNOTE-775/Study 309 trial, where the combo reduced the risk of death by 32% compared with investigators’-choice chemotherapy. Keytruda-Lenvima also hit the co-primary PFS endpoint, reducing the risk of progression or death by 40% with an objective response rate of 30% and a complete response rate of 5%.
Merck and Eisai previously held an accelerated approval from the FDA in this indication, which was granted back in September 2019 based on results from the Phase II KEYNOTE-146 study showing significant tumoral response.
It’s a big win for Merck, whose superstar I/O drug has been targeted by the FDA as part of a cleanup effort for drugs that score an accelerated approval but later fail their confirmatory trials. Back in April, the FDA’s Oncologic Drugs Advisory Committee pored over six such cases, with Keytruda taking home a split victory with the committee downvoting its case in third-line stomach cancer and supporting continued approvals in hepatocellular carcinoma and first-line bladder cancer.
Earlier this month, Merck followed up that vote by formally withdrawing its accelerated nod in third-line stomach cancer, making the first of two no votes during that ODAC meeting to do so. 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.