Merck Keytruda Trial Stopped Early After Meeting Primary Endpoints

An independent monitoring committee has ended a trial of Merck’s Keytruda early, noting that it already met its primary endpoints.

The pivotal, randomized Phase III trial was meant to compare Keytruda (pembrolizumab) with Bristol-Myers Squibb’s Yervoy (ipilimumab) as a first-line treatment for advanced melanoma. Patients were evaluated both for progression-free survival and overall survival, with tumor response assessed at week 12 and then every six weeks.

Specific survival rates are not yet public, spokeswoman Pamela Eisele said.

Keytruda is one of a new class of cancer drugs called PD-1 inhibitors that block the methods tumors use to hide from the immune system. It was granted accelerated approval last fall, meaning the FDA conditionally approved the drug based on reasonable estimates of efficacy.

The other PD-1 inhibitor on the market is BMS’ Opdivo (nivolumab), which is approved as a second-line treatment for melanoma and for non-small-cell lung cancer. Merck says that Keytruda is the first such drug to demonstrate an advantage in survival compared to standard of care as a first-line treatment for melanoma.

The company is planning to share data from this trial with the FDA, Eisele said, though she stopped short of saying that it would specifically support regular approval. — Lena Freund