Merck’s Keytruda Gets Second Breakthrough Designation

Merck’s cancer drug Keytruda has received its second FDA breakthrough therapy designation, this time for advanced non-small cell lung cancer.

The designation covers NSCLC patients with certain factors whose disease has progressed after platinum-based chemotherapy. The agency’s decision was based on a trial in which NSCLC patients had an interim median progression-free survival of between 27 and 37 weeks. The trial also found that 80 percent of patients with measurable disease on a baseline scan saw their tumors shrink, Merck said.

The FDA approved Keytruda and designated it a breakthrough therapy for advanced melanoma cancer in September.

The drug belongs to a new class of therapies called PD-1 inhibitors, which work to disable the signal that the cancer cells release to restrict the body’s natural anti-cancer defenses.

While most lung cancer patients get an average of two to three additional months of survival following chemotherapy, PD-1 inhibitors have shown the ability to give 20 to 30 percent of patients additional years of life, said David Carbone, M.D., chairman of the Lung Cancer Foundation of America’s Scientific Advisory Board and Ohio State University professor of medicine.

Researchers are currently using PD-1 inhibitors as first-line treatments in clinical trials and finding that some patients never even need to have chemotherapy, he said.

The first PD-1 inhibitor — Bristol-Myers Squibb’s Opdivo (nivolumab) — was approved in Japan in July. Merck now is studying its drug in confirmatory trials of advanced melanoma, as well as in trials for some 30 other types of cancers, including advanced lung cancers. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.