Nivolumab Shows Survival Benefit in Melanoma

Zosia Chustecka

June 26, 2014

The investigational immunotherapy nivolumab (Bristol-Myers Squibb) has shown improved overall survival in advanced melanoma when compared with the standard treatment, dacarbazine, in a comparative phase 3 study that was stopped early due to benefit.

There has been huge excitement over this new agent, an immune checkpoint inhibitor that acts on the programmed death (PD) pathway, for a few years now, after it showed unprecedented response rates in melanoma in an early study.

This latest result, from a study known as CheckMate 066, is "an important milestone in the field of immuno-oncology, as it represents the first well-controlled randomized phase 3 trial of an investigational PD-1 checkpoint inhibitor to demonstrate an overall survival benefit," the company said.

The study has now been stopped and unblinded, and patients who were taking dacarbazine will be offered nivolumab in an open-label extension.

The company-sponsored CheckMate 066 study was designed in consultation with the European Committee for Medicinal Products for Human Use, and was primarily conducted in countries where dacarbazine is a commonly used treatment in the first-line setting, including Canada, but not the United States. It was conducted in 418 patients with previously untreated BRAF wild-type unresectable stage III or IV melanoma, and compared nivolumab 3 mg/kg every 2 weeks or dacarbazine 1000 mg/m² every 3 weeks.

There are several other trails in progress in melanoma, including the phase 3 study known as CheckMate 037, which is comparing nivolumab against chemotherapy in patients who have progressed after ipilimumab (Yervoy, Bristol-Myers Squibb), another immune checkpoint inhibitor but with a different mechanism of action.

Bristol-Myers Squibb is also investigating nivolumab in many different cancer types, in addition to melanoma, and has ongoing trials that could potentially be used for approval in non-small-cell lung cancer (NSCLC), renal cell carcinoma (RCC), head and neck cancer, glioblastoma, and non-Hodgkin's lymphoma. The FDA has granted Fast Track designation for nivolumab in NSCLC, melanoma, and RCC, and for certain patients with Hodgkin's lymphoma.

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