FDA Approves First Combination Immunotherapy for Melanoma
- By BSTQ Staff
In October, the U.S. Food and Drug Administration (FDA) approved Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of advanced melanoma. It is the first and only approved regimen of two immunotherapy agents in cancer. Opdivo (a PD-1 checkpoint inhibitor) and Yervoy (a CTLA-4 checkpoint inhibitor) are both a type of immunotherapy that acts to release the brakes on the immune system to recognize and mount an attack against cancer. Yervoy was approved by FDA in 2011 as the first therapy to show improved survival in patients with metastatic melanoma. Opdivo was approved in 2014 after showing impressive response rates in patients with previously treated unresectable or metastatic melanoma.
The approval is based on results from the CheckMate 069 study, a Phase II trial evaluating Opdivo plus Yervoy versus Yervoy alone in previously untreated patients with advanced melanoma. The study showed an increase in objective response rate with the Opdivo plus Yervoy regimen (60 percent) compared with Yervoy therapy alone (11 percent). Complete responses were reported in 17 percent of patients, while a partial response was observed in 43 percent of patients in the Opdivo plus Yervoy group. The Opdivo plus Yervoy combination therapy also resulted in a 60 percent reduction in the risk of progression compared with Yervoy alone. Progression-free survival was 8.9 months for the combination therapy compared with 4.7 months with Yervoy alone.
