Jedd D. Wolchok, MD, PhD
The FDA has granted an accelerated approval to the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) as a treatment for patients with BRAF V600
wild-type unresectable or metastatic melanoma, based on findings from the phase II CheckMate-069 study.
The most frequently observed AEs with the combination versus the single-agent were colitis (17% vs 9%), diarrhea (9% vs 7%), pyrexia (6% vs 7%), and pneumonitis (5% vs 0). The most common AEs with the combination versus the single-agent, respectively, were rash (67% vs 57%), pruritus (37% vs 26%), headache (24% vs 20%), vomiting (23% vs 15%), and colitis (22% vs 11%).
“Today’s approval of the Opdivo plus Yervoy Regimen marks another first for our research in immuno-oncology and represents our unwavering commitment to continually redefine cancer care, and offer patients new treatment options with the goal of improved outcomes,” Giovanni Caforio, chief executive officer, Bristol-Myers Squibb, the company developing the drugs, said in a statement.
Nivolumab and ipilimumab are each FDA-approved as single-agents for the treatment of patients with unresectable or metastatic melanoma. In addition to melanoma, the FDA approved nivolumab in March 2015 as a treatment for patients with metastatic squamous non-small cell lung cancer following a platinum-based chemotherapy.
“Targeting the immune system in the treatment of cancer has been of interest to the oncology community for decades, and our first immuno-oncology agent, Yervoy, was approved in 2011 for metastatic melanoma,” said Caforio. “Opdivo reinforced the power of the immune system in the fight against cancer, and is quickly becoming a foundational component in how the oncology community treats this devastating disease.”
Hodi FS, Postow MA, Chesney J, et al. Improved clinical response in patients with advanced melanoma treated with nivolumab combined with ipilimumab compared to ipilimumab alone. Presented at: 2015 AACR Annual Meeting; April 18-22; Philadelphia, PA. Abstract 4214.