FDA Approves Nivolumab Plus Ipilimumab for Unresectable, Metastatic Melanoma

The U.S. Food and Drug Administration (FDA) has approved nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

Approval is based on data from the CheckMate 069 study, which evaluated nivolumab plus ipilimumab in previously untreated patients with unresectable or metastatic melanoma.

Results showed that the confirmed objective response rate in patients with BRAF wild-type disease was 60% (95% CI: 48-71; P<0.001) with nivolumab plus ipilimumab compared with 11% (95% CI: 3-25) in patients treated with ipilimumab alone.

The study also demonstrated a median progression-free survival of 8.9 months with the combination regimen compared with 4.7 months with ipilimumab monotherapy.

In regard to safety, serious adverse events, adverse reactions leading to permanent discontinuation or dose delays, and grade 3 or 4 adverse events were all more common with nivolumab plus ipilimumab compared with ipilimumab alone.

The most common adverse events reported in patients receiving the combination regimen were rash, pruritus, headache, vomiting, and colitis.

“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. 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,” said Giovanni Caforio, chief executive officer, Bristol-Myers Squibb.

The American Cancer Society estimates that about 73,870 new melanomas will be diagnosed in the United States in 2015 and nearly 10,000 people will die from the disease.

Reference

1. Bristol-Myers Squibb receives approval from the U.S. Food and Drug Administration for the Opdivo (nivolumab) + Yervoy (ipilimumab) regimen in BRAF V600 wild-type unresectable or metastatic melanoma [news release]. Princeton, NJ: Bristol-Myers Squibb; October 1, 2015. Accessed October 1, 2015.