European Commission approves Opdivo for advanced melanoma

The European Commission has approved Opdivo for treating advanced melanoma in adults, regardless of BRAF status, according to a press release from Bristol-Myers Squibb.

The action allows Opdivo (nivolumab, Bristol-Myers Squibb) a PD-1 immune checkpoint inhibitor, to be marketed in all 28 member states of the European Union, according to the release. It is the first approval of a PD-1 inhibitor for any cancer given by European Commission, the release stated.

The approval was based on results of two phase 3 studies, the release stated. The researchers investigated nivolumab, 3 mg/kg every two weeks, in patients with advanced melanoma

“The phase 3 data supporting the approval of Opdivo demonstrates both superior overall survival and response rate for treatment-naive patients with advance melanoma, against the standard of car,” Dirk Schadenorf, MD, professor, director and chair, Clinic for Dermatology, University Hospital, Essen, Germany, said in the release. “It is an important step forward in offering a new option for advanced melanoma patients in the European Union, especially considering that long-term benefits have largely been elusive in this treatment category.”

In Checkmate –066, a phase 3, randomized, double-blind study, 210 patients with treatment-naive advanced melanoma treated with nivolumab were compared with 208 patients treated with chemotherapy dacarbazine. The 1-year survival rate was 73% for the nivolumab arm compared with 42% in the dacarbazine arm. Patients treated with nivolumab also had a 58% decrease in death risk (HR = 0.42; 99.79% CI, 0.25-0.73). Common adverse events reported in the nivolumab-treated cohort included fatigue, pruritus and nausea.

In CheckMate –037, patients with advanced melanoma who were previously treated with Yervoy (ipilimumab, Bristol-Myers Squibb), and if BRAF mutation positive, a BRAF inhibitor, were treated with nivolumab (n=272) or investigator’s choice chemotherapy (n=133) with either single-agent dacarbazine or carboplatin plus paclitaxel. The nivolumab arm had an objective response rate of 32% (95% CI, 23.5%-40.8%) compared with 11% (95% CI, 3.5%-23.1%) in the chemotherapy arm at a planned interim analysis. Most adverse events in the nivolumab arm were grade 1/2, and managed with recommended treatment algorithms

Serious adverse events reported with nivolumab treatment include severe pneumonitis or interstitial lung disease, including fatal cases, diarrhea or immune-mediated colitis, immune-mediated hepatitis, immune-mediated nephritis, immune-mediated hypothyroidism and hyperthyroidism, and possible embryofetal toxicity, according to the release.

The FDA approved Opdivo for treating patients with unresectable or metastatic melanoma and disease progression following ipilimumab, and in BRAF V600 mutation positive, a BRAF inhibitor, in December 2014, the release stated.

Reference: www.bms.com