FDA grants accelerated approval for Opdivo (nivolumab) + Yervoy (ipilimumab) combination to treat BRAF V600 wild-type metastatic melanoma- BMS

Bristol-Myers Squibb announced that the FDA approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab), for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. This announcement marks the first and only FDA approval of a regimen of two immuno-oncology agents in cancer. This indication is approved under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

The approval is based on data from the pivotal study, CheckMate-069, which was the first to report outcomes of the regimen in previously untreated patients with unresectable or metastatic melanoma. Results from the trial demonstrated a statistically significant (p<0.001) increase in confirmed objective response rate – the study’s primary endpoint – in patients with BRAF wild-type melanoma treated with the nivolumab/ipilimumab regimen [60% (95% CI: 48–71; p<0.001)] compared to those treated with ipilimumab monotherapy [11% (95% CI: 3–25)]. Complete responses were seen in 17% of patients. Partial responses were seen in 43% of the combination group and 11% of the ipilimumab monotherapy group. The nivolumab/ipilimumab regimen demonstrated a 60% reduction in the risk of progression vs ipilimumab alone (HR=0.40; 95% CI: 0.22–0.71; p<0.002). Median PFS was 8.9 months with the combination (95% CI: 7.0–NA) and 4.7 months with ipilimumab alone (95% CI: 2.8–5.3).