BMS files sBLA at FDA for combination Opdivo (nivolumab) + Yervoy (ipilimumab) to treat advanced melanoma

BMS announced that the FDA has accepted for filing and review a supplemental Biologics License Application (sBLA) for the combination Opdivo (nivolumab) + Yervoy (ipilimumab) regimen to include clinical data from CheckMate-067, a landmark trial in patients with previously untreated advanced melanoma. The FDA also granted Priority Review for this application with a target action date of 23 January 2016. CheckMate-067 is the first Phase III trial evaluating the nivolumab + ipilimumab regimen or nivolumab monotherapy vs. ipilimumab monotherapy in patients with previously untreated advanced melanoma. Results from CheckMate-067 demonstrated superior progression-free survival (PFS) for the nivolumab + ipilimumab regimen or nivolumab monotherapy vs. ipilimumab monotherapy in previously untreated patients with advanced melanoma, regardless of BRAF status. If approved, this application would expand upon the initial application for the nivolumab + ipilimumab regimen, which was based on tumour response rate and safety data from the Phase II randomised trial, CheckMate-069. The CheckMate-067 trial that serves as the basis for this submission includes comparative PFS and objective response rate data.

Comment: In previous studies, patients with advanced metastatic melanoma have had an objective response rate (ORR, a measure of tumour shrinkage) of 11% when treated with ipilimumab and 41% when treated with nivolumab. The combination had a 40% ORR in the 53 patients treated. But in 16 of those patients (31%), there was a reduction in the size of their tumours of more than 80% in 12 weeks, a sign that the combination might have profound long-term effects for some patients.

In July 2015 EMA validated the submission of the combination for the treatment of advanced (unresectable or metastatic) melanoma in adults.