CHMP recommends Opdivo (nivolumab)+ Yervoy (ipilimumab) for treatment of advanced melanoma in adults- BMS

Bristol-Myers Squibb Company announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Opdivo in combination with Yervoy for the treatment of advanced (unresectable or metastatic) melanoma in adults.

The CHMP also added an informative statement to the broad indication that relative to Opdivo monotherapy, an increase in progression-free survival (PFS) for the combination of Opdivo with Yervoy is established only in patients with low tumor PD-L1 expression. This CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union. Opdivo monotherapy is already approved by the EC for advanced melanoma and previously treated advanced squamous non-small cell lung cancer (NSCLC), and was recommended for approval by the CHMP in February for previously treated advanced or metastatic non-squamous NSCLC and renal cell carcinoma (RCC).

The CHMP adopted the positive opinion based on data from two trials, CheckMate -067 and CheckMate -069, in addition to supportive data from CA209-004, a Phase 1b study which evaluated the combination of Opdivo and Yervoy in patients with advanced melanoma. CheckMate -067 is a Phase III, double-blind trial which evaluated Opdivo in combination with Yervoy or Opdivo monotherapy vs. Yervoy monotherapy in patients with previously untreated advanced melanoma, and included patients with both BRAF V600 mutation-positive and wild-type advanced melanoma. The co-primary endpoints were PFS and overall survival (OS). CheckMate -069 is a Phase II, double-blind, randomized study which evaluated Opdivo in combination with Yervoy vs. Yervoy monotherapy in patients with previously untreated unresectable or metastatic melanoma, and included patients with both BRAF wild-type and BRAF V600 mutation-positive melanoma. The primary endpoint was objective response rate (ORR) in patients with BRAF wild-type tumors. Secondary endpoints included PFS in patients with BRAF wild-type tumors, ORR in patients with BRAF V600 mutation positive tumors, and safety. Overall survival was an exploratory endpoint.