OPDIVO/YERVOY (nivolumab/ipilimumab) - Advanced melanoma

The Committee deems that, as for patients without B-RAF mutations, the clinical benefit of the OPDIVO/YERVOY (nivolumab/ipilimumab) association is substantial as a first-line treatment for patients with an ECOG score of 0 or 1, whose tumour exhibits B-RAF mutation, without active brain metastasis.

In view of:

• the evidence of a gain in efficacy in relation to ipilimumab monotherapy, which is not the conventional treatment in this context;
• the increased toxicity (discontinuation of treatment due to adverse event in approximately one in two patients) among selected patients (99.8% in good general health or preserved general health);
• the update in the treatment of patients with BRAF mutation highlighted by the guidelines in force in particular;

the Committee deems that the OPDIVO/YERVOY (nivolumab/ipilimumab) association provides no clinical added value (CAV V) in the therapeutic strategy for adult advanced melanoma patients (see RMP population).