Phase III Study of Opdivo in Advanced Melanoma meets primary endpoint - BMS

BMS announced results from CheckMate-066, a Phase III randomized double blind study, comparing Opdivo (nivolumab) to the chemotherapy dacarbazine (DTIC) in patients with treatment naïve BRAF wild-type Advanced Melanoma (n=418). The study met the primary endpoint of overall survival (OS) with the median OS not reached for Opdivo vs. 10.8 months for DTIC. The one-year survival rate was 73% for Opdivo vs. 42% for DTIC and there was a 58% decrease in the risk of death for patients treated with Opdivo. This survival advantage was also observed in Opdivo-treated patients in both PD-L1 positive and PD-L1 negative patients.

Safety was reported in all patients treated in the Opdivo and DTIC arms. Fewer discontinuations were observed with Opdivo than DTIC (6.8% vs. 11.7%) as well as for treatment-related Grade 3/4 adverse events (AEs) (11.7% vs. 17.6%), which were managed using established safety algorithms. The most common Opdivo treatment-related AEs were fatigue (20%), pruritus (17%), and nausea (16.5%). Findings from CheckMate-066 were published in The New England Journal of Medicine and presented during an oral session at the Society for Melanoma Research 2014 International Congress. See: "Nivolumab in Previously Untreated Melanoma without BRAF Mutation" Caroline Robert et al. NEJM November 16, 2014DOI: 10.1056/NEJMoa1412082