Two-year study of Opdivo (nivolumab) shows superiority in advanced melanoma- BMS

BMS has announced new long-term data of Opdivo (nivolumab) in treatment-naïve BRAF wild-type advanced melanoma from CheckMate -066. In the trial, Opdivo continued to demonstrate superior overall survival versus dacarbazine with 57.7% of patients alive at two years compared to 26.7% of patients treated with dacarbazine. The safety profile of Opdivo was consistent with prior studies. The two-year survival and safety data from CheckMate -066 represent the longest follow-up from a randomized study of any PD-1 immune checkpoint inhibitor in the first-line setting of advanced melanoma.

In the trial, patients administered Opdivo demonstrated increased OS compared to dacarbazine. With a minimum follow-up of 15.1 months, Opdivo continued to demonstrate significantly improved OS with the median OS not reached (NR) versus 11.2 months with dacarbazine. Overall survival rates were 70.7% and 57.7% for Opdivo and 46.3% and 26.7% for dacarbazine at 12 and 24 months, respectively. Subsequent treatment was used in 72.1% of patients in the dacarbazine arm, with 27 (13%) patients receiving Opdivo as the subsequent therapy. ORR and PFS also continued to be significantly greater with Opdivo. Objective response rate was 42.9% for Opdivo with 11% of patients achieving a complete response, compared to a 14.4% ORR for dacarbazine with 1% of patients achieving a complete response. These data will be presented at the Society for Melanoma Research (SMR) 2015 International Congress.

Comment: According to an assessment by IQWiG, treatment-naive patients with BRAF V600 mutation-negative tumour have an advantage in overall survival with this drug. This advantage varies by sex, however. The results on side effects are uncertain, and it is therefore not possible to balance benefit and harm. But there is no sign that a negative effect in side effects could completely outweigh the positive effect in overall survival. IQWiG therefore sees an indication of considerable added benefit of nivolumab in comparison with dacarbazine in men, and a hint of a minor added benefit in women.