Bristol Myers presents landmark 10-year follow-up data from CheckMate -067

Bristol Myers announced 10-year follow-up data from CheckMate -067, a randomized, double-blind, Phase 3 clinical trial, which showed continued durable improvement in survival with first-line Opdivo plus Yervoy therapy and Opdivo monotherapy, versus Yervoy alone, in patients with previously untreated advanced or metastatic melanoma. With a minimum follow up of 10 years, median overall survival was 71.9 months with Opdivo plus Yervoy – the longest reported median OS in a Phase 3 advanced melanoma trial – 36.9 months with Opdivo and 19.9 months with Yervoy. Among all randomized patients in the trial, 64% of patients who received the combination, 50% of Opdivo-treated patients and 33% of Yervoy-treated patients did not receive subsequent systemic therapy at the 10-year follow up mark. In addition, at 10 years of follow up, the Opdivo plus Yervoy combination showed melanoma-specific survival rates of 52% compared to 44% and 23% among patients treated with Opdivo alone and Yervoy alone, respectively. Durable, sustained clinical benefit was also observed with Opdivo plus Yervoy or Opdivo alone across relevant subgroups, including in patients with BRAF mutation and wild-type tumors. Among patients with BRAF-mutant tumors, the rate of OS at 10 years was 52% in patients who received Opdivo plus Yervoy, 37% for Opdivo alone, and 25% for Yervoy alone. In patients with BRAF wild-type tumors, the rate of OS at 10 years was 39% in patients who received Opdivo plus Yervoy, 37% for Opdivo alone and 17% for Yervoy alone. At 10 years of follow up, the objective response rate was higher for the two Opdivo groups, in combination with Yervoy and alone, at 58.3% and 44.9%, respectively than the Yervoy group at 19.0%. The median duration of response was not reached for those who received Opdivo plus Yervoy, while the median DoR was 103.2 months for Opdivo-treated patients and 19.2 months for Yervoy-treated patients. The safety profile for Opdivo plus Yervoy was consistent with prior findings, with no new safety signals observed and no additional treatment-related deaths occurring since the prior three analyses. Grade 3/4 treatment-related adverse events were reported in 62.6% of patients in the combination group, 24.6% of patients in the Opdivo group, and 29.6% of patients in the Yervoy group.