BMS Reports 6.5-Year Follow-Up Data from CheckMate-067 Trial Demonstrating Durable Survival Benefit of Opdivo Plus Yervoy in First-Line Advanced Melanoma

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On May 19, Bristol-Myers Squibb announced new 6.5-year data from the randomized, double-blind, phase 3 CheckMate-067 clinical trial. The results demonstrate that, in the first-line treatment of advanced melanoma, Opdivo + Yervoy combination therapy continues to improve survival compared to Opdivo monotherapy and Yervoy monotherapy, with nearly half of patients still alive at the 6.5-year follow-up. In contrast, a decade ago, patients diagnosed with metastatic melanoma had a median survival of only 6 months, and fewer than 10% of patients survived beyond 5 years.

The 6.5-year follow-up results from the CheckMate-067 trial will be presented at the 2021 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting held in early June. The specific data are as follows:

With a minimum follow-up of 6.5 years, the median overall survival (OS) for patients in the Opdivo + Yervoy treatment arm was 72.1 months (95% CI: 38.2–NR), representing the longest OS reported in a phase 3 clinical trial for advanced melanoma; in comparison, the median OS for the Opdivo monotherapy arm was 36.9 months (95% CI: 28.2–58.7), and for the Yervoy monotherapy arm, it was 19.9 months (95% CI: 16.8–24.6).

In terms of progression-free survival, the 6.5-year PFS rate for patients in the Opdivo + Yervoy treatment group was 34% (median PFS: 11.5 months), compared with 29% (median PFS: 6.9 months) in the Opdivo monotherapy group and 7% (median PFS: 2.9 months) in the Yervoy monotherapy group.

Among the 49% of patients who remained alive at follow-up, 77% (n=112/145) in the Opdivo + Yervoy treatment group, 69% (n=84/122) in the Opdivo monotherapy group, and 43% (27/63) in the Yervoy monotherapy group had discontinued treatment and had not received any subsequent systemic therapy.

Across all relevant subgroups, including patients with BRAF-mutant tumors, BRAF wild-type tumors, and liver metastases, both Opdivo plus Yervoy combination therapy and Opdivo monotherapy demonstrated sustained clinical benefit: (1) In patients with BRAF-mutant tumors: the 6.5-year survival rate was 57% for the Opdivo plus Yervoy group, 43% for the Opdivo monotherapy group, and only 25% for the Yervoy monotherapy group. (2) In patients with BRAF wild-type tumors: the 6.5-year survival rate was 46% for the Opdivo plus Yervoy group, 42% for the Opdivo monotherapy group, and only 22% for the Yervoy monotherapy group. (3) In patients with liver metastases: the 6.5-year survival rate was 38% for the Opdivo plus Yervoy group, 31% for the Opdivo monotherapy group, and only 22% for the Yervoy monotherapy group.

Regarding the median duration of response (DoR), it was not yet reached in the Opdivo + Yervoy treatment group and the Opdivo monotherapy group, whereas it was 19.2 months in the Yervoy monotherapy group.

The safety profile of Opdivo plus Yervoy combination therapy was consistent with previous findings, with no new safety signals observed and no additional treatment-related deaths occurring since the 5-year analysis. Grade 3/4 treatment-related adverse events were reported in 59% of patients in the Opdivo plus Yervoy treatment group, 24% in the Opdivo monotherapy group, and 28% in the Yervoy monotherapy group.

Source: Six-and-a-Half-Year Outcomes for Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Continue to Demonstrate Durable Long-Term Survival Benefits in Patients with Advanced Melanoma