Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
The approval is based on data from the CheckMate -069 study, in which previously untreated patients had a statistically significant increase in confirmed objective response rate for those with BRAF wild-type melanoma treated with the Opdivo + Yervoy Regimen [60% (95% CI: 48–71; P<0.001)] compared to those treated with Yervoy monotherapy [11% (95% CI: 3–25)]. Complete responses were seen in 17% of patients; partial responses were seen in 43% of patients receiving the combination treatment and 11% in those receiving Yervoy alone. Opdivo + Yervoy demonstrated a 60% reduction in the risk of progression vs. Yervoy alone (HR=0.40; 95% CI: 0.22–0.71; P<0.002) and median progression-free survival (PFS) was 8.9 months for the combination treatment and 4.7 months for Yervoy alone (95% CI: 2.8–5.3).
Opdivo, a programmed death-1 (PD-1) immune checkpoint inhibitor, and Yervoy, a cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor, are both monoclonal antibodies that target separate, distinct checkpoint pathways.
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