Bristol-Myers Squibb said Thursday that the FDA approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. The company noted that the move marks the first and only approval of a regimen of two immuno-oncology agents in cancer in the US. Opdivo and Yervoy are immune checkpoint inhibitors that target the complementary checkpoint pathways PD-1 and CTLA-4, respectively.
Approval of the combination regimen was supported by safety and efficacy data from the Phase II CheckMate -069 trial in previously untreated patients with unresectable or metastatic melanoma. Results from the study, which were unveiled in April, illustrated that the combination regimen was associated with a significantly higher objective response rate than Yervoy alone. The company later announced late-stage study data demonstrating that the combination was linked to prolonged progression-free survival compared to either monotherapy.
Opdivo was launched in Japan in September last year, becoming the first PD-1 inhibitor available anywhere in the world. The therapy was subsequently awarded accelerated approval by the FDA for the treatment of melanoma, and later cleared for the treatment of advanced squamous non-small-cell lung cancer in certain patients.
Meanwhile, Yervoy has been approved by regulators in the US in addition to Europe and Australia for the treatment of advanced melanoma. For related analysis on the melanoma market, see Malignant Melanoma: Update Bulletin.
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