No Significant Benefit Demonstrated with Nivolumab/Ipilimumab Versus Nivolumab Alone in Advanced Melanoma

Source: Targeted Oncology, December 2019

The combination of nivolumab (Opdivo) with ipilimumab (Yervoy) showed no statistically significant benefit in patients with stage IIIB/C/D or stage IV (no evidence of disease) melanoma compared with nivolumab alone in the phase III CheckMate 915 study, missing the co-primary endpoint of recurrence-free survival (RFS) in patients with <1% PD-L1 expression in their tumor cells, according to a press release from Bristol-Myers Squibb.1

The phase III study randomized patients to nivolumab 240 mg intravenously every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks or nivolumab alone at 480 mg every 4 weeks to determine if the combination is more effective at delaying the return of cancer after a melanoma resection. The treatment is given for 1 year. In addition to the primary end point of RFS, the study is also evaluating overall survival (OS), and PD-L1 measured by immunoassay, as secondary end points.

The interventional study enrolled 1943 participants starting at age 12 who had a completely resected stage IIIB/C/D or stage IV melanoma and no prior treatment for melanoma. Patients were excluded if they had a history of uveal melanoma, had an active or suspected autoimmune disease, or had received prior treatment with interferon.

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