BMS Presents P-III (CheckMate -76K) Trial Results of Opdivo (nivolumab) for Completely Resected Stage IIB or IIC Melanoma at SMR 2022
Shots:
- The P-III (CheckMate -76K) trial evaluating Opdivo (480mg, q4w for ~12mos.) vs PBO in 790 patients with completely resected stage IIB or IIC melanoma
- The results showed a significant & clinical benefit in RFS. In a pre-specified interim analysis, the trial met its 1EPs of RFS & showed a 58% reduction in risk of recurrence or death, 12mos. RFS rates were 93% vs 84% in stage IIB and 84% vs 72% in stage IIC, RFS benefit was observed across predefined subgroups incl. T category & disease stage
- The safety profile was consistent with prior reported studies with no new safety signals, grade 3/4 TRAEs (10% vs 2%), and TRAE-related discontinuation (15% vs 3%). Opdivo was approved in 65+ countries, incl. the US, the EU, Japan & China
Ref: Businesswire | Image: BMS
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