The Committee deems that the clinical benefit of OPDIVO (nivolumab) is substantial in the indication: as monotherapy for the adjuvant treatment of adult and adolescent patients aged 12 years and over, with completed resected stage IIB or IIC melanoma.
Clinical Added Value
minor
Taking into account:
evidence in a randomised study versus placebo of superiority of nivolumab on the primary outcome measure, recurrence-free survival where HR=0.42 (CI95% [0.30; 0.59]);
the lack of evidence of a gain in overall survival (immaturity of the data available (ranked secondary outcome measure));
treatment considered to be similar for both adults and adolescents, The efficacy findings of the CheckMate76k study did not include any patients aged ≤ 18 years, the efficacy data for adults were accepted as suitable for extrapolation to adolescents aged 12 years and over,
the Committee deems that, based on the data currently available, OPDIVO (nivolumab) provides, like KEYTRUDA (pembrolizumab), minor clinical added value (CAV IV) as monotherapy for the adjuvant treatment of adult and adolescent patients aged 12 years and over, with completely resected stage IIB, IIC melanoma.
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