The Committee deems that the clinical benefit of OPDUALAG (nivolumab/relatlimab) 240 mg/80 mg, solution for dilution for infusion, substantial only as a first-line treatment of advanced (unresectable or metastatic) melanoma for adult and adolescent patients aged 12 years and over with tumour cell PD-L1 expression below 1%, with an ECOG score of 0 or 1 and exhibiting no active brain metastasis.
Insufficient
The Committee deems that the clinical benefit of OPDUALAG (nivolumab/relatlimab) 240 mg/80 mg, solution for dilution for infusion, is insufficient in other contexts to justify public funding.
Clinical Added Value
minor
In view of:
evidence of superiority of the nivolumab – relatlimab association in relation to nivolumab only in terms of progression-free survival (HR= 0.75; 95% CI [0.62; 0.92]; p=0.0055) [ITT population], with a point estimation of the absolute difference on the medians of 5.49 months in a randomised double-blind phase 3 study;
progression-free survival findings suggesting heterogeneity of the treatment effect according to the PD-L1 level (interaction test: p= 0.0301), in favour of the patient subgroup with a tumour PD-L1 expression < 1% [MA population];
treatment considered to be similar for both adults and adolescents. The RELATIVITY 047 study did not include any adolescents, the efficacy data for adults were accepted as suitable for extrapolation to adolescents aged 12 years and over;
and despite:
the lack of evidence of a gain in overall survival;
a safety profile particularly marked by an increase in grade 3-4 AEs (22% of the patients of the nivolumab + relatlimab group and 12.0% of the patients of the nivolumab group) and in SAEs (16.1% and 8.4%), considered as treatment-related;
the lack of formal conclusions that can be drawn from the exploratory secondary outcome measure findings including quality of life;
the lack of comparative data in relation to the nivolumab - ipilimumab association and thus the inability to define the precise role of nivolumab/relatlimab treatment in relation to the nivolumab - ipilimumab association;
the Committee deems thatOPDUALAG (nivolumab/relatlimab) 240 mg/80 mg, solution for dilution for infusion, provides minor clinical added value (CAV IV) in relation to nivolumab as a first-line treatment of advanced (unresectable or metastatic) melanoma for adult and adolescent patients aged 12 years and over with tumour cell PD-L1 expression below 1%, with an ECOG score of 0 or 1 and exhibiting no active brain metastasis.
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