ArticleJournal for immunotherapy of cancer2026
Evaluating the potential of candidate surrogate endpoints for overall survival in treatment-naive metastatic melanoma treated with anti-PD-1-based regimens with or without anti-CTLA-4 therapy.
Article in Journal for immunotherapy of cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundUsing surrogates for overall survival (OS) may expedite the development of, and patient access to, novel treatments. We assessed potential surrogates for OS in patients with metastatic melanoma treated with nivolumab-containing regimens in the first-line treatment setting.
methodsWe used individual-patient data from 1865 patients enrolled in four randomized controlled trials studying single-agent nivolumab or combinations of nivolumab and ipilimumab against dacarbazine or immunotherapy. Using the two-level meta-analytic framework, we evaluated three candidate surrogates: objective response rate (ORR), progression-free survival (PFS), and time to next treatment or death (TNTD). We measured the patient-level associations between candidates and OS using ORs in the case of ORR and Spearman's correlation coefficient (ρ) in the case of time-to-event surrogate endpoints. We used R
resultsFor ORR, at the individual-level, OR of survival was equal to 12.29 (95% CI 9.78 to 14.80), and at the trial-level R
conclusionAt the individual-level, ORR exhibited a strong correlation with OS, whereas PFS and TNTD showed a moderate level correlation with OS. At the trial level, the key requirement for validating surrogates, all candidate surrogates demonstrated moderate predictive abilities for OS in future trials. These findings should be interpreted within the context of anti-PD-1-based therapies, with or without anti-CTLA-4 combinations, consistent with the trial evidence base included in this study.
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