ESMO 2025 | CheckMate 238: 9-year outcomes of adjuvant nivolumab vs ipilimumab in melanoma
Paolo Ascierto, MD, Istituto Tumori Fondazione Pascale, Naples, Italy, comments on the final nine-year results from the Phase III CheckMate 238 trial (NCT02388906) comparing adjuvant nivolumab versus ipilimumab in patients with resected stage IIIB–C or IV melanoma. Nivolumab continued to demonstrate superior long-term recurrence-free survival, with favorable distant metastasis-free survival and progression-free survival through next-line therapy. Overall survival and melanoma-specific survival remained high, and no new late-emergent safety signals were observed. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
So during this ESMO, we reported the final results of the CheckMate 238. CheckMate 238 is a randomized phase 3 trial, which compared nivolumab versus ipilimumab as an active comparator in high-risk melanoma patients as adjuvant. That means patients with stage 3B, 3C, and 4 resected. The final results confirm, in terms of relapse-free survival, that nivolumab is better than the active comparator ipilimumab...
So during this ESMO, we reported the final results of the CheckMate 238. CheckMate 238 is a randomized phase 3 trial, which compared nivolumab versus ipilimumab as an active comparator in high-risk melanoma patients as adjuvant. That means patients with stage 3B, 3C, and 4 resected. The final results confirm, in terms of relapse-free survival, that nivolumab is better than the active comparator ipilimumab. Even in terms of distant metastases-free survival, there is this trend of a superiority of nivolumab versus ipi. And even with the progression-free survival too, that means the progression from the first progression to the second progression. Nivolumab continues to be better. Overall survival, no difference. Really similar with just some point of percentage in favor of nivolumab. But this can be explained that the active comparator ipilimumab patients were treated at progression with anti-PD-1. It was a sort of crossover and the overall survival looks really similar. Anyway, the message is nivolumab continues to be a treatment that we should offer to other patients because it’s less toxic than ipilimumab, showing better relapse-free survival, PFS2, this is a metastasis-free survival, and even if the overall survival is similar to ipilimumab, it means that it’s similar to an active comparator, so compared to nothing, it’s truly better. There is another interesting post-hoc analysis with this trial, which is how could it be important the time of the administration of a drug because during ASCO we’ve seen several reports that this may make a difference in terms of efficacy and safety and we have seen in terms of relapse-free survival for the patients where the majority of cycles were done before 1 p.m. or after 1 p.m. The majority means more than 75% of cycles. For the pooled analysis, for the patients treated with ipilimumab, RFS-free survival was better in the patients treated before 1 p.m. compared to after 1 p.m. Not significant, but interesting. For nivolumab, similar results before or after 1 p.m. Overall survival, similar results. Safety, for both Nivo and Ipi, during the morning, there was a small less side effect compared to the afternoon. Having said that, these data are interesting, but we need to confirm this in a prospective study in other analysis.
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