Abstract
With the recent regulatory approvals, the relatlimab–nivolumab combination brings new expectations and opens avenues toward effective immunotherapy combination in advanced melanoma. This work provides a critical insight into the recent phase II–III RELATIVITY-047 trial (NCT03470922), including a comparison with the CheckMate 067 trial on the current standard ipilimumab–nivolumab combination, with a focus on immune-related adverse events. Some imbalances of rare toxicities were noted, deserving careful monitoring and assessment in the upcoming real-world use. The promising efficacy data, although still early, should be carefully balanced against these toxicities, thus making pharmacovigilance and global patient-level data sharing crucial to identify the target population, promote safer prescribing and eventually clarify its place in therapy.
Plain language summary
Relatlimab plus nivolumab is a novel immunotherapy combination, recently approved by US and EU regulatory agencies for the treatment of advanced melanoma. In the RELATIVITY-047 trial, this combination demonstrated a favorable benefit–risk profile (notable efficacy data coupled with favorable tolerability), especially compared with published data on ipilimumab–nivolumab combination, the current standard of care. Notwithstanding these promising data, its real-world use will be crucial to better characterize its tolerability and positioning the drug within the pharmacological armamentarium.
Papers of special note have been highlighted as: • of interest
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