Does patient sex affect the treatment outcome of immune checkpoint inhibitors? A Danish, observational melanoma study.

The objective of this study was to evaluate whether patient biological sex influences treatment outcomes in patients with metastatic melanoma (MM) undergoing first-line immune checkpoint inhibitor (ICI) therapy. The Danish Metastatic Melanoma Database (DAMMED) was employed to identify patients who underwent first-line ICI therapy for MM in Denmark from 2013 to 2021. Excluding adjuvant treatment, uveal and mucosal histological subtypes, the study conducted univariable and multivariable analyses to evaluate the influence of patient sex in survival analyses. Further, landmark survival of this real-world national cohort was described for progression free survival (PFS), overall survival (OS) and melanoma-specific survival (MSS). The analysis encompassed a cohort of 1378 patients with MM. Compared to male sex, females had significantly improved OS (p = 0.003) when tested in univariable testing. Multivariable analyses, controlling for age, performance status, lactate dehydrogenase level, BRAF status, M-stage, and number of metastatic sites revealed significant favourable outcomes associated with female sex irrespective of the considered survival metrics (p In this nationwide cohort of patients with MM undergoing first-line ICI treatment females exhibited superior treatment outcomes compared to males. Sex was identified as an independent predictive variable for treatment outcomes, irrespective of the chosen outcome measures considered. Our analyses are not able to conclude whether the differences in outcome is attributable to differences in biology or to treatment strategy.

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Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: LB served on the advisory board of Bristol-Myers Squibb, Roche, Novartis, Merck, EISAI, and Bayer Healthcare. HS received honoraries for consultancies and lectures from Novartis, Merck, Bristol-Myers Squibb, and Incyte; and restricted research grants from MSD. EE received honoraries for consultancies and lectures from Novartis, Merck, Bristol-Myers Squibb, and Pierre Fabre, and conference and travel coverage from Pierre Fabre and Merck. CAH received honoraries for lectures from GSK and Bristol Myers Squibb. Christina Ruhlmann reports personal fees (speaker) from Bristol Myers Squibb (BMS), Helsinn Healthcare SA, Pharmanovia, Merck Sharpe & Dohme (MSD) and Astellas Pharma, and funding for clinical trials from Helsinn Healthcare SA and the Novo Nordic Foundation. All remaining authors have declared no conflicts of interest.