Article Dans Une Revue British Journal of Dermatology Année : 2025

Neoadjuvant immune checkpoint inhibitors for patients with resectable stage III/IV melanoma: A nationwide real-life study in France (NEOMEL)

Charlotte Cavalieri
  • Fonction : Auteur
Emilie Gérard
Eve Maubec
Candice Lesage
Bertille Bonniaud
  • Fonction : Auteur
  • PersonId : 994655
  • IdRef : 155899635
Henri Montaudié
Mona Amini-Adle
Samy Belkaid
Florent Grange
Sandrine Mansard
Emilie Tournier
  • Fonction : Auteur

Résumé

Despite the clear therapeutic benefits of neoadjuvant treatment (NT) with immune checkpoint inhibitors (ICIs) in clinical trials, the efficacy of NT ICIs (NT-ICI) and the optimal regimen for patients (pts) with resectable metastatic melanoma (RMM) remain to be confirmed in real life. Objective To assess the efficacy and safety of NT-ICI among pts with RMM in real life. Methods NEOMEL is a French retrospective multicentric cohort study. Dermato-oncologists from the French group of skin cancers included pts treated with NT-ICI for RMM (AJCC 8th stage III or IV) between July 2016 and April 2024. Pts were treated either with NT anti-programmed cell death protein-1 (anti-PD-1) monotherapy or with the combination of anti–cytotoxic T lymphocyte-associated protein-4 (anti-CTLA-4) plus anti-PD-1 (1-mg/kg ipilimumab (IPI) and 3-mg/kg nivolumab (NIVO); or 3-mg/kg IPI and 1-mg/kg NIVO). The primary endpoint was the pathological complete response (pCR) rate. The secondary endpoints were pathological response according to the International Neoadjuvant Melanoma Consortium criteria, radiological response, the occurrence of immune-related adverse events (irAEs) including those of ≥ grade 3 and outcomes with recurrence-free survivals (RFS) and event-free survivals (EFS). Results Among the 174 included pts, 149 (86%) underwent surgery. NT-ICI achieved a high pCR rate of 43% (95% CI, 34.9-51.3), including 44.7% (95% CI, 35.4–54.3) with NT-anti-PD-1 and 37.1% (95% CI, 21.5–55.1) with NT-IPI-NIVO (p=0.427). The major (complete + near-complete) pathological response rate was 53.2%. Radiological responses were observed in 49.9% of pts, including 12 complete responses (12.1%), of which 91.7% (n=11) corresponded to pCR. Severe immune-related adverse events (irAEs) occurred more frequently with NT-IPI-NIVO (24.4%) compared to NT-anti-PD-1 (3.1%) (p<0.001). The median RFS was 29.61 months (95% CI, 27.70-not reached [NR]) with significantly higher RFS in pts with pCR than no-pCR (HR, 0.218 [95% CI, 0.082–0.583], p=0.0009). The median EFS was 35.7 months 2 (95% CI, 28-NR). Conclusion In this retrospective real-life study, NT-ICI confirms its efficacy in RMM pts, achieving high pathological response rates. However, dual checkpoint inhibition with IPI-NIVO was associated with a higher risk of severe irAEs. These findings underscore the relevance of NT-ICI for RMM in clinical practice and required further confirmation.

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Dates et versions

hal-05236270 , version 1 (02-09-2025)

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Charlée Nardin, Charlotte Cavalieri, Céleste Lebbé, Emilie Gérard, Marc Puyraveau, et al.. Neoadjuvant immune checkpoint inhibitors for patients with resectable stage III/IV melanoma: A nationwide real-life study in France (NEOMEL). British Journal of Dermatology, 2025, ⟨10.1093/bjd/ljaf268⟩. ⟨hal-05236270⟩
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