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<p>Neoadjuvant ipilimumab plus nivolumab has become standard therapy for stage III melanoma based on the NADINA trial, although long-term data are lacking. In the phase 2 PRADO cohort of OpACIN-neo, 99 patients with stage III macroscopic melanoma received this regimen. Here we report first-time 5-year survival data: 71% event-free survival, 74% relapse-free survival, 79% distant metastasis-free survival and 86% overall survival. Ongoing grade 1−2 immune-related adverse events occurred in 69% of patients alive, predominantly vitiligo and hypothyroidism. Major pathologic response (MPR), high tumor mutational burden (TMB), high interferon-gamma (IFNγ) signature and programmed cell death ligand 1 (PD-L1) expression of 1% or higher were associated with favorable outcomes. Combined high TMB, IFNγ and PD-L1 expression yielded 100% MPR and 100% 5-year event-free survival, whereas triple low expression had only 18% MPR and 41% event-free survival. Our findings demonstrate favorable long-term outcomes for patients with an MPR and identify IFNγ and PD-L1 as promising baseline biomarkers. ClinicalTrials.gov identifier: <a href="http://clinicaltrials.gov/study/NCT02977052">NCT02977052</a>.</p>

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Neoadjuvant ipilimumab plus nivolumab in melanoma: 5-year survival and biomarker analysis from the phase 2 PRADO-trial

  • 期刊论文

  • 发表日期：

    2026年1月28日

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  • Lotte L. Hoeijmakers,
  • Petros Dimitriadis,
  • Steven C. M. A. Wijnen,
  • Irene L. M. Reijers,
  • Marta Lopez-Yurda,
  • Alexander M. Menzies,
  • Annegien Broeks,
  • Sten Cornelissen,
  • Alejandro Torres Acosta,
  • Anja van der Wal,
  • Robyn P. M. Saw,
  • Judith M. Versluis,
  • Winan J. van Houdt,
  • Michel W. Wouters,
  • Jurriaan Romano,
  • Eliza A. Rozeman,
  • Lindsay G. Grijpink-Ongering,
  • Ellen Kapiteijn,
  • Astrid A. M. van der Veldt,
  • Karijn P. M. Suijkerbuijk,
  • Hanna Eriksson,
  • Geke A. P. Hospers,
  • Jos A. van der Hage,
  • Dirk J. Grünhagen,
  • Arjen J. Witkamp,
  • Judith M. Lijnsvelt,
  • Willem M. C. Klop,
  • Charlotte L. Zuur,
  • Annemarie Bruining,
  • Abrahim Al-Mamgani,
  • Thomas E. Pennington,
  • Kerwin F. Shannon,
  • Sydney Ch’ng,
  • Andrew J. Colebatch,
  • Maria Gonzalez,
  • Andrew J. Spillane,
  • John B. A. G. Haanen,
  • Robert V. Rawson,
  • Richard A. Scolyer,
  • Bart A. van de Wiel,
  • Alexander C. J. van Akkooi,
  • Georgina V. Long,
  • Christian U. Blank

摘要

Neoadjuvant ipilimumab plus nivolumab has become standard therapy for stage III melanoma based on the NADINA trial, although long-term data are lacking. In the phase 2 PRADO cohort of OpACIN-neo, 99 patients with stage III macroscopic melanoma received this regimen. Here we report first-time 5-year survival data: 71% event-free survival, 74% relapse-free survival, 79% distant metastasis-free survival and 86% overall survival. Ongoing grade 1−2 immune-related adverse events occurred in 69% of patients alive, predominantly vitiligo and hypothyroidism. Major pathologic response (MPR), high tumor mutational burden (TMB), high interferon-gamma (IFNγ) signature and programmed cell death ligand 1 (PD-L1) expression of 1% or higher were associated with favorable outcomes. Combined high TMB, IFNγ and PD-L1 expression yielded 100% MPR and 100% 5-year event-free survival, whereas triple low expression had only 18% MPR and 41% event-free survival. Our findings demonstrate favorable long-term outcomes for patients with an MPR and identify IFNγ and PD-L1 as promising baseline biomarkers. ClinicalTrials.gov identifier: NCT02977052.