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Background <p>Immune checkpoint inhibitors (ICIs) have revolutionized the management of advanced melanoma. SWOG S1801 demonstrated improved event-free survival (EFS) with neoadjuvant pembrolizumab compared with adjuvant therapy alone in resectable stage III/IV melanoma patients. Similarly, the NADINA trial demonstrated improved EFS by using neoadjuvant ipilimumab plus nivolumab compared to adjuvant nivolumab. We conducted a retrospective study to evaluate outcomes associated with neoadjuvant versus adjuvant ICI in real-world patients with stage III/IV melanoma.</p> Methods <p>We reviewed records from our prospectively-maintained IRB-approved institutional database from January 2020 to December 2024 to identify consented patients with clinically detectable stage IIIB to IIID or oligometastatic stage IVA to IVC melanoma who had intended curative-intent surgery and received ICI preoperatively (neoadjuvant) and postoperatively (adjuvant) or only adjuvantly. The patients had to have at least 12 months of follow-up or an event to be included. The primary endpoint was EFS, defined as time from diagnosis of stage III or IV melanoma to recurrence, progression, or death. Secondary endpoints included pathological response in the neoadjuvant group.</p> Results <p>A total of 159 patients met the inclusion criteria: 102 received neoadjuvant ICI, and 57 received only adjuvant ICI. In a landmark analysis, EFS at 1 year was 79.2% (95% confidence interval [CI] 71.6–87.5) in the neoadjuvant group and 54.7% (95% CI 43.2–69.3) in the adjuvant-only group. The EFS at 2 years was 68.9% (95% CI 59.9–79.2) in the neoadjuvant group and 46.3% (95% CI 34.7–61.8) in the adjuvant only group (<i>p</i> = 0.05). The median follow-up was 28.7 months (IQR 18.5–41.3) in the neoadjuvant group and 30.1 months (IQR 19.5–41.8) in the adjuvant group. Major pathologic response was observed in 56 (54.9%) patients, partial pathologic response in 11 (10.8%), no response in 23 (22.5%), and progression in 12 (11.8%) patients treated with neoadjuvant ICI.</p> Conclusions <p>In this single-academic institution analysis, neoadjuvant ICI was associated with improved 2-year EFS compared with adjuvant ICI in patients with advanced melanoma, consistent with prospective data from SWOG 1801 and NADINA. This evidence validated the integration of neoadjuvant ICI therapy into clinical practice and underscores the importance of real-world validation.</p>

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Implementing Paradigm Shifting Clinical Trials: Real-World Outcomes of Neoadjuvant Versus Adjuvant Immune Checkpoint Inhibitors in Advanced Melanoma Patients

  • 期刊论文

  • 发表日期：

    2026年6月26日

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  • Kristen E. Dougherty,
  • Gray B. Peery,
  • Ananya Saravanan,
  • Veronica P. Pham,
  • Kelly Herremans,
  • Stergios J. Moschos,
  • Frances A. Collichio,
  • David W. Ollila

摘要

Background

Immune checkpoint inhibitors (ICIs) have revolutionized the management of advanced melanoma. SWOG S1801 demonstrated improved event-free survival (EFS) with neoadjuvant pembrolizumab compared with adjuvant therapy alone in resectable stage III/IV melanoma patients. Similarly, the NADINA trial demonstrated improved EFS by using neoadjuvant ipilimumab plus nivolumab compared to adjuvant nivolumab. We conducted a retrospective study to evaluate outcomes associated with neoadjuvant versus adjuvant ICI in real-world patients with stage III/IV melanoma.

Methods

We reviewed records from our prospectively-maintained IRB-approved institutional database from January 2020 to December 2024 to identify consented patients with clinically detectable stage IIIB to IIID or oligometastatic stage IVA to IVC melanoma who had intended curative-intent surgery and received ICI preoperatively (neoadjuvant) and postoperatively (adjuvant) or only adjuvantly. The patients had to have at least 12 months of follow-up or an event to be included. The primary endpoint was EFS, defined as time from diagnosis of stage III or IV melanoma to recurrence, progression, or death. Secondary endpoints included pathological response in the neoadjuvant group.

Results

A total of 159 patients met the inclusion criteria: 102 received neoadjuvant ICI, and 57 received only adjuvant ICI. In a landmark analysis, EFS at 1 year was 79.2% (95% confidence interval [CI] 71.6–87.5) in the neoadjuvant group and 54.7% (95% CI 43.2–69.3) in the adjuvant-only group. The EFS at 2 years was 68.9% (95% CI 59.9–79.2) in the neoadjuvant group and 46.3% (95% CI 34.7–61.8) in the adjuvant only group (p = 0.05). The median follow-up was 28.7 months (IQR 18.5–41.3) in the neoadjuvant group and 30.1 months (IQR 19.5–41.8) in the adjuvant group. Major pathologic response was observed in 56 (54.9%) patients, partial pathologic response in 11 (10.8%), no response in 23 (22.5%), and progression in 12 (11.8%) patients treated with neoadjuvant ICI.

Conclusions

In this single-academic institution analysis, neoadjuvant ICI was associated with improved 2-year EFS compared with adjuvant ICI in patients with advanced melanoma, consistent with prospective data from SWOG 1801 and NADINA. This evidence validated the integration of neoadjuvant ICI therapy into clinical practice and underscores the importance of real-world validation.