Adjuvant immune checkpoint inhibitors across solid tumors: a meta-analysis of phase II-III randomized trials - Summary - MDSpire
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Meta-Analysis of Phase II-III Randomized Trials on Adjuvant Immune Checkpoint Inhibitors in Solid Tumors

  • By

  • Mariam Grazia Polito

  • Luisana Sisca

  • Davide Caruso

  • Antonella Cosimati

  • Carla Adriana Ramirez Reinaga

  • Etien Leka

  • Daniele Santini

  • Gian Paolo Spinelli

  • September 7, 2026

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Objective:

To assess the benefit of adjuvant immune checkpoint inhibitors (ICIs) among patients with solid tumors.

Approach:
  • Search Strategy: Systematic search of PubMed, Embase, CENTRAL, and ASCO/ESMO proceedings from January 2015 to June 2026 for phase II and III RCTs evaluating adjuvant ICIs against non-ICI controls.
  • Inclusion Criteria: Included studies with ICI-based adjuvant approaches and randomized comparator arms; excluded single-arm studies and those combining ICIs with non-ICI systemic therapies.
  • Data Analysis: Used random-effects models to pool hazard ratios (HRs) for recurrence-related outcomes (DFS/RFS/PFS) and overall survival (OS).
Key Findings:
  • 21 RCTs included, enrolling 17,446 patients across eight solid tumors.
  • Adjuvant ICIs significantly improved DFS/RFS/PFS (HR 0.74, 95% CI 0.68–0.82, p<0.0001) and OS (HR 0.84, 95% CI 0.78–0.90, p<0.0001).
  • DFS/RFS improvements observed in melanoma (HR 0.65), urothelial carcinoma (HR 0.78), renal cell carcinoma (HR 0.84), and NSCLC (HR 0.87).
  • Significant OS benefits in melanoma (HR 0.76) and urothelial carcinoma (HR 0.85).
Limitations:
  • Small number of studies and differences at the trial level.
  • Possible ecological bias affecting results.
Sources:

Original Source(s)

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