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Clinical outcomes of adjuvant nivolumab in resected stage III melanoma: comparison of CheckMate 238 trial and real-world data

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2024年5月7日

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  • Justin C. Moser,
  • Shailender Bhatia,
  • Asim Amin,
  • Anna C. Pavlick,
  • Keith A. Betts,
  • Ella Xiaoyan Du,
  • Tayla Poretta,
  • Karishma Shelley,
  • Swetha Srinivasan,
  • Leon Alan Sakkal,
  • Jennell Palaia,
  • Maurice Lobo,
  • Melanie Pe Benito,
  • Joshua A. Linton,
  • Yan Chen,
  • Churong Xu,
  • Lei Yin,
  • Manasvi Sundar,
  • Jeffrey Weber

摘要

Objectives

Nivolumab is approved as adjuvant therapy for resected stage III/IV melanoma based on the phase 3 CheckMate 238 trial. This analysis compared outcomes from CheckMate 238 with those from the real-world Flatiron Health electronic health record-derived de-identified database in patients with resected stage III melanoma (per AJCC-8) treated with adjuvant nivolumab.

Materials

Outcomes included baseline characteristics, overall survival (OS) in the CheckMate 238 cohort (randomization until death or last known alive), and real-world overall survival (rwOS) in the Flatiron Health cohort (nivolumab initiation until death or data cutoff). rwOS was compared with OS using unadjusted and adjusted Cox proportional hazards models. Inverse probability of treatment weighting (IPTW) was combined with the adjusted model to reduce baseline discrepancies.

Results

The CheckMate 238 and real-world cohorts included 369 and 452 patients, respectively (median age, 56.0 and 63.0 years; median follow-up, 61.4 vs. 25.5 months). rwOS was not different from OS in the unadjusted (hazard ratio [HR] 1.27; 95% CI 0.92–1.74), adjusted (HR 1.01; 95% CI 0.67–1.54), and adjusted IPTW (HR 1.07; 95% CI 0.70–1.63) analyses. In the adjusted analysis, 2-year OS and rwOS rates were 84%. Median OS and rwOS were not reached. After IPTW, OS and rwOS were not different (HR 1.07; 95% CI 0.70–1.64).

Conclusions

In this comparative analysis, OS in the CheckMate 238 trial was similar to rwOS in the Flatiron Health database after adjustments in patients with resected stage III melanoma (per AJCC-8) treated with adjuvant nivolumab, validating the trial results.