Adjuvant Nivolumab Shows Sustained Benefit in Esophageal/GEJ Cancer
Arturo Loaiza-Bonilla, MD, MSEd, discusses 5-year data from the phase 3 CheckMate 577 trial, presented at the 2025 ASCO Annual Meeting.
Arturo Loaiza-Bonilla, MD, MSEd, systemwide chief of hematology and oncology at St. Lukes University Health Network and co-founder and chief medical officer at Massive Bio, discusses 5-year data from the phase 3 CheckMate 577 trial (NCT02743494), presented at the 2025 ASCO Annual Meeting.1
The study showed a confirmed durable benefit with adjuvant nivolumab (Opdivo) in patients with resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT). While the primary overall survival (OS) analysis did not reach statistical significance, the extended OS and higher 5-year OS rates suggest a clinically meaningful effect, particularly when adjusted for post-trial treatments.
CheckMate 577 randomized 794 patients with stage II to III EC/GEJC and residual pathologic disease after R0 resection and neoadjuvant CRT in a 2:1 ratio to receive either nivolumab or placebo for one year. At a median follow-up of 78.3 months, the DFS benefit remained robust: 21.8 months with nivolumab vs 10.8 months with placebo (HR, 0.76). Distant metastasis-free survival was also improved, with a median of 27.3 months in the nivolumab group versus 14.6 months in the placebo group (HR, 0.75).2
OS analysis demonstrated a median improvement of 16.4 months with nivolumab, though the difference did not reach formal statistical significance (OS at 5 years: 46% vs 41%). Notably, survival curves separated after 18 months and remained favorably divergent, reinforcing the long-term benefit. Adjusting for imbalances in subsequent therapies—received by 60% of placebo patients vs 46% in the nivolumab arm—yielded an adjusted HR for OS of 0.73, supporting a survival benefit.
Subgroup analyses suggested that patients with esophageal cancer (HR, 0.69) derived more OS benefit than those with GEJC (HR, 1.14). Additionally, PD-L1 combined positive score (CPS) ≥1 was associated with improved OS (HR, 0.79), while those with CPS <1 showed no clear benefit (HR, 1.40), highlighting CPS as a potential biomarker for future patient selection.
Nivolumab was well tolerated, with mostly grade 1–2 treatment-related adverse events and no treatment-related deaths.
These findings reinforce the role of adjuvant nivolumab as standard of care in resected EC/GEJC with residual disease, with emerging biomarker data potentially refining patient selection in future practice.
