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Dr Kelly on Final OS and Long-Term DFS Benefit With Adjuvant Nivolumab After CRT in GEJ Cancer

Ronan J. Kelly, MD, expanded on data from the phase 3 CheckMate 577 study of adjuvant nivolumab following CRT in resected esophageal and GEJ cancer.

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    "[Overall, adjuvant nivolumab] was well tolerated, and we think these results further support adjuvant as a standard of care in this disease setting. It's also interesting that the FDA has approved subcutaneous nivolumab for patients with resected esophageal and GEJ cancer with residual disease after trimodality therapy, so that offers an alternative route for administration."

    Ronan J. Kelly, MD, the chief of oncology, the W.W. Caruth, Jr. Chair in Immunology, and the founder and director of the Texas Cancer Interception Institute at Baylor Scott & White Health, discussed final overall survival (OS) results and extended follow-up data from the phase 3 CheckMate 577 trial (NCT02743494), which evaluated adjuvant nivolumab (Opdivo) in patients with resected esophageal or gastroesophageal junction (GEJ) cancer following neoadjuvant chemoradiotherapy (CRT).

    Findings presented during the 2025 ASCO Annual Meeting demonstrated that the disease-free survival (DFS) benefit with adjuvant nivolumab remained durable at a minimum follow-up of 5 years, Kelly reported. Median DFS doubled from 10.8 months (95% CI, 8.3-14.3) in the placebo arm (n = 262) to 21.8 months (95% CI, 16.6-29.7) in the nivolumab arm (n = 532), with a hazard ratio (HR) of 0.76 (95% CI, 0.63-0.91). This DFS advantage was further supported by improvement in the exploratory end point of distant metastasis-free survival, he added.

    The final OS analysis revealed a numerical improvement in median OS with adjuvant nivolumab (16.4-month increase vs placebo), though this difference did not reach the prespecified statistical threshold for significance (HR, 0.85; 95.87% CI, 0.79-1.04; P = .1044), Kelly noted. However, the 5-year OS rate was higher in the nivolumab arm, suggesting a clinically meaningful benefit. Importantly, a subgroup analysis showed that patients with PD-L1 combined positive score (CPS) of 1 or more derived greater OS benefit (HR, 0.79; 95% CI, 0.64-0.99), representing the first evidence that PD-L1 may serve as an enrichment biomarker in the early-stage setting.

    Safety results remained consistent with prior reports, with no new safety signals observed during extended follow-up. Nivolumab continued to demonstrate a favorable toxicity profile, further supporting its use in the adjuvant setting. A post hoc analysis accounting for subsequent lines of therapy also indicated a survival benefit with nivolumab compared with placebo.

    Kelly also noted the recent FDA approval of subcutaneous nivolumab for the treatment of patients with resected esophageal or GEJ cancer and residual disease after trimodality therapy, which may enhance treatment accessibility and convenience. Overall, these results reinforce the role of adjuvant nivolumab as a standard of care in this patient population, Kelly concluded.


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