CheckMate 648: nivolumab combination therapy in advanced oesophageal squamous cell carcinoma
Adding nivolumab to chemotherapy, or combining nivolumab with ipilimumab without chemotherapy, lengthened survival compared with chemotherapy alone in advanced oesophageal squamous cell carcinoma, with the largest gains in PD-L1-positive tumours.
Overview
Phase 3 trial of 970 patients with previously untreated advanced oesophageal squamous cell carcinoma randomised to nivolumab plus fluorouracil-cisplatin, nivolumab plus ipilimumab, or chemotherapy alone.
In tumours with PD-L1 expression of 1 percent or more, median overall survival was 15.4 months with nivolumab-chemotherapy and 13.7 months with nivolumab-ipilimumab against 9.1 months with chemotherapy (hazard ratios 0.54 and 0.64); benefit was also seen in the overall population.
- PD-L1 1 percent or more: median overall survival 15.4 (nivolumab-chemotherapy) and 13.7 (nivolumab-ipilimumab) vs 9.1 months (chemotherapy).
- All randomised: 13.2 and 12.7 vs 10.7 months.
Nivolumab plus chemotherapy or nivolumab plus ipilimumab are first-line standards for advanced oesophageal squamous cell carcinoma, joining pembrolizumab-chemotherapy from KEYNOTE-590.
- Early progression was more frequent with chemotherapy-free nivolumab-ipilimumab.
- Benefit in PD-L1-negative tumours was uncertain.
Similar pages
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