In the CheckMate 648 study with 5-year follow-up, nivolumab plus chemotherapy and nivolumab plus ipilimumab continued to demonstrate clinically meaningful survival benefit versus chemotherapy in patients with advanced esophageal squamous cell carcinoma. Both nivolumab-based regimens also showed higher objective response rates and more durable responses compared with chemotherapy in patients with tumor cell PD-L1 >=1%.
Study
|
Randomized, open-label, phase 3 study [CheckMate 648; NCT03143153] |
| Untreated, advanced esophageal squamous cell carcinoma |
| Nivolumab + chemotherapy (n=321) vs Nivolumab + ipilimumab (n=325) vs chemotherapy (n=324)
|
Efficacy
|
PD-L1 >=1% population: |
| ORR: 53% vs 35% vs 20% (Nivolumab + chemotherapy vs. Nivolumab + ipilimumab vs. Chemotherapy) |
| mOS: 15.0 mos vs 13.1 mos vs 9.1 mos (HR for nivo + chemo vs. chemo: 0.62 [0.48-0.79]; HR for nivo + ipi vs. chemo: 0.62 [0.48-0.80]) |
| mPFS: 6.8 mos vs 4.0 mos vs 4.4 mos (HR for nivo + chemo vs. chemo: 0.67 [0.51-0.88]) |
| All randomized patients: |
| ORR: 47% vs 27% vs 27% |
| mOS: 13.2 mos vs 12.7 mos vs 10.7 mos (HR for nivo + chemo vs. chemo: 0.77 [0.65-0.92]) |
| mPFS: 5.8 mos [5.5-7.0] vs 2.9 mos [2.7-4.2] vs 5.6 mos [4.3-5.9] (HR for nivo + chemo vs. chemo: 0.82 [0.68-1.00])
|
Safety
|
Not reported
|
Ann Oncol. Published online August 3 2026
http://doi.org/10.1016/j.annonc.2026.08.001
Reviewed by Ulas D. Bayraktar, MD on Aug 20, 2026
