Table 9.
Clinical studies in esophageal squamous cell carcinoma.
| Patient group | Treatment | Participants (n) | Trial, ID | Outcomes | Reference |
|---|---|---|---|---|---|
| Advanced ESCC | Nivolumab + ipilimumab | 325 | Phase 3, NCT03143153 (CheckMate 648) |
ORR in PD-L1 positive: 35% ORR overall: 28% Median OS in PD-L1 positive: 13.7 months Median OS overall: 12.7 months 12-month OS rate in PD-L1 positive: 57% Median PFS in PD-L1 positive: 4.0 months Median PFS overall: Not tested Grade 3–4 AEs: 32% |
Doki et al., 2022 (136) |
| Advanced ESCC | Durvalumab + tremelimumab | 59 | Phase 1, NCT01938612 |
ORR overall: 20.3% ORR in PD‐L1 TC ≥ 25%: 50% ORR in PD‐L1 TC < 25%: 12.2% ORR in PD-L1 TC ≥ 1%: 24.2% ORR in PD-L1 TC < 1%: 6.3% Median PFS: 2.9 months Median OS: 7.9 months 12-month OS rate: 35.3% Grade ≥ 3 AE: 13.6% |
Doki et al., 2022 (137) |
AE, adverse event; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; TC, tumor cells.