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104 reviewsAdding a PD-1/PD-L1 inhibitor to gemcitabine plus cisplatin (GemCis) has shown survival benefits in advanced biliary tract cancer(BTC). Dual inhibition of PD-1/PD-L1 and TIGIT may act synergistically, and further enhance antitumor effects. ZSAB-TOP was a single-arm, multicenter, phase 2 study (NCT05023109) evaluating efficacy and safety of first-line tislelizumab (a PD-1 inhibitor) plusociperlimab (a TIGIT inhibitor) and GemCis in advanced BTC. Eligible patients received tislelizumab (200 mg) and ociperlimab(900 mg) on day 1 until unacceptable toxicity or disease progression, in combination with cisplatin (25 mg/m²) and gemcitabine(1000 mg/m²) on days 1 and 8 of a 21-day cycle for a maximum eight cycles.
The primary endpoint was confirmed objective1234567890();,:response rate (ORR) evaluated by the investigator, which was compared with a historical ORR of 25% with GemCis, with a statistical superiority setting at p ≤ 0.05. From March 8, 2022, to January 18, 2023, 45 patients were enrolled.
Among the 41 patients in the efficacy analysis set, the confirmed ORR was 51.2% (95% CI 35.1–67.1), achieving the statistical superiority criteria (p = 0.0003).Patients who had TIGIT+/PD-L1+ (n = 16) tended to have a numerically greater confirmed ORR (75.0% [95% CI 47.6–92.7]). After amedian follow-up of 14.6 months, median progression-free survival was 7.7 months (95% CI 6.0–9.4), with a median overall survival of 17.4 months (95% CI 11.7-not reached).
Treatment-related adverse events of grade ≥3 occurred in 60.0% of patients; immunemediated adverse events of any grade was observed in 42.2%, with the majority being grade 1 or 2. In conclusion, first-linetislelizumab and ociperlimab plus GemCis yielded clinically promising tumor response and survival outcomes in advanced BTC and were generally well tolerated without new safety signals.
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