AdvanTIG-202: Phase 2 open-label, two-cohort multicenter study of ociperlimab plus tislelizumab and tislelizumab alone in patients with previously treated recurrent or metastatic cervical cancer
- PMID: 40411966
- DOI: 10.1016/j.ygyno.2025.04.579
AdvanTIG-202: Phase 2 open-label, two-cohort multicenter study of ociperlimab plus tislelizumab and tislelizumab alone in patients with previously treated recurrent or metastatic cervical cancer
Abstract
Objective: Investigate the efficacy/safety of ociperlimab (anti-TIGIT monoclonal antibody [mAb]) + tislelizumab (anti-PD-1 mAb) in recurrent/metastatic (R/M) cervical cancer (CC).
Methods: Patients had R/M CC, received ≥1 prior chemotherapy, and were not amenable to curative treatment. In stage 1, 80 patients were randomized 1:1 to ociperlimab 900 mg + tislelizumab 200 mg every 3 weeks (cohort 1) or tislelizumab monotherapy (cohort 2). In stage 2, 98 additional patients were enrolled in cohort 1. Primary endpoint was blinded independent review committee-assessed objective response rate (ORR) by RECIST v1.1 for PD-L1+ subgroup and all-comers in cohort 1.
Results: Between March 2 and December 15, 2021, 178 patients were enrolled, and all were treated (cohort 1: 138; cohort 2: 40). ORR of cohort 1 PD-L1+ subgroup and all-comers were 27.4% (95% CI 18.2%-38.2%) and 23.2% (16.4%-31.1%), respectively. In cohort 1, median progression-free survival (PFS) was 3.0 months (95% CI 2.6-4.9) (all-comers) and 4.1 months (95% CI 2.7-6.9) (PD-L1+); median overall survival was 12.2 months (95% CI 9.9-16.6) (all-comers) and 16.4 months (95% CI, 10.4 months-not estimable) (PD-L1+). 70.3% of cohort 1 had ≥1 treatment-related adverse event (TRAE); 18.1% experienced ≥1 grade ≥3 TRAE. Immune-mediated AEs occurred in 35.5% of cohort 1.
Conclusions: In patients with R/M CC who had received prior chemotherapy, ociperlimab + tislelizumab has promising antitumor activity in both all-comers and PD-L1+ subgroup, supporting further investigation of immune-modulating agent combinations for R/M CC.
Trial registration: ClinicalTrials.gov Identifier: NCT04693234; https://clinicaltrials.gov/study/NCT04693234?term=NCT04693234&rank=1; EudraCT: https://eudract.ema.europa.eu/2020-004657-77.
Keywords: Cervical cancer; Ociperlimab; PD-L1; TIGIT; Tislelizumab.
Copyright © 2025. Published by Elsevier Inc.
Conflict of interest statement
Declaration of competing interest Dr. J-Y Lee reports payment or honoraria for lectures/presentations/speakers bureaus/manuscript writing/educational events (AstraZeneca, Eisai, MSD, Roche, and Takeda), consulting fees (AstraZeneca [DP-02], CanariaBio [FLORA-5], Genmab [GEN1046‐05], GII [GI-101], ImmunoGen [MIRASOL], Merck [DDriver302], MSD [MK4830‐002], Seagen [SGNTV-03], and Sutro [REFRaME-01]), and J-Y Lee’s institution received grants/contracts (Advenchen, Alkermes, Ascendis Pharma, AstraZeneca, BeiGene, BerGenBio, BMS, CanariaBio, Cellid, Clovis Oncology, Corcept, CVK, Eisai, Genemedicine, Genmab, GII, GSK, ImmunoGen, Janssen, Merck, Mersana, MSD, Novartis, Onconic Therapeutics, OncoQuest, ONO, Regeneron, Roche, Seagen, Sutro, Synthon, and Takeda). J-Y Lee also received support from BeiGene pertaining to the present manuscript. Dr. D. Wang is employed by a for-profit health care company (Liaoning Cancer Hospital, China). Drs K. Wang, Y. Gao, and X. Mu are employed by BeiGene and may hold stock or other ownership. Drs S. Boonyapipat, G. Yuan, H.S. Kim, J-W Lee, L. Wang, T. Wang, D. Yao, H. Liu, C-L Chang, T. T. Andabekov, X. Zhang, W. Wang, Y.M. Kim, I. V. Sinielnikov, and L. Wu have no conflicts to disclose.