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

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.