744MO AdvanTIG-202: Phase II randomized, multicenter, open-label study of tislelizumab (TIS) with or without ociperlimab (OCI) in patients (pts) with previously treated recurrent/metastatic (R/M) cervical cancer (CC)

Pts with R/M CC have poor prognoses with high unmet clinical needs and few treatment (tx) options. Dual targeting of solid tumors with anti-T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT) and anti-PD-1 mAbs enhances antitumor activity in preclinical studies and clinical studies of other tumors. AdvanTIG-202 (NCT04693234) is investigating the efficacy and safety of TIS (anti-PD-1 mAb) ± OCI (humanized Fc-intact IgG1 anti-TIGIT mAb) in pts with R/M CC. Primary analysis results are reported here. Eligible pts with R/M CC had received ≥1 line of chemotherapy and were not amenable to curative tx. In Stage 1, 80 pts were randomized (1:1) to receive 200 mg TIS IV Q3W + 900 mg OCI IV Q3W (Cohort [C]1) or TIS monotherapy (C2) until disease progression, unacceptable toxicity, or withdrawal of consent. In Stage 2, C1 enrolled 98 additional pts. Primary endpoint: ORR per RECIST v1.1 by IRC for C1. Secondary endpoints: DoR, PFS, OS, and safety. As of June 16, 2022, 138 pts were enrolled and treated in C1 (median age 53.0 y); median study follow-up: 7.4 mo. In the safety analysis set (SS), the ORR was 22.5%, with 13 complete responses (CR; Table); 76.8% had a durable response of ≥6 mo. ORR was 26.2% in pts with PD-L1+ tumors (PD-L1 score ≥5%), with 10 CRs. Both analysis sets showed significant improvement in ORR vs historical control ORR of 15% in pts treated with anti-PD-1 therapy (P<0.05). Around 67% of pts experienced ≥1 tx-related adverse event (TRAE). Only 13% of pts experienced ≥grade 3 TRAEs; the most frequently reported were anemia (2%) and rash (1%). With limited enrollment in C2 (n=40), the ORR was 32.5%. Table: 744MOCohort 1Safety analysis seta (n=138)PD-L1 + (n=84)ORR, % (95% CI)22.5 (15.8, 30.3)26.2 (17.2, 36.9)n (%)Complete response Partial response Stable disease Progressive disease Not determined13 (9.4) 18 (13.0) 56 (40.6) 39 (28.3) 12 (8.7)10 (11.9) 12 (14.3) 34 (40.5) 20 (23.8) 8 (9.5)mDoR, mo 95% CINE (5.6, NE)NE (5.6, NE)mPFS, mo 95% CI3.5 (2.6, 4.9)4.2 (2.7, 6.9)mOS, mo 95% CI9.0 (8.1, 10.4)10.4 (8.1, NE)Data cutoff: June 16, 2022. Efficacy assessed by IRC. aPts who received ≥1 dose of any study drug. DoR, duration of response; IRC, independent review committee; m, median; mo, months; NE, not estimable; ORR, objective response rate; OS, overall survival; PFS, progression-free survival. Open table in a new tab . Data cutoff: June 16, 2022. Efficacy assessed by IRC. aPts who received ≥1 dose of any study drug. DoR, duration of response; IRC, independent review committee; m, median; mo, months; NE, not estimable; ORR, objective response rate; OS, overall survival; PFS, progression-free survival. OCI + TIS showed promising antitumor activity and durable responses, regardless of PD-L1 expression, and was well tolerated in pts with previously treated R/M CC.