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)

Background

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.

Methods

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.

Results

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: 744MO

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.

Conclusions

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.

Clinical trial identification

NCT04693234.

Editorial acknowledgement

This study was sponsored by BeiGene, Ltd. Medical writing support, under the direction of the authors, was provided by Brittany Gifford, PharmD, of MedicalExpressions, an Inizio company, and was funded by BeiGene, Ltd.

Legal entity responsible for the study

BeiGene, Ltd.

Funding

BeiGene, Ltd.

Disclosure

J. Lee: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, MSD, Roche, Takeda; Financial Interests, Personal, Research Funding: AstraZeneca, Clovis Oncology (Inst), Immunogen (Inst), Janssen Oncology (Inst), Merck (Inst), MSD, MSD (Inst), Synthon (Inst). D. Wang: Financial Interests, Personal, Full or part-time Employment: Liaoning Cancer Hospital. Y. Gao: Financial Interests, Personal, Full or part-time Employment: BeiGene, Ltd. X. Mu: Financial Interests, Personal, Full or part-time Employment: BeiGene; Financial Interests, Personal, Ownership Interest: BeiGene. All other authors have declared no conflicts of interest.