AdvanTIG-202: A phase 2 study investigating anti-TIGIT monoclonal antibody ociperlimab plus anti-PD-1 monoclonal antibody tislelizumab in patients with previously treated recurrent or metastatic cervical cancer.

Authors

null

Lingying Wu

Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China

Lingying Wu , Peng-Hui Wang , Sheng-Yen Hsiao , Chih-Long Chang , Hee Seung Kim , JUNG-YUN LEE , Sang-Young Ryu , Yunxia Zuo , Xiyan Mu , Yujuan Gao , Silu Yang , Jae-Kwan Lee

Organizations

Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China, Taipei Veterans General Hospital, Taipei, Taiwan, Chi Mei Medical Center, Liouying, Tainan, Taiwan, Mackay Memorial Hospital, Taipei, Taiwan, Seoul National University Hospital, Seoul, South Korea, Severance Hospital, Yonsei University Health System, Seoul, South Korea, Korea Institute of Radiological & Medical Sciences, Seoul, South Korea, BeiGene (Shanghai) Co., Ltd., Shanghai, China, BeiGene (Beijing) Co., Ltd., Beijing, China, Korea University Guro Hospital, Seoul, South Korea

Research Funding

Pharmaceutical/Biotech Company
This study was sponsored by BeiGene, Ltd. Medical writing support, under the direction of the authors, was provided by Jessica Jones, PhD, of Ashfield MedComms, an Ashfield Health company, and funded by BeiGene, Ltd

Background: Women with recurrent/metastatic cervical cancer represent a poor prognostic group with high unmet clinical needs. T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibition motif domains (TIGIT) is a co-inhibitory, immune checkpoint receptor expressed on immune cells and upregulated on T-cells and natural killer cells in multiple solid tumors, inhibiting anticancer immune responses. Ociperlimab (BGB-A1217) is a novel, humanized, monoclonal antibody that binds TIGIT with high specificity and affinity, blocking the interaction with its ligands on tumor cells. Tislelizumab is an anti-PD-1 antibody engineered to minimize binding to FcγR on macrophages to abrogate antibody-dependent phagocytosis, a mechanism of T-cell clearance and potential resistance to anti-PD-1 therapy. Preclinical and clinical studies suggest that dual targeting with anti-TIGIT and anti-PD-1 antibodies produces synergistic immune cell activation and enhanced antitumor activity. Methods: AdvanTIG-202 is a Phase 2, randomized, multicenter, open-label study (NCT04693234). Approximately 167 pts with cervical squamous cell or adenosquamous carcinoma or adenocarcinoma, recruited from 100 centers, whose disease progressed on or after ≥ 1 prior line of chemotherapy for recurrent/metastatic disease will be included in this 2-Part study. In Part 1, approximately 80 pts will be randomized (1:1) to either ociperlimab 900 mg intravenously (IV) in combination with tislelizumab 200 mg IV every 3 weeks (Q3W) (Arm 1), or tislelizumab monotherapy 200 mg IV Q3W (Arm 2), until disease progression, unacceptable toxicity, or withdrawal of consent. In Part 2, Arm 1 will be expanded by approximately 87 additional pts whose tumors are evaluable for PD-L1 expression. The primary endpoint is overall response rate (ORR) (RECIST v1.1) assessed by Independent Review Committee (IRC) in Arm 1. Secondary endpoints are investigator-assessed ORR in Arm 2, IRC-assessed and investigator-assessed ORR in Arm 1, IRC-assessed and investigator-assessed duration of response, progression-free survival, time to response, disease control rate, clinical benefit rate and overall survival, cancer-specific health-related quality of life (HRQoL), safety, pharmacokinetics and immunogenicity in Arms 1 and 2. Exploratory endpoints are generic HRQoL and the association of biomarkers with patient prognosis, response or resistance. Clinical trial information: NCT04693234

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Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Cervical Cancer

Clinical Trial Registration Number

NCT04693234

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr TPS5595)

DOI

10.1200/JCO.2021.39.15_suppl.TPS5595

Abstract #

TPS5595

Poster Bd #

Online Only

Abstract Disclosures