Abstract 126P
Background
T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT) inhibitor with an anti-programmed cell death protein 1 (PD-1) antibody is a promising combination showing antitumor activity in solid tumors. Phase 1/1b open-label study AdvanTIG-105 assessed safety and preliminary antitumor activity of anti-TIGIT monoclonal antibody (mAb) OCI + anti-PD-1 mAb TIS in pts with advanced solid tumors (NCT04047862). During dose-escalation, OCI + TIS was well tolerated showing antitumor activity, establishing the recommended phase 2 dose (RP2D) of OCI 900mg IV Q3W plus TIS 200mg IV Q3W. We report Cohort 5 dose-expansion results.
Methods
Eligible adults had histologically/cytologically confirmed locally advanced/metastatic CPI-experienced NSCLC for which they received ≤2 prior therapies, including anti-PD-(L)1 in the most recent line, and progressed after complete or partial response (CR or PR) or stable disease. Pts received RP2D OCI + TIS until disease progression, intolerable toxicity or withdrawal of consent. Primary endpoint was investigator-assessed objective response rate (ORR) per RECIST v1.1. Secondary endpoints included disease control rate (DCR), duration of response (DOR) and safety.
Results
As of June 20, 2022, 26 pts were enrolled; 25 were efficacy evaluable. Median study follow-up was 46.1 weeks (range 25.4-59.0). The confirmed ORR was 8.0% (95% confidence interval [CI]: 1.0, 26.0), with two pts experiencing PR, and the confirmed DCR was 56.0% (95% CI: 34.9, 75.6); median DOR was not reached. Overall, 23 pts (88.5%) experienced ≥1 treatment-emergent adverse event (TEAE); 11 pts (42.3%) experienced Grade ≥3 TEAEs and nine pts (34.6%) experienced serious TEAEs. The most common TEAEs were fatigue (30.8%) and cough (26.9%). TEAEs leading to treatment discontinuation occurred in four pts (15.4%), and were related to treatment in two patients, with no TEAEs leading to death.
Conclusions
OCI 900mg + TIS 200mg was generally well tolerated and showed preliminary antitumor activity in pts with locally advanced/metastatic CPI-experienced NSCLC.
Clinical trial identification
NCT04047862.
Editorial acknowledgement
This study was sponsored by BeiGene, Ltd. Medical writing support, under the direction of the authors, was provided by Sophie Cook, PhD, of Ashfield MedComms, an Inizio company, and was funded by BeiGene, Ltd.
Legal entity responsible for the study
BeiGene, Ltd.
Funding
BeiGene, Ltd.
Disclosure
S.C. Kao: Financial Interests, Personal and Institutional, Advisory Board: AZ, Pfizer, Boeringher, Takeda, MSD, BMS, Roche, Specialised Therapeutics; Financial Interests, Personal and Institutional, Other, Honoraria: AZ, Pfizer, Boeringher, Takeda, MSD, BMS, Roche, Specialised Therapeutics; Financial Interests, Personal, Funding: AstraZeneca. J. Coward: Non-Financial Interests, Institutional, Advisory Board: GOG. T.D. Clay: Financial Interests, Personal, Other, Honoraria: Specialised Therapeutics Australia; Financial Interests, Personal, Advisory Board: AstraZeneca, Foundation Medicine; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Writing Engagements: AstraZeneca; Financial Interests, Personal and Institutional, Invited Speaker: MSD; Financial Interests, Personal and Institutional, Principal Investigator: MSD; Financial Interests, Personal and Institutional, Sponsor/Funding: MSD; Financial Interests, Institutional, Principal Investigator: Pfizer, BMS, Amgen, Daiichi Sankyo, AbbVie, Beigene, Immutep, Clovis, Janssen; Financial Interests, Institutional, Other, Honoraria: Amgen; Financial Interests, Personal, Other, Travel / Accommodation Expenses: Astellas. W. Xu: Financial Interests, Personal and Institutional, Advisory Board: Merck ; Financial Interests, Personal and Institutional, Invited Speaker: Merck ; Financial Interests, Personal and Institutional, Research Grant: Merck ; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Invited Speaker: MSD. R. Gao: Financial Interests, Personal and Institutional, Full or part-time Employment: BeiGene, Ltd. R. Wang: Financial Interests, Personal, Full or part-time Employment: BeiGene, Ltd. H. Zheng: Financial Interests, Institutional, Full or part-time Employment: BeiGene USA; Financial Interests, Institutional, Stocks/Shares: BeiGene USA. W. Tan: Financial Interests, Personal and Institutional, Full or part-time Employment: BeiGene, Ltd. All other authors have declared no conflicts of interest.