Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2023

AdvanTIG-105: Phase 1b Dose-Expansion Study of Ociperlimab + Tislelizumab in Patients With Checkpoint Inhibitor (CPI)-Experienced Advanced Non-Small Cell Lung Cancer (NSCLC) (#186)

Sophia Frentzas 1 2 , Tarek Meniawy 3 , Steven Kao 4 , Jermaine Coward 5 , Timothy Clay 6 , Nimit Singhal 7 , Allison Black 8 , Wen Xu 9 , Rajiv Kumar 10 , Young Joo Lee 11 , Gyeong-Won Lee 12 , Wangjun Liao 13 , Diansheng Zhong 14 , Her-Shyong Shiah 15 , Yuh-Min Chen 16 , Rang Gao 17 , Ruihua Wang 18 , Hao Zheng 19 , Wei Tan 20 , EunKyung Cho 21 , Paul Smart 22
  1. Department of Medical Oncology, Monash Health, Melbourne, VIC, Australia
  2. Department of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia
  3. Department of Medical Oncology, Linear Clinical Research and School of Medicine, University of Western Australia, Nedlands, WA, Australia
  4. Department of Medical Oncology, Chris O'Brien Lifehouse, Sydney, NSW, Australia
  5. Clinical Trials Unit, Icon Cancer Centre, Brisbane, QLD, Australia
  6. Department of Medical Oncology, St John of God Subiaco Hospital, Perth, WA, Australia
  7. Department of Medical Oncology, Royal Adelaide Hospital and University of Adelaide, Adelaide, SA, Australia
  8. Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS, Australia
  9. Department of Medical Oncology, Princess Alexandra Hospital, Brisbane, QLD, Australia
  10. Department of Oncology, New Zealand Clinical Research, Christchurch, New Zealand
  11. Division of Hemato-Oncology, National Cancer Center, Gyeonggi-do, South Korea
  12. Division of Hematology and Oncology, Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsang National University College of Medicine, Jinju, South Korea
  13. Department of Oncology, Nanfang Hospital of Southern Medical University, Guangzhou, China
  14. Department of Oncology, Tianjin Medical University General Hospital, Tianjin, China
  15. Division of Hematology and Oncology, Department of Internal Medicine, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taipei, Taiwan
  16. Department of Chest Medicine, Taipei Veterans General Hospital and National Yang Ming Chiao Tung University, Taipei, Taiwan
  17. Medical Oncology, BeiGene (Shanghai) Co., Ltd., Shanghai, China
  18. Clinical Development, BeiGene (Shanghai) Co., Ltd., Shanghai, China
  19. Biostatistics, BeiGene (USA) Co., Ltd., San Mateo, CA, USA
  20. Clinical Biomarkers, BeiGene (Shanghai) Co., Ltd., Shanghai, China
  21. Division of Oncology, Department of Internal Medicine, Gil Medical Center, College of Medicine, Gachon University, Incheon, South Korea
  22. Beigene, NSW

Aims: 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 has shown promising antitumor activity in solid tumors. Phase 1/1b open-label study AdvanTIG-105 (NCT04047862) assessed safety and preliminary antitumor activity of anti-TIGIT monoclonal antibody (mAb) ociperlimab + anti-PD-1 mAb tislelizumab in patients with advanced solid tumors. During dose-escalation, ociperlimab + tislelizumab was well tolerated, showing antitumor activity, establishing the recommended phase 2 dose (RP2D) of ociperlimab 900mg IV Q3W + tislelizumab 200mg IV Q3W. Here, we report Cohort 5 dose-expansion results.

Methods: Eligible adults had histologically/cytologically confirmed locally advanced or 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 or stable disease. Patients received RP2D ociperlimab + tislelizumab 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 patients were enrolled; 25 were efficacy-evaluable. Median study follow-up was 46.1 weeks (range, 25.4-59.0). Confirmed ORR was 8.0% (95% CI, 1.0-26.0), with 2 patients experiencing partial response. Confirmed DCR was 56.0% (95% CI, 34.9-75.6); median DOR was not reached. Overall, 23 patients (88.5%) experienced ≥1 treatment-emergent adverse event (TEAE), 11 patients (42.3%) experienced Grade≥3 TEAEs, and 9 patients (34.6%) experienced serious TEAEs. The most common TEAEs were fatigue (30.8%) and cough (26.9%). TEAEs leading to treatment discontinuation occurred in 4 patients (15.4%), of which 2 were related to treatment; no TEAEs led to death.

Conclusions: Ociperlimab 900mg + tislelizumab 200mg was generally well-tolerated and showed preliminary antitumor activity in patients with locally advanced/metastatic CPI-experienced NSCLC.