A Phase 1/2 study of the PD-L1 inhibitor, BGB-A333, alone and in combination with the PD-1 inhibitor, tislelizumab, in patients with advanced solid tumours
- Author(s)
- Desai, J; Fong, P; Moreno, V; Frentzas, S; Meniawy, T; Markman, B; Voskoboynik, M; Rahman, T; Budha, N; Wu, J; Marlow, J; Yang, S; Calvo, E; Martin-Liberal, J;
- Details
- Publication Year 2023-04,Volume 128,Issue #8,Page 1418-1428
- Journal Title
- British Journal of Cancer
- Publication Type
- Research article
- Abstract
- BACKGROUND: Many patients do not respond or eventually relapse on treatment with programmed cell death protein-1 (PD-1)/programmed death-ligand 1 (PD-L1) checkpoint inhibitors due to secondary or acquired resistance; therefore, there is a need to investigate novel PD-1/PD-L1 inhibitors. METHODS: This open-label, non-randomised study investigated the safety and anti-tumour activity of BGB-A333, a PD-L1 inhibitor, alone and in combination with tislelizumab in patients with advanced solid tumours with progression during/after standard therapy. The primary objectives were to determine the recommended Phase 2 dose (RP2D), safety and tolerability for BGB-A333 alone and in combination with tislelizumab (Phase 1a/1b) and to determine the overall response rate (ORR) with BGB-A333 plus tislelizumab (Phase 2). RESULTS: Overall, 39 patients across Phase 1a (N = 15), 1b (N = 12) and 2 (N = 12) were enroled. In Phase 1a, an RP2D of 1350 mg was determined. In Phase 1a and 1b/2, serious treatment-emergent adverse events (TEAEs) were reported in five and eight patients, respectively. Two patients experienced TEAEs that led to death. In Phase 2, the ORR was 41.7% (n = 5/12; 95% confidence interval: 15.17%, 72.33%). CONCLUSIONS: TEAEs reported with BGB-A333 were consistent with other PD-L1 inhibitors. Encouraging preliminary anti-tumour activity was observed with BGB-A333 in combination with tislelizumab. CLINICAL TRIAL REGISTRATION: NCT03379259.
- Publisher
- Springer Nature
- Keywords
- Humans; *Immune Checkpoint Inhibitors; *B7-H1 Antigen; Programmed Cell Death 1 Receptor; Neoplasm Recurrence, Local/drug therapy; Antibodies, Monoclonal/adverse effects
- Department(s)
- Medical Oncology
- PubMed ID
- 36797356
- Publisher's Version
- https://doi.org/10.1038/s41416-022-02128-3
- Open Access at Publisher's Site
- https://doi.org/10.1038/s41416-022-02128-3
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2023-07-19 07:47:31
Last Modified: 2023-07-19 07:47:59