KEY TAKEAWAYS
- The phase 2 trial aimed to investigate the efficacy and safety of TIS in combination with investigational agents in pts with R/M HNSCC.
- The primary endpoint was to determine ORR, and the secondary endpoint included PFS, DOR, CBR, & DCR.
- Researchers noticed promising results in the ongoing study; further information will be provided later.
Head and Neck Squamous Cell Carcinoma (HNSCC) ranks as the 7th most prevalent global cancer (Sung et al, CA Cancer J Clin 2021;71:209–249), with Anti-programmed cell death-protein 1 (PD-1) therapy demonstrating improved overall survival (OS) over cetuximab + chemotherapy (CT) in first-line (1L) treatment for PD-L1-positive recurrent/metastatic (R/M) HNSCC. Despite this, not all patients exhibit responsiveness to single-agent anti-PD-1 therapy, necessitating the exploration of novel agents targeting distinct pathways to enhance efficacy. Tislelizumab (TIS), an approved anti-PD-1 monoclonal antibody (mAb) in China, serves as the focal point in this Phase 2 study.
Kevin J. Harrington and his team aim to evaluate the efficacy and safety of TIS in combination with investigational agents—BGB-A425 (targeting TIM-3) and/or LBL-007 (targeting LAG-3)—as 1L treatment for patients with R/M HNSCC.
They will perform an inclusive analysis at (77 sites; 14 countries), enrolling approximately 160 patients (40 per arm) aged ≥18 with immunotherapy-naïve, PD-L1 (combined positive score [CPS] ≥1) R/M HNSCC of the oropharynx, oral cavity, hypopharynx, or larynx, who are not candidates for local/curative therapy and have ≥1 measurable lesion (per RECIST v 1.1). Randomization 1:1:1:1 (stratified by PD-L1 CPS (1–19 vs ≥20) allocated patients to TIS monotherapy, TIS + BGB-A425, TIS + LBL-007, or TIS + BGB-A425 + LBL-007.
TIS 200 mg, BGB-A425, and LBL-007 will be administered via separate intravenous infusions every 3 weeks for up to 2 years or until disease progression, intolerable toxicity, withdrawal of informed consent, or other discontinuation events. The primary endpoint will be assessed by investigators using RECIST v1.1, which is the confirmed objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), duration of response (DOR), clinical benefit rate (CBR), and disease control rate (DSR) (all per investigator; RECIST v1.1), along with safety, OS, and immunogenicity to study drugs. Additionally, ongoing enrollment is in progress, and results are yet to be presented.
The study is sponsored by BeiGene
Source: https://cslide.ctimeetingtech.com/immuno23hybrid/attendee/confcal/show/session/34
Clinical Trial: https://clinicaltrials.gov/study/NCT05909904
Harrington K J, et al. (2023). “TiP – BGB-HNSCC-201 (NCT05909904): Phase 2, Open-Label, Multi-Arm, Global Study of Tislelizumab (TIS) + Investigational Agents as First-Line (1L) Treatment in Patients (Pts) With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC).” Presented at ESMO IO 2023 (Abstract 117).
