Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

Summary

This was a Phase 2 trial evaluating the effectiveness and safety of tislelizumab in participants with relapsed or hard-to-treat classical Hodgkin lymphoma (cHL). Participants were grouped by prior treatments. The main outcome was to assess overall response rate (ORR) across both cohorts. Participants continued receiving the study treatment until their disease got worse, side effects became too severe, or they chose to stop for other reasons.

Timeline

Start

2020-08-20

Primary completion

2022-12-12

Completion

2024-08-29

Outcome

Met primary endpoint

registry NUMBER Total: 64.4 (48.8 to 78.1) Percentage of Participants NCT04318080 ↗

registry p = 0.0044; Z-test 2.62; Binomial Exact Test; note: One-sided p-value based on a binomial exact test comparing observed ORR to historical rate of 45%. NCT04318080 ↗

Publications

• Results Ghesquières H, López-Guillermo A, De la Cruz F, et al. Tislelizumab, an anti-PD-1 antibody, in patients with relapsed/refractory classical Hodgkin lymphoma in TIRHOL BGB-A317-210: a prospective multicenter LYSA phase 2 study conducted in Western countries. Blood. 2023;142(Suppl 1):1717. DOI:10.1182/blood-2023-188545
• Results Ghesquières H, et al. TIRHOL (BGB-A317-210): International Phase 2 Study in Relapsed/Refractory Classical Hodgkin Lymphoma. Presented at: Congrès de la Société Française d'Hématologie (SFH); March 2024; Paris, France.
• Results Ghesquières H, López-Guillermo A, De la Cruz F, et al. Final analysis from the LYSA phase 2 TIRHOL study (BGB-A317-210): tislelizumab in relapsed/refractory classical Hodgkin lymphoma. Presented at: 18th International Conference on Malignant Lymphoma (ICML); June 18-22, 2025; Lugano, Switzerland. https://doi.org/10.1002/hon.70093_130

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tislelizumab	Monoclonal antibody	200 mg	Intravenous

Indications