China-based Antengene Corporation Ltd (HKG: 6996) has announced a clinical trial collaboration with BeiGene Inc. (Nasdaq: BGNE) to evaluate the combination of Antengene’s selinexor (trade name: Xpovio) with BeiGene’s anti-PD-1 drug tislelizumab (Baizean). The open-label, multi-center Phase I/II trial aims to explore this combination as a potential treatment for patients with T and NK-cell lymphoma.
Trial Details
The collaboration involves testing the combination regimen in an open-label, multi-center Phase I/II clinical trial. This trial will assess the safety, tolerability, and efficacy of the selinexor-tislelizumab combination in patients with T and NK-cell lymphoma, a group of aggressive and often treatment-resistant malignancies. Specific financial terms of the collaboration were not disclosed.
Drug Background
Selinexor, discovered by US-based Karyopharm Therapeutics Inc. (Nasdaq: KPTI), is the world’s first and only FDA-approved oral XPO1 inhibitor, used to treat hematological malignancies. Antengene licensed the rights to selinexor in Greater China, South Korea, and ASEAN countries in May 2018, with the first approval in China granted in November 2021 for relapsed or refractory multiple myeloma (R/R MM). BeiGene’s tislelizumab, an internally developed anti-PD-1 drug, has received nine indication approvals in China, including three for lung cancer and as a third-line treatment for classic Hodgkin’s lymphoma.
Strategic Significance
This collaboration represents a significant step forward in exploring novel treatment options for T and NK-cell lymphoma patients. By combining selinexor’s mechanism of action as an XPO1 inhibitor with tislelizumab’s immune checkpoint inhibition, the trial aims to address an area of high unmet medical need. The results of this Phase I/II study could potentially expand the therapeutic landscape for these challenging malignancies.-Fineline Info & Tech
