Sellas Life Sciences has reported the multicentre Phase IIa trial data of a highly selective cyclin-dependent kinase 9 (CDK9) inhibitor, SLS009, in treating relapsed/refractory diffuse large B-Cell lymphoma (r/r DLBCL).
Funded and conducted by GenFleet Therapeutics of Shanghai in China, the open-label, single-arm trial assessed the combination of the therapy and Brukinsa (zanubrutinib), a Bruton tyrosine kinase (BTK) inhibitor, and reported an overall response rate of 67%.
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The study enrolled nine subjects with r/r DLBCL, three with germinal centre B cell-like (GCB), and six with activated B cell-like (ABC) DLBCL subtypes.
The median age of subjects was 55 years, with a median of two prior lines of therapy. The ABC subtype also referred to as non-GCB DLBCL is generally associated with a poorer prognosis compared to GCB DLBCL.
In terms of efficacy and safety, four out of the six non-GCB DLBCL subjects achieved an objective response, with one attaining stable disease.
This resulted in a disease control rate of 83%. Among the responders, one achieved a complete response, while three others experienced partial responses with significant target lesion shrinkages.
The median overall survival has not been reached after a median follow-up of 4.6 months, and six subjects were still alive at the last follow-up.
Genetic analysis of six subjects revealed an absence of myeloid differentiation primary response 88 (MYD88) or cluster of differentiation 79B (CD79B) mutations, which are typically predictive of a better response to BTK inhibitors.
Sellas Life Sciences CEO and president Angelos Stergiou said: “These results represent a promising step forward in improving outcomes for DLBCL patients and underscores the potential of SLS009 in combination with zanubrutinib to deliver meaningful clinical benefits.
“Achieving an ORR that significantly exceeds expectations, along with a complete response and multiple partial responses, is a testament to the power of collaboration and innovation in tackling this challenging disease.”
Sellas Life Sciences announced in December 2023 that its Phase I study of galinpepimut-S in combination with Opdivo (nivolumab) met its primary endpoint, demonstrating increased overall survival in mesothelioma patients.
