Updated efficacy and safety results of the Bruton tyrosine kinase (BTK) degrader BGB-16673 in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) from the ongoing phase 1 CaDAnCe-101 study

ASH 2025 CLL/SLL BGB-16673 Oral

Inhye E. Ahn

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This phase 1 study assessed BGB-16673, an investigational drug that degrades the BTK protein, in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who had received multiple prior therapies. Among 66 patients, 86% responded to treatment, including those with high-risk genetic mutations and prior resistance to BTK inhibitors. BGB-16673 has a tolerable safety profile. Treatment-emergent adverse events (TEAEs) of any grade occurring in ≥25% of patients were fatigue, contusion/bruising, diarrhea, and neutropenia. Grade ≥3 TEAEs occurred in 63% of patients. Four patients had TEAEs that led to death (all due to infections), but no deaths were related to treatment. BGB-16673 showed robust and deepening responses, and further studies are ongoing to confirm the potential benefits.

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