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ASH 2025 | BGB-16673 in patients with R/R CLL/SLL: updated results from the ongoing Phase I CaDAnCe-101 study

Inhye Ahn, MD, Dana-Farber Cancer Institute, Boston, MA, discusses the updated efficacy and safety results from the relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) cohort of the ongoing Phase I CaDAnCe-101 trial (NCT05006716). This trial is investigating the BTK degrader BGB-16673, and Dr Ahn notes that results in the CLL/SLL cohort have been highly encouraging thus far. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.

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Transcript

The CaDAnCe-101 study investigated a BTK degrader called BGB-16673. The BTK degrader is a novel class of molecule that degrades the target protein, BTK, through the proteasome pathway. And it distinguishes from the conventional kinase inhibitor because a single molecule can degrade multiple BTK targets sequentially as it does not require sustained target binding. And also it can overcome some of the resistance mutations of the kinase inhibitor, notably the BTK mutations...

The CaDAnCe-101 study investigated a BTK degrader called BGB-16673. The BTK degrader is a novel class of molecule that degrades the target protein, BTK, through the proteasome pathway. And it distinguishes from the conventional kinase inhibitor because a single molecule can degrade multiple BTK targets sequentially as it does not require sustained target binding. And also it can overcome some of the resistance mutations of the kinase inhibitor, notably the BTK mutations. So this phase one study enrolled 68 previously treated CLL patients into part one of the study, and we reported that result. 

In terms of the safety, the drug was orally delivered, a pill drug basically, and was very well tolerated in CLL patients. There were three treatment-related treatment discontinuations, which were grade three bleeding, asthenia, and rash. But other than those side effects, most patients tolerated the treatment very well. In terms of the key efficacy data, we observed an 85% response rate in 68 heavily pretreated CLL patients, with the highest response rate being seen in the 200 milligram dose, which was over 93%. So very remarkable, given the median prior line of therapy for these patients was four. And many of them have been previously exposed to multiple kinase inhibitors.

 

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