Università Vita-Salute San Raffaele

Novel BTK Degrader BGB-16673 Achieves 84.8% Response Rate in Heavily Pretreated CLL/SLL Patients

- BGB-16673, a novel BTK protein degrader, demonstrated an 84.8% overall response rate in 66 heavily pretreated patients with relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma in the phase 1/2 CaDAnCe-101 trial. - The treatment showed efficacy across high-risk patient subgroups, including those with BTK mutations and prior exposure to multiple BTK and BCL2 inhibitors, with responses observed regardless of baseline mutations and unfavorable biological features. - At a median follow-up of 15.6 months, the drug was well-tolerated with manageable safety profile, and achieved a one-year progression-free survival rate of 77.4% in this challenging patient population. - The 200-mg dose level, selected for expansion, showed particularly promising results with a 93.8% overall response rate and median duration of exposure of 16.2 months.