Dr Scarfò on the Future of BGB-16673 in Relapsed/Refractory CLL/SLL

“We hope that with additional evidence we can confirm the efficacy and safety of the mechanism of action [of BGB-16673]. [This includes] this specific compound, but also BTK degraders in general.”

Lydia Scarfò, MD, an assistant professor of internal medicine and a consultant hematologist for the Strategic Research Program on CLL at the Università Vita-Salute San Raffaele, discussed future research directions for the BTK degrader BGB-16673 in patients with relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

During the 2025 European Hematology Association Congress, Scarfò presented data from the phase 1 CaDAnCe-101 trial (NCT05006716) which evaluated the safety and efficacy of BGB-16673 in patients with CLL/SLL who received at least 2 prior therapies. Among efficacy-evaluable patients (n = 66), the overall response rate (ORR) was 80.3%, including a complete remission (CR)/CR with incomplete count recovery rate of 3.0%. Notably, patients treated at the 200-mg dose level (n = 16) achieved an ORR of 93.8% with 1 CR. The median time to response was 2.8 months (range, 2.0-10.9).

Scarfò noted that considering the positive findings from CaDAnCe-101, multiple clinical trials are now underway comparing BGB-16673 with standard of care therapies for the treatment of patients with CLL/SLL. In the phase 3 CaDAnCe-302 trial (NCT06846671), BGB-16673 is being compared with investigator’s choice of treatment in patients with CLL/SLL who previously received a BTK inhibitor and a BCL2 inhibitor. In the phase 3 CaDAnCe-303 study (NCT06970743), BGB-16673 is being compared with investigator’s choice of therapy in patients with CLL/SLL who previously received a covalent BTK inhibitor.

Investigators hope that positive findings from these phase 3 studies will eventually lead to the integration of BGB-16673 into the therapeutic armamentarium of CLL/SLL, Scarfò said. Another goal of future study will be to confirm the safety and efficacy of the mechanism of action of BGB-16673 so that it and other BTK degraders can be used for the treatment of patients with CLL/SLL, Scarfò concluded.