Dr Mou on the Significance of Efficacy Data for Tacabrutideg in CLL

“As we move away from the era of traditional chemotherapy, it will be important for [the CLL field] to continually re-analyze and weigh the effectiveness of novel therapies against traditionally negatively prognostic risk factors, so this is a promising start.”

Eric Mou, MD, a clinical associate professor of internal medicine-hematology, oncology, and blood and marrow transplantation in the Department of Internal Medicine at the University of Iowa Carver College of Medicine, discussed efficacy data shown for the BTK degrader tacabrutideg (BGB-16673) for patients with BTK inhibitor–naive chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) from the phase 1/2 CaDAnCe-101 trial (NCT05006716), which were presented at the 2026 EHA Congress.

At a median follow-up of 8.2 months (range, 0.4-12.8), data from the trial showed that efficacy-evaluable patients in the CLL/SLL cohort (n = 22) achieved an overall response rate of 86.4%, including best responses of partial response (PR; 68.2%), PR with lymphocytosis (18.2%), and stable disease (SD; 13.6%). Responses were ongoing in all responders as of the data cutoff. Additionally, among patients who were evaluable with 17p deletions or TP53 mutations (n =6), 4 responded, and 2 remained on treatment with SD. All patients with unmutated IGHV (n = 4) experienced responses.

Mou began by noting that due to the small cohort size, drawing conclusions about the superior efficacy with tacabrutideg compared with other agents in the CLL treatment paradigm is difficult. However, he noted that response rates were high at the most recent follow-up and appear to be durable to date. Monitoring the efficacy of tacabrutideg in patients with high-risk features like unmutated IGHV or 17p deletions is critical, he explained. Mou then underscored positive data for tacabrutideg in patients with these high-risk factors.

Mou moved into a discussion about the vast landscape of CLL research, pointing out how the safety and efficacy profiles of tacabrutideg are consistent with those of other novel treatments that are currently in development. Finally, Mou concluded by highlighting the potential of combination regimens that use tacabrutideg and the possibility of tailoring these regimens based on factors like high-risk features.