DISCLAIMER
The contents of the presentation are designed for educational and scientific exchange purposes and are not promotional. They may contain information on investigational products or investigational uses of approved products. No conclusions regarding safety and/or efficacy for such investigational products or uses may be made.
SUMMARY
This single-arm, multicenter, open-label, phase 2 study evaluated investigational sonrotoclax monotherapy in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) previously treated with chemoimmunotherapy and a Bruton tyrosine kinase (BTK) inhibitor. This analysis reports the updated efficacy and safety results of the study. One hundred patients were enrolled; at baseline, 62.8% had unmutated immunoglobulin heavy chain variable region (IGHV), 38.1% had del(17p)/TP53 mutations, and 25.5% had BTK mutations. At a median follow-up of 28.9 months, 52% of patients remained on treatment; median treatment exposure was 21.9 months. The primary endpoint of independent review committee (IRC)-assessed overall response rate (ORR) was 77.0%, including a complete response rate of 29.0%. IRC-assessed ORR was consistent across subgroups: 75.9% in patients with unmutated IGHV, 70.3% in those with del(17p)/TP53 mutations, and 72.0% in those with BTK mutations. The best peripheral blood undetectable measurable residual disease (MRD) rate was 53.0% in the efficacy-evaluable population (53/100) and 77.9% among patients with evaluable MRD assessments (53/68). Median progression-free survival (PFS), duration of response, and overall survival (OS) were not reached; the 2-year PFS and OS rates were 60.7% (95% CI, 49.7%-69.9%) and 76.3% (95% CI, 66.2%-83.8%), respectively. The most common all-grade/grade ≥3 treatment-emergent adverse events (TEAEs) were neutropenia (60.0%/33.0%), thrombocytopenia (53.0%/13.0%), leukopenia (39.0%/12.0%), and anemia (39.0%/5.0%). Serious TEAEs occurred in 46.0% of patients, and no new grade 5 TEAEs were reported.
ClinicalTrials.gov ID: NCT05479994
