BeiGene to present new data from SEQUOIA study of BRUKINSA

BeiGene announced the presentation of new data from the SEQUOIA study of BRUKINSA at the European Hematology Association 2024 Hybrid Congress in Madrid, Spain in an oral session. The presentation will feature data from arm D of SEQUOIA evaluating BRUKINSA in combination with venetoclax in treatment-naive patients with high-risk chronic lymphocytic leukemia and/or small lymphocytic lymphoma with del(17p) and/or TP53 mutation. The preliminary data demonstrate that in the 65 response-evaluable patients treated with the combination, the overall response rate was 100%, and the rate of complete response plus CR with incomplete hematopoietic recovery was 48%. The safety profile of the combination is consistent with that of the treatment components, and no new safety signals were seen. Overall, 66 patients with centrally assessed del(17p) and/or TP53 mutation were enrolled in this arm of the SEQUOIA study. Patients received BRUKINSA at 160 mg twice daily for three months, followed by combination treatment of BRUKINSA at the same dose and venetoclax with a ramp-up dosing to 400 mg once daily for 12 to 24 cycles until progressive disease, unacceptable toxicity or confirmed undetectable minimal residual disease. In the 65 response-evaluable patients, ORR was 100%; the rate of CR+CRi was 48%. Undetectable MRD was achieved in 59% of patients in greater than or equal to1 peripheral blood sample and with a median study follow up of 31.6 months. Median progression-free survival was not reached; 12- and 24-month PFS estimates were 95% and 94%, respectively.