- BRUKINSA (zanubrutinib) shows strong efficacy in treating frontline Chronic Lymphocytic Leukemia (CLL) patients.
- High response rates achieved in patients with high-risk genetic markers, including del(17p) mutations.
- Presented findings underscore favorable safety and potential for time-limited therapy.
BeOne Medicines Ltd. (ONC, Financial) unveiled new data from the SEQUOIA Phase 3 trial highlighting the strong performance of BRUKINSA® (zanubrutinib) in treating patients with frontline Chronic Lymphocytic Leukemia (CLL). The findings were presented at the American Society of Clinical Oncology's Annual Meeting, emphasizing the drug's robust efficacy across diverse patient types, particularly those with high-risk genetic profiles.
The SEQUOIA trial, split into various arms, demonstrated that BRUKINSA in combination with venetoclax achieved a 24-month progression-free survival (PFS) rate of 92% among treatment-naïve CLL patients, with an overall response rate (ORR) of 97%. Particularly notable was the high response among patients carrying the del(17p) mutation or pathogenic TP53 mutation, where 94% remained progression-free at the two-year mark.
Findings from Arm D of the study revealed that 88% of high-risk patients treated with the combination regimen remained progression-free at 36 months, showcasing the potential of BRUKINSA as a versatile treatment across the CLL spectrum. Furthermore, the safety profile of BRUKINSA was consistent with previous studies, identifying no new safety signals.
In a separate cohort (Arm C), BRUKINSA as a monotherapy also showed sustained benefits, with 72.2% of patients remaining progression-free at five years. The trial results reinforce BRUKINSA's potential for both continuous treatment and planned breaks, aiding in managing the disease effectively in high-risk patients.
