AbbVie's Ibrutinib/Venetoclax Combo Potentially Chemo-free, Fixed-Duration Treatment Option in Leukemia

AbbVie Inc ABBV has announced new data from the Phase 2 CAPTIVATE (PCYC-1142) study evaluating Imbruvica (ibrutinib) combined with Venclexta/Venclyxto (venetoclax) for untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting.
The ibrutinib and venetoclax cohort met its primary endpoint of complete response (CR) rate of 56% among patients without del(17p), 70 years old or younger, and 27.9 months of follow-up.
This rate was higher than the 37% minimum meaningful rate study assumption.
The CR rate was consistent across all patients in the study, including high-risk CLL patient groups.
Furthermore, 24-month progression-free survival (PFS) and overall survival (OS) were 95% and 98%, respectively.
Undetectable minimal residual disease was achieved in 77% of patients in peripheral blood and 60% of patients in the bone marrow.
The most common grade 3/4 adverse effects were neutropenia (33%), hypertension (6%), and neutrophil count decreased (5%).
Adverse events led to the discontinuation of ibrutinib in 4% and venetoclax in 2% of patients.
The safety profile of the combination was generally consistent with known AEs for each agent, and no new safety signals were identified.
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