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

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  • AbbVie Inc (NYSE: 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.

  • Price Action: ABBV shares are up 1.01% at $113.50 during the market session on the last check Monday.

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