Results showed that patients who received up to 12 cycles of the combination regimen achieved high rates of undetectable minimal residual disease (uMRD) in both peripheral blood (PB; 75 percent of patients) and in bone marrow (BM; 72 percent of patients). Safety data were consistent with the known safety profiles of IMBRUVICA and VENCLEXTA/VENCLYXTO used as individual therapies.
According to the
'The oral regimen of ibrutinib alone followed by combined ibrutinib and venetoclax delivered a promising rate of disease clearance in previously untreated patients with CLL, with 75 percent and 72 percent of patients having undetectable disease (MRD) in the blood and bone marrow, respectively,' said
The data were presented today during an oral presentation session at the 2019
'While IMBRUVICA and VENCLEXTA/VENCLYXTO-based treatments are the established standard-of-care for different CLL patients today, an IMBRUVICA plus VENCLEXTA/VENCLYXTO combination treatment could be a new and innovative option for patients, as evidenced by the positive results from the CAPTIVATE clinical trial,' said
IMBRUVICA is a once-daily, first-in-class Bruton's tyrosine kinase (BTK) inhibitor that is administered orally, and is jointly developed and commercialized by
VENCLEXTA/VENCLYXTO is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLEXTA/VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis. VENCLEXTA/VENCLYXTO is being developed by AbbVie and
Abstract #35: Ibrutinib Plus Venetoclax for First-line Treatment of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL): Results from Minimal Residual Disease (MRD) Cohort of Phase 2 CAPTIVATE Study
Oral Presentation:
The Phase 2 CAPTIVATE (PCYC-1142) clinical trial evaluated 164 patients younger than 70 years (median age of 58 years) with previously untreated CLL/SLL. Ninety-two percent of patients (n=151) were randomly assigned to receive IMBRUVICA monotherapy as lead-in treatment for 3 cycles. Following, all patients completed 12 cycles of IMBRUVICA plus VENCLEXTA/VENCLYXTO combination regimen. MRD status was evaluated in PB after 6, 9, and 12 cycles and in BM after 12 cycles of IMBRUVICA plus VENCLEXTA/VENCLYXTO.
Results showed uMRD - defined as less than 1 CLL cell per 10,000 leukocytes (MRD
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