NORTH CHICAGO - AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new data from the Phase 2 CAPTIVATE (PCYC-1142) clinical trial,1 evaluating IMBRUVICA (ibrutinib) in combination with VENCLEXTA/VENCLYXTO (venetoclax) in previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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 Leukemia & Lymphoma Society, MRD refers to the small number of cancer cells that remain in the body after treatment. The number of remaining cells may be so small that they do not cause any physical signs or symptoms and often cannot even be detected through traditional methods. Doctors use MRD to measure the effectiveness of treatment and to predict which patients are at risk of relapse.

'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 Constantine Tam, M.D., Hematologist and Disease Group Lead, Low Grade Lymphoma and CLL at Peter MacCallum Cancer Centre, Victoria, Australia, and lead study investigator of CAPTIVATE. 'We are encouraged by these data and the potentially potent combination of ibrutinib plus venetoclax treatment for CLL and potentially other blood cancers in the future.'

The data were presented today during an oral presentation session at the 2019 American Society of Hematology (ASH) Annual Meeting (abstract #35). Results from the MRD-guided, randomized treatment discontinuation cohort and fixed duration cohort of the CAPTIVATE clinical trial are currently being evaluated and will be presented at a future medical meeting.

'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 Mohamed Zaki, M.D., Ph.D., Head of Hematology Oncology, AbbVie. 'We are pleased with the results from this CLL treatment combination and look forward to sharing additional analyses in the future.'

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 Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.

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 Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers.

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: Saturday, December 7 at 8:30 a.m. EST

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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