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ASH 2019: First-Line Ibrutinib and Venetoclax in Previously Treated CLL

By: Cordi Craig
Posted: Monday, December 23, 2019

The combination of ibrutinib and venetoclax seemed to be an effective treatment of previously untreated patients with high-risk chronic lymphocytic leukemia (CLL), according to Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues. Initial results for the first-line cohort were published in The New England Journal of Medicine, and updated data were presented at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida (Abstract 34).

The research team enrolled 80 patients with CLL to receive ibrutinib monotherapy followed by the addition of venetoclax. The investigators assessed responses based on blood, bone marrow, and CT imaging after 3, 6, 9, 12, 18, and 24 cycles of combination therapy.

Overall, five patients discontinued the study prior to beginning venetoclax. During monotherapy, none of the 75 remaining patients achieved undetectable minimal residual disease. However, after 3, 6, and 12 cycles of combination treatment, 16%, 42%, and 65% of patients, respectively, achieved undetectable minimal residual disease status. 

None of the patients experienced disease progression; however, a single patient developed Richter’s transformation and two patients died. Overall, 12 patients withdrew from the study, 5 of whom came off trial during monotherapy. During the combination phase, seven patients withdrew due to recurrent neutropenia (n = 2), diffuse large B-cell lymphoma transformation (n = 1), pneumonia (n = 1), fallopian tube cancer (n = 1), allogeneic stem cell transformation (n = 1), and hemolytic anemia/myelodysplastic syndrome (n = 1).

“Ongoing randomized studies will further help define the role of this combination approach in CLL,” the researchers concluded.

Disclosure: For full disclosures of the study authors, visit ash.confex.com.



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