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Response Rates to Venetoclax Plus Ibrutinib in High-Risk CLL

By: Cordi Craig
Posted: Wednesday, January 29, 2020

Venetoclax in combination with ibrutinib appears to be well tolerated among patients with chronic lymphocytic leukemia (CLL), according to an ongoing phase II study presented at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 358) and published in the journal Blood. Philip A. Thompson, MBBS, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues reported a high likelihood of patients with CLL achieving undetectable minimal residual disease in bone marrow and complete responses within 12 months of beginning the doublet therapy. 

Currently, the researchers have treated 35 patients with high-risk CLL with venetoclax and ibrutinib. The initial report summarized results for the first 26 patients enrolled.

Undetectable minimal residual disease of the bone marrow was achieved in 33% of the patient pool at 6 months and 67% of the patients at 12 months. Prior to receiving venetoclax, none of the patients achieved complete responses. However, 38% of the patients achieved complete responses at 6 months, and 47% of the patients achieved complete responses at 12 months.

The treatment was reported to be generally well tolerated, and no patients developed tumor-lysis syndrome, experienced disease progression, or discontinued therapy. The most frequently reported adverse events included diarrhea, neutropenia, nausea, and fatigue. Severe adverse events were reported in 14 patients and included non-melanoma skin cancer, metastatic melanoma, localized bladder transitional cell carcinoma, metastatic mucinous adenocarcinoma of the lung, pyelonephritis, skin abscess, inadvertent overdose of ibrutinib, and cholecystitis.

“Further follow-up will determine the likelihood of achieving undetectable minimal residual disease at later time points and durability of responses,” the research team concluded.

Disclosure: For full disclosures of the study authors, visit ashpublications.org.



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