The FINANCIAL — AbbVie on December 6 announced the online publication of new data in the New England Journal of Medicine (NEJM) showing some patients with relapsed/refractory chronic lymphocytic leukemia (CLL) treated with venetoclax experienced a response, including complete responses. The article reports data from Arm A of the study, in which all patients had relapsed CLL and more than one-third were refractory to their last treatment. Venetoclax is an investigational, first-in-class, B-cell lymphoma-2 (BCL-2) inhibitor being developed and commercialized by AbbVie and Genentech and Roche.
“Venetoclax is thought to inhibit the activity of BCL-2, an important anti-apoptotic protein,” said Andrew W. Roberts, M.D., Department of Clinical Haematology and BMT, The Royal Melbourne Hospital, Parkville, Australia, and lead author on the NEJM paper. “In this arm of the dose-escalation study, we assessed safety and efficacy measures for venetoclax in patients with relapsed or refractory CLL.”
In arm A of the M12-175 study, venetoclax had an overall response rate of 79 percent (n=92/116) and complete response in 20 percent of patients. Serious adverse events (AEs) occurring in ≥ 2 percent of patients were febrile neutropenia, pneumonia, immune thrombocytopenia, tumor lysis syndrome, diarrhea, fluid overload, hyperglycemia, prostate cancer, pyrexia, upper respiratory tract infection, and viral upper respiratory tract infection. Grade 3 or 4 AEs occurring in ≥ 2 percentof patients were diarrhea, nausea, neutropenia, fatigue, anemia, thrombocytopenia, vomiting and hyperglycemia, according to AbbVie.
“The publication of these data is the culmination of nearly two decades of work by AbbVie scientists who have advanced our understanding of the BCL protein family and its role in certain cancers,” said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. “Results from this Phase 1 study provide important information about how we might treat relapsed/refractory CLL and about the potential of venetoclax to provide responses for patients battling the disease.”
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