Leukemia: Study yields 'reassuring' safety data for leukemia drug Venclexta

Abstract 7528: Matthew Steven Davids, MD - Presenter


Poster session, Hematologic Malignancies--Lymphoma and Chronic Lymphocytic Leukemia poster session

Monday, June 6, 8 a.m. - 11:30 a.m., Hall A

Venclexta, the recently approved drug for hard-to-treat chronic lymphocytic leukemia (CLL) patients, has significant side effects, but they are manageable and often become less severe as treatment continues, according to a new study.

Venclexta (venetoclax) received Food and Drug Administration approval on April 11 for patients with CLL who have relapsed or not responded to at least one previous therapy, and whose cancer cells lack a piece of a chromosome called 17p. Patients with the 17p deletion have a worse prognosis.

The drug, which targets "survival proteins" cancer cells deploy to escape orders to self-destruct, has been hailed as a welcome new therapy for CLL after producing a high rate of responses, including some complete responses, in a phase 1 clinical trial reported in the New England Journal of Medicine (NEJM).

In a report to be presented at the annual meeting of the American Society of Clinical Oncology in Chicago, Matthew Davids, MD, MMSc, of Dana-Farber summarized Venclexta side effects and safety data on 279 patients, of whom 181 had the 17p chromosome deletion.

Of these, 24 stopped taking the drug because of adverse events, the most common being a low white blood cell count, diarrhea, nausea, anemia, fatigue, and upper respiratory tract infection. There were 11 deaths linked to adverse events. Tumor lysis syndrome (TLS), a complication of therapy where the rapid death of tumor cells causes metabolic disruptions, was observed in 5 patients, but all of these patients were able to safely reach the full dose and none discontinued drug due to TLS. Working closely with Abbvie and other investigators, Davids has helped develop precautionary measures that reduce the risk of life-threatening TLS.

Davids, a medical oncologist in the Division of Hematologic Malignancies at Dana-Farber, who was a leading investigator on the phase 1 first-in-human trial of Venclexta, says the results of the study are "reassuring, in that they look similar in this larger data set to the results we reported in the NEJM.

"One of the most interesting findings is that the rates of adverse events, particularly the hematologic and gastrointestinal toxicities, decrease significantly over time as patients continued on Venclexta. This suggests that the hematological toxicities, specifically, may be more related to prior chemotherapy and the CLL itself, rather than the drug, which over time helps these toxicities to resolve by effectively treating the CLL."

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