FDA Places Partial Clinical Hold on AbbVie’s Venclexta-Based Multiple Myeloma Trial

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Shares of AbbVie have slipped a fraction this morning after the company announced the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on all trials evaluating Venclexta (venetoclax) for the investigational treatment of multiple myeloma.

AbbVie said the partial clinical hold follows a review of data from the ongoing Phase 3 BELLINI trial, which is a study in relapsed/refractory multiple myeloma. In that study, AbbVie said a higher proportion of deaths was observed in the venetoclax arm compared to the control arm of the trial. According to data provided by AbbVie, 41 of the 194 patients who were on the venetoclax arm of the trial died. Of those, 13 were considered treatment emergent. Of the 13 treatment-emergent deaths in the venetoclax arm, AbbVie said eight were attributed by the investigator to an event of infection, and more than half were in the setting of refractory or progressive disease. There were 11 patients on the placebo arm that died during the course of the trial. Of those deaths, one was considered treatment emergent. The incidence of grade 3-5 toxicity and serious adverse events was similar between the two arms. The incidence of infections was also similar.

As a result of this action from the FDA, no new patients should be enrolled in any studies of venetoclax for multiple myeloma until a further analysis of the data is completed. Patients who are currently enrolled in studies and receiving benefit from the therapy may continue with treatment, after consultation with their physician. Venetoclax is being developed by AbbVie and Roche’s subsidiary, Genentech.

Venetoclax, sold as Venclexta and Venclycto, 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. In November, Venclexta was approved for the treatment of newly-diagnosed acute myeloid leukemia in adults who are age 75 years or older or who cannot tolerate intensive chemotherapy. The drug has also been approved for certain patients who have been diagnosed with chronic lymphocytic leukemia and small lymphocytic lymphoma.

The FDA’s partial clinical hold does not impact any approved indications for venetoclax, such as chronic lymphocytic leukemia (CLL) or acute myeloid leukemia (AML). The partial hold is limited to the company’s investigational clinical trials in multiple myeloma. AbbVie said it remains confident in the benefit/risk profile of venetoclax in those approved indications.

Michael Severino, AbbVie’s president and vice chairman, said the company is analyzing the results observed in the BELLINI trial and will work with the FDA and other regulatory agencies to determine the next appropriate steps for venetoclax in multiple myeloma. Additional analyses are ongoing, and data will be published in a peer-reviewed journal and/or presented at a future medical meeting.

“We will continue to further the research and development of venetoclax and other therapies with the potential to transform the standards of care in blood cancers,” Severino said in a statement.

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