AbbVie Inc. (NYSE: ABBV) and patients suffering from multiple myeloma have seen some additional bad news. The Food and Drug Administration (FDA) has placed a partial clinical hold on clinical trials evaluating venetoclax for the investigational treatment of multiple myeloma.
A press release by the company indicated that the partial clinical hold is after a data review from the ongoing Phase 3 BELLINI trial in patients with relapsed/refractory multiple myeloma. The data review showed that there was a higher proportion of deaths observed in the venetoclax arm compared to the control arm of the trial. That is never good news for a drug study.
Venetoclax is being developed by AbbVie and by Roche.
According to 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. While this pertains to new patients, those patients already enrolled in studies and receiving benefit from the therapy will be allowed to continue with treatment after consultation with their physicians. AbbVie will work with physicians to proceed as appropriate and in the best interest of each patient who may be receiving benefit from venetoclax and for those patients who elect to continue receiving treatment.
Cancer.Net indicates that multiple myeloma is not a common cancer, but it is the second most common blood cancer after non-Hodgkin lymphoma in the United States. The lifetime risk for multiple myeloma is said to be about 1 in 132, and this year there are expected to be roughly 32,110 adults who will get this diagnosis in the United States.
AbbVie noted that the FDA clinical hold action does not impact venetoclax’s already approved indications for chronic lymphocytic leukemia or acute myeloid leukemia. The drug giant also said that it remains confident in the benefits and risk profile of venetoclax in those approved indications.
In the venetoclax arm of the study, 41 out of 194 (21.1%) deaths were observed. AbbVie indicated that 13 of those were treatment emergent and eight were attributed by the investigator to an event of infection, with more than half in the setting of refractory or progressive disease. In the placebo arm, there were 11 out of 97 (11.3%) deaths.
Michael Severino, M.D., vice chair and president, AbbVie, said:
We are committed to patient safety and are thoroughly analyzing the results observed in the BELLINI trial. We will continue working with the FDA and worldwide regulatory agencies to determine appropriate next steps for the multiple myeloma program. 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.
AbbVie shares were last seen trading down just 0.3% at $80.41, but they had traded as low as $79.95 earlier.
The stock’s 52-week range is $75.77 to $114.15. AbbVie’s shares were down over 11% year to date, compared with about 13% upside in the S&P 500 Index.