FDA Places Partial Clinical Hold on Trials Examining Eprenetapopt/Azacitidine for Myeloid Malignancies

FDA

The FDA has placed a partial clinical hold on clinical trials examining the combination of eprenetapopt and azacitidine in patients with myeloid malignancies, according to an announcement from Aprea Therapeutics, Inc.¹

The hold does not apply to the biopharmaceutical company’s ongoing clinical trials that are examining the agent in patients with lymphoid malignancies and solid tumors, nor does it apply to the APR-548 trial (NCT04638309).

In the myeloid malignancy programs, about 20 patients are receiving the combination; this includes those with myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), as well as those who are receiving the regimen in the post-transplant maintenance setting. All these trials have completed enrollment.

Notably, patients on these trials who are still deriving benefit from the doublet can continue to receive the treatment on the study. However, as part of the hold, no additional patients can be enrolled to these trials until the hold has been lifted by the FDA.

Aprea Therapeutics, Inc. shared that they will be working closely with the regulatory agency to examine the existing data and address questions raised to resolve the hold as rapidly as possible.

“Patient safety is our highest priority,” Christian S. Schade, chairman and chief executive officer of Aprea Therapeutics, Inc., stated in a press release. “Based on the totality of the data we have for eprenetapopt, we believe that it continues to be a promising therapeutic option for cancer patients. We are working closely with the FDA to review the data specific to eprenetapopt with azacitidine in our myeloid malignancy trials and will provide an update when we have additional information.”

Reference

Aprea Therapeutics announces a partial clinical hold on myeloid malignancy programs. News release. Aprea Therapeutics, Inc. August 5, 2021. Accessed August 6, 2021. https://bit.ly/3CsAyea