FDA halts Xencor’s acute myeloid leukaemia trial following two patient deaths
pharmafile | February 21, 2019 | News story | Research and Development | Cancer, FDA, Xencor, leukaemia, pharma
Cancer biopharma firm Xencor has revealed it is to place a hold on its ongoing Phase 1 trial of XmAb14045, its investigational CD123 x CD3 bispecific antibody, in patients with relapsed or refractory acute myeloid leukaemia and other CD123-expressing hematologic malignancies after the deaths of two patients which are considered to be “at least possibly related” to the use of the drug.
The deaths were originally detailed in a safety report submitted by Xencor to the FDA. According to the report, one patient suffered cytokine release syndrome (CRS) after receiving their first dose, and the treatment of this CRS was “complicated” by their decision to withdraw care. The second developed acute pulmonary edema after receiving several doses.
The hold means that no new participants will be admitted to take part in the study, but those currently receiving treatment via the trial will be allowed to continue. The FDA will lift the hold subject to its satisfaction on the safety of the trial, with Xencor required to supply additional data to support this.
“Patient safety is Xencor’s highest concern,” commented Dr Bassil Dahiyat, President and Chief Executive Officer at Xencor. “We are working with the investigators and the FDA and will provide an update when more information about resuming enrolment can be shared. Our ongoing Phase 1 studies evaluating our other CD3 bispecific antibodies, XmAb13676 and XmAb18087, are not affected.”
Matt Fellows
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