FDA Places Clinical Hold on Leukemia Drug

Agency cites serious adverse events in dose-ranging trial

A phase 1, open-label, dose-escalation study of JNJ-63709178 (Janssen/Genmab), an investigational drug for acute myeloid leukemia (AML), has been put on clinical hold because of serious adverse events, according to a report posted on the BioSpace website.

Subjects initially received a 2-mcg/kg intravenous (IV) infusion of the drug. Each subsequent cohort was to receive IV infusions at an increased dose level, which would continue until the maximum tolerated dose was identified or all planned doses were administered. In addition, the subjects were to receive the IV infusion once every two weeks.

In a statement, a Janssen spokesman said: “Janssen R&D temporarily suspended the study on August 8. We’re working with the FDA now to address recommended changes to the study. At this point, we don’t have any additional details to share. We’re hoping to resume the study with appropriate guidance from the FDA.” 

The company offered no information regarding the adverse events that caused the study’s shut-down.

JNJ-63709178, a bispecific antibody, targets both CD3 and CD123. The CD3 complex is a group of proteins on the surface of T cells. CD123 is a tumor-associated antigen (TAA) that is overexpressed on the surface of some tumor cells. The clinical rationale behind the development of JNJ-63709178 is that it would simultaneously bind to both CD3-expressing T cells and CD123-expressing cancer cells.

In July, the FDA granted a breakthrough therapy designation to Janssen/Genmab’s daratumumab (Darzalex), a monoclonal antibody. The treatment is being evaluated in combination with standard of care in patients with multiple myeloma.

Source: BioSpace; September 19, 2016.