The US Food and Drug Administration (FDA) placed a partial clinical hold on the Investigational New Drug (IND) application for lacutamab following one fatal case of hemophagocytic lymphohistiocytosis (HLH) reported in the clinical trial program.
Lacutamab is a first-in-class, anti-KIR3DL2, humanized, cytotoxicity-inducing antibody undergoing evaluation for the treatment of patients with cutaneous T-cell lymphoma (CTCL) and peripheral TCL (PTCL). It was granted the European Medicines Agency PRIME and FDA Fast Track designations for patients with relapsed or refractory Sézary syndrome who have received at least two prior lines of therapy, as well as orphan drug status for CTCL.
Lacutamab T-cell Lymphoma Trial Enrollment Paused
The developer of lacutamab, Innate Pharma SA, announced it would pause new patient enrollment into its ongoing phase II CTCL (TELLOMAK) and phase Ib PTCL (IPH4102-102) studies, and would take steps to meet requests from the FDA, including HLH risk mitigation and management strategies.
The company noted that the TELLOMAK and the PTCL studies have already completed their planned enrollment of 170 and 20 patients, respectively, and stated it did not predict delays in the publication of final data from TELLOMAK and preliminary data from the futility interim analysis of the PTCL study, both planned for fourth quarter in 2023. The PTCL study would then proceed to the next phase with 20 additional patients, and all patients demonstrating a clinical benefit on lacutamab would be able to continue treatment after updating their consent.