Innate Pharma SA has declared that the U.S. FDA has initiated a partial clinical hold on the lacutamab IND, causing a halt in enrolling new patients for their current lacutamab studies IPH4102-201 (Phase 2 TELLOMAK) and 102 (Phase 1b PTCL). This decision comes after a death due to hemophagocytic lymphohistiocytosis (HLH), an uncommon blood disorder in oncology. However, patients already receiving the study treatment and witnessing clinical benefits can resume their treatment after giving fresh consent.
Lacutamab is a first-in-class anti-KIR3DL2 humanized antibody that prompts cytotoxicity and is under clinical evaluation for treating cutaneous T-cell lymphoma (CTCL), a rare disease, and peripheral T cell lymphoma (PTCL).
Mondher Mahjoubi, CEO of Innate Pharma, stated that patient safety is their topmost priority. The company is actively working to address the FDA’s concerns, which involve integrating risk management and mitigation approaches for hemophagocytic lymphohistiocytosis in the ongoing lacutamab studies. He further noted that since all participants have been enrolled in the Phase 2 TELLOMAK trial, they do not foresee any impending delays in releasing the final data for this phase.
Source: INNATE PHARMA PROVIDES UPDATE ON LACUTAMAB CLINICAL PROGRAM.
https://www.innate-pharma.com/media/all-press-releases/innate-pharma-provides-update-lacutamab-clinical-program
