FDA Places Partial Hold on Patient Enrollment in Innate’s Study in Rare Hematologic Disorder

Rare Daily Staff

The U.S. Food and Drug Administration) has placed a partial clinical hold on Innate Pharma’s lacutamab application to begin human clinical trials leading to a pause in new patient enrollment to the company’s ongoing lacutamab trials.

The partial clinical hold follows one fatal case of hemophagocytic lymphohistiocytosis (HLH), a rare hematologic disorder. Patients already on study treatment who are deriving clinical benefit may continue treatment after being reconsented.

TELLOMAK, Innate Pharma’s ongoing phase 2 trial of lacutamab in cutaneous T-cell lymphoma (CTCL), completed enrollment in the second quarter of 2023. Enrollment is also completed to the initial cohort of the phase 1b PTCL trial and is awaiting a futility interim analysis to progress to the next stage. Innate Pharma is on track for final data from the phase 2 TELLOMAK trial and preliminary data on PTCL in the fourth quarter of 2023.

“Patient safety is of paramount importance to us, and we are currently undertaking efforts to address the FDA requests, which include incorporation of risk mitigation and management strategies for hemophagocytic lymphohistiocytosis in ongoing lacutamab studies.” said Mondher Mahjoubi, CEO of Innate Pharma. “Additionally, with all patients recruited into the phase 2 TELLOMAK study, we do not currently anticipate any delay for the TELLOMAK phase 2 final data due shortly.”

Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell lymphoma, an orphan disease, and peripheral T cell lymphoma. Rare cutaneous lymphomas of T lymphocytes have a poor prognosis with few efficacious and safe therapeutic options at advanced stages.

KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65 percent of patients across all CTCL subtypes and expressed by up 90 percent of patients with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It is expressed by up to 50 percent of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL). It has a restricted expression on normal tissues.

Lacutamab has been granted European Medicines Agency PRIME designation and FDA Fast Track designation for the treatment of patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies. Lacutamab was granted orphan drug status in the European Union and the United States for the treatment of CTCL.

The phase 1b clinical trial is investigating lacutamab monotherapy in KIR3DL2-expressing patients with relapsed/refractory PTCL who have received at least one prior systemic therapy. The trial is designed to evaluate safety, as well as characterize clinical outcomes, pharmacokinetics, and immunogenicity of lacutamab alone in PTCL. Further expansion will be determined based on preliminary efficacy signals.

Photo: Mondher Mahjoubi, CEO of Innate Pharma