FDA Lifts Partial Hold on Lacutamab Clinical Trial Program After Investigation

By Patrick Daly - Last Updated: February 2, 2024

The US Food and Drug Administration (FDA) has lifted the partial clinical hold on the investigational new drug (IND) application for lacutamab following its analysis of a mortality in the TELLOMAK trial, according to Innate Pharma, the manufacturer of the drug.

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Lacutamab is an anti-KIR3DL2 antibody developed to treat patients with cutaneous T-cell lymphoma (CTCL) and peripheral T-cell disease, rare lymphomas that carry a poor prognosis and lack effective therapies. KIR3DL2 is an inhibitory receptor expressed by approximately 65% of all patients with CTCL subtypes, and by up 90% of patients with aggressive CTCL subtypes, especially Sézary syndrome.

The open-label phase II TELLOMAK trial enrolled patients with Sézary syndrome and mycosis fungoides across the United States and Europe. The primary endpoint is objective global response rate, and secondary endpoints include progression-free survival, duration of response, overall survival, quality of life, pharmacokinetics, immunogenicity, and adverse events.

The partial clinical hold was placed on the lacutamab clinical trial program after the death of a patient with Sézary syndrome was initially attributed to hemophagocytic lymphohistiocytosis. After further investigation, the FDA, alongside the program’s steering committee of independent experts, judged the death was not related to lacutamab therapy and lifted the hold.

“We have worked closely with the FDA to diligently resolve the partial clinical hold on the lacutamab IND, which included an in-depth analysis of the fatal case, which was due to progression of an aggressive form of the disease,” said Sonia Quaratino, MD, PhD, Chief Medical Officer at Innate Pharma.

One arm of the study enrolled approximately 60 patients with Sézary syndrome who previously received two lines of systemic therapy, including mogamulizumab. Outcomes with lacutamab monotherapy in this arm could support a dedicated indication for lacutamab, according to Innate Pharma.

“The lacutamab program continues to plan following the publication of the positive Sézary syndrome results at the recent [American Society of Hematology] Annual Meeting [& Exposition]. We now look forward to sharing final data in mycosis fungoides,” Dr. Quaratino added.

Related: Fatal Reaction in Lacutamab Clinical Trial Leads to FDA Partial Hold

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