The US Food and Drug Administration (FDA) has put a partial clinical hold on Innate Pharma’s lacutamab investigational new drug (IND).
As a result, France-based Innate has stopped new patient enrollment in the Phase II TELLOMAK trial in cutaneous T-cell lymphoma (CTCL) and the Phase Ib trial in peripheral T-cell lymphoma (PTCL).
According to the announcement, the FDA put a partial hold on the drug following a participant’s death due to haemophagocytic lymphohistiocytosis (HLH). HLH is a severe systemic inflammatory syndrome which can lead to death.
Innate announced that participants who have already been treated with lacutamab and are receiving clinical benefit may continue the treatment after reconsenting.
Innate’s CEO Mondher Mahjoubi said: “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 haemophagocytic lymphohistiocytosis in ongoing lacutamab studies.”
The Phase II open-label trial (NCT03902184) is investigating lacutamab as a single agent in patients with Sézary syndrome and mycosis fungoides (MF). The primary endpoint is measuring the objective response rate (ORR).
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According to the announcement, the Phase II trial was fully enrolled before the partial clinical hold. According to ClinicalTrials.gov, the trial enrolled 170 patients. Mahjoubi said that the company is still on track with the final data readout in Q4 2023. Innate first reported data from this trial in September 2022.
The Phase Ib PTCL trial completed the initial cohort enrollment of 20 patients. The study is awaiting a futility interim analysis before progressing to the next stage with preliminary data expected in Q4 2023.
Hiccups in Phase II TELLOMAK trial
This is not the first time the TELLOMAK trial has faced issues. In December 2019, Innate announced quality issues related to the chemistry, manufacturing and controls (CMC) process of lacutamab. The company stopped the administration of the drug to new patients but continued to treat enrolled patients in the trial except in sites based in Italy due to trial suspension.
In January 2020, the FDA placed a partial clinical hold with no new patients to be enrolled until a new batch of lacutamab is Good Manufacturing Practice (GMP)-certified and available. UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) allowed for the trial to continue with then-available supply.
Also in January, the French National Agency for Medicines and Health Product Safety (ANSM) allowed to resume the recruitment of Sézary syndrome and MF patients due to unmet needs. In June 2020, the FDA lifted the partial clinical hold based on a quality assessment of the new GMP-certified batch of lacutamab.