Innate Pharma’s lacutamab remains on track as FDA lifts clinical hold

04 Jan 2024
firstwordpharma.com
Clinical ResultPhase 2Phase 3ASH
Innate Pharma started the year with some positive news as the FDA lifted its partial clinical hold on studies of the anti-KIR3DL2 humanised cytotoxicity-inducing antibody lacutamab. “The lacutamab programme continues to plan,” remarked Sonia Quaratino, the company’s chief medical officer.
The FDA placed the hold on lacutamab in October after a patient death in the Phase II TELLOMAK study, which was initially thought to be due to haemophagocytic lymphohistiocytosis. However, Innate said Thursday that the agency removed the hold after it was determined that the fatal case was related to aggressive disease progression and not caused by lacutamab.
TELLOMAK is investigating lacutamab in patients with the cutaneous T-cell lymphoma subtypes Sézary syndrome and mycosis fungoides. At the recent American Society of Hematology (ASH) annual meeting, Innate reported final results from the Sézary syndrome cohort, with lacutamab associated with an objective response rate of 37.5% and median progression-free survival of 8 months.
“We now look forward to sharing final data in mycosis fungoides,” Quaratino said, which is expected shortly. Innate is hoping to seek accelerated FDA approval of lacutamab in Sézary syndrome, with an executive on a recent conference call indicating that the TELLOMAK data, as well as plans for a confirmatory Phase III study, will be discussed with the agency.
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