Innate Pharma SA announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Phase 3 confirmatory trial protocol dubbed TELLOMAK 3 for Lacutamab in cutaneous T-cell lymphomas (CTCL), enabling the study to proceed without further comments. The open-label, randomized trial will evaluate lacutamab in two independent cohorts one involving patients with Sézary syndrome treated previously with Mogamulizumab (randomised 1:1 to lacutamab or Romidepsin) and the other involving patients with Mycosis fungoides (randomised 1:1 to lacutamab or Mogamulizumab). The primary endpoint for both cohorts is progression-free survival (PFS) assessed by blinded central review. Innate Pharma cited encouraging Phase 2 data for TELLOMAK showing durable activity, a favorable safety profile and improvements in quality of life and noted that the FDA had given preliminary encouraging feedback on a potential accelerated approval pathway in Sézary syndrome.
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As Jonathan Dickinson, Chief Executive Officer of Innate Pharma, commented: “This regulatory milestone achieved with the FDA is a key landmark for the lacutamab programme. Backed by strong Phase 2 data, it brings us closer to our next goal: submitting an accelerated approval application for Sézary syndrome when the Phase 3 trial is underway.” Meanwhile, Sonia Quaratino, the company’s Chief Medical Officer, added: “We are pleased to have reached this important step for the lacutamab programme as we prepare for initiation of the Phase 3 confirmatory trial, TELLOMAK 3. The efficacy and tolerability data from the Phase 2 TELLOMAK study suggest lacutamab could transform the management of CTCL, an orphan disease with high unmet medical need. Our experienced clinical team looks forward to collaborating with specialised investigators and regulatory authorities to initiate the study in a timely manner.” Innate Pharma plans to launch TELLOMAK 3 in the first half of 2026, building on prior regulatory designations including the FDA’s Fast Track and Breakthrough Therapy statuses and the European Medicines Agency’s PRIME designation and positioning lacutamab as a first-in-class anti-KIR3DL2 antibody in CTCL.