Innate Pharma Announces FDA Clearance to Proceed With TELLOMAK 3, a Confirmatory Phase 3 Trial of Lacutamab in CTCL
Innate Pharma S.A. - American Depositary Shares (IPHA)
Company Research
Source: Business Wire
The planned confirmatory Phase 3 trial, TELLOMAK 3, aims to demonstrate efficacy of lacutamab in patients with Sézary syndrome (SS) and Mycosis fungoides (MF), who failed at least one prior line of systemic therapy.The Company submitted the confirmatory Phase 3 TELLOMAK 3 protocol to the FDA, which completed its review with no further comments, clearing the study to proceed.The Company is progressing towards the initiation of the confirmatory Phase 3 TELLOMAK 3 trial in H1 2026 and the potential accelerated approval in SS. MARSEILLE, France--(BUSINESS WIRE)--Regulatory News:Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the confirmatory Phase 3 protocol for lacutamab in cutaneous T-cell lymphomas (CTCL), with no further comments, clearing the trial to proceed.The planned confirmatory Phase 3 trial, TELLOMAK 3, is an open-label, randomized study designed to
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