Innate Pharma Receives FDA Clearance for Phase 3 Trial of Lacutamab in Cutaneous T-Cell Lymphoma
核心洞察
Innate Pharma announced FDA clearance to proceed with TELLOMAK 3, a confirmatory Phase 3 trial of lacutamab in patients with Sézary syndrome (搜索) and Mycosis fungoides (搜索) who failed prior systemic therapy.
The randomized, open-label study will compare lacutamab against standard treatments with progression-free survival as the primary endpoint, targeting trial initiation in H1 2026.
FDA provided encouraging feedback on a potential accelerated approval pathway for Sézary syndrome (搜索) once the Phase 3 trial is underway, building on positive Phase 2 data.
Innate Pharma SA announced that the U.S. Food and Drug Administration has completed its review of the confirmatory Phase 3 protocol for lacutamab in cutaneous T-cell lymphomas with no further comments, clearing the TELLOMAK 3 trial to proceed. The regulatory milestone represents a significant advancement for the first-in-class anti-KIR3DL2 (搜索) antibody in treating rare and aggressive forms of T-cell lymphoma.
Trial Design and Patient Population
The planned confirmatory Phase 3 trial, TELLOMAK 3, is an open-label, randomized study designed to demonstrate the efficacy of lacutamab in patients with Sézary syndrome (搜索) and Mycosis fungoides (搜索) who failed at least one prior line of systemic therapy. The trial will include two independent cohorts: one enrolling patients with Sézary syndrome post-mogamulizumab treatment randomized 1:1 to receive lacutamab or romidepsin, and one enrolling patients with Mycosis fungoides randomized 1:1 to receive lacutamab or mogamulizumab.
The primary endpoint of the study for both cohorts is progression-free survival evaluated by blinded central review. The company is progressing towards the initiation of the confirmatory Phase 3 TELLOMAK 3 trial in H1 2026.
Regulatory Pathway and Accelerated Approval Potential
FDA provided encouraging initial feedback on Innate Pharma's proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome (搜索) once the Phase 3 trial is underway. This pathway builds on data from the Phase 2 TELLOMAK trial in CTCL (搜索) that demonstrated durable activity, a favorable safety profile, and improvements in patients' quality of life.
"This important regulatory milestone with the FDA marks a key step forward for the lacutamab program," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. "Building on robust Phase 2 data from TELLOMAK, this milestone brings us one step closer to our next goal, submitting for accelerated approval in Sézary syndrome (搜索) once the Phase 3 trial is underway."
Disease Background and Unmet Need
CTCL (搜索) is a group of rare non-Hodgkin's lymphomas (搜索) that develop in the skin and severely affect patients' quality of life. Sézary syndrome (搜索) is a rare and aggressive leukemic form with poor survival, while mycosis fungoides (搜索) is the most common subtype, with advanced stages associated with poor outcomes.
Sonia Quaratino, Chief Medical Officer of Innate Pharma, emphasized the therapeutic potential: "The efficacy and safety data from the TELLOMAK Phase 2 trial suggest that lacutamab has the potential to be a game changer in the treatment of CTCL (搜索), an orphan disease with a high unmet medical need."
Drug Profile and Regulatory Designations
Lacutamab is a first-in-class anti-KIR3DL2 (搜索) antibody currently developed in cutaneous T-cell lymphoma (搜索) and peripheral T-cell lymphoma (搜索). The program has received multiple regulatory designations recognizing its therapeutic potential: Fast Track designation from the FDA, PRIME designation from the EMA for Sézary syndrome (搜索), Orphan Drug designation in both the US and EU for CTCL (搜索), and most recently Breakthrough Therapy Designation for Sézary syndrome.
The comprehensive regulatory support reflects the significant unmet medical need in CTCL (搜索) treatment and the promising clinical profile demonstrated by lacutamab in early-phase studies. With FDA clearance now secured, Innate Pharma is positioned to advance this differentiated immunotherapy toward potential market approval for patients with limited treatment options.