Innate Pharma Gets FDA Green Light for Lacutamab Phase 3 Trial

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Prime Highlights:

  • The FDA has approved Innate Pharma’s Phase 3 trial for lacutamab in cutaneous T-cell lymphomas (CTCL), clearing the way for the study to begin.
  • Phase 2 results showed promising effectiveness and safety, bringing the company closer to potential accelerated approval for Sézary syndrome.

Key Facts:

  • The Phase 3 TELLOMAK 3 trial will include two groups: patients with Sézary syndrome and patients with Mycosis fungoides, both having failed at least one prior systemic therapy.
  • The main goal of the trial is to measure progression-free survival (PFS) through a blinded central review, with the trial expected to start in the first half of 2026.

Background:

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) said that the U.S. FDA has finished reviewing its Phase 3 plan for lacutamab in cutaneous T-cell lymphomas (CTCL) and gave approval to proceed with the study.

The Phase 3 trial, called TELLOMAK 3, will test how well lacutamab works in patients with Sézary syndrome and Mycosis fungoides who did not respond to at least one previous treatment. The study will include two groups: one with Sézary syndrome, who will get either lacutamab or romidepsin, and another with Mycosis fungoides, who will get either lacutamab or mogamulizumab.

The main goal is to see how long patients live without the disease getting worse (progression-free survival), as checked by a central review.

Results from the earlier Phase 2 TELLOMAK trial showed lasting effectiveness, a good safety profile, and improvements in patients’ quality of life. Based on the FDA’s feedback, Innate Pharma is planning to begin the Phase 3 trial in the first half of 2026. The FDA also provided positive initial guidance on the approval process, which could allow for faster approval of lacutamab for Sézary syndrome once the trial is underway.

Jonathan Dickinson, CEO of Innate Pharma, said that this milestone is a key advancement for the lacutamab program. He added that the promising Phase 2 results move the company closer to faster approval for Sézary syndrome and emphasized their commitment to helping patients while delivering value to shareholders.

Sonia Quaratino, Chief Medical Officer, added, “Phase 2 results show that lacutamab has the potential to make a real difference in treating CTCL, a rare disease with limited treatment options.””Our clinical team is excited to work with doctors and regulators as we get ready for Phase 3.”

Starting TELLOMAK 3 is an important step for Innate Pharma in bringing new treatments to patients with rare lymphomas, aiming to improve their care and quality of life.