Highlights

  • FDA completes review of Innate Pharma’s Phase 3 protocol for lacutamab in CTCL with no further comments.
  • The TELLOMAK 3 trial will include Sézary syndrome and Mycosis fungoides patient cohorts.
  • Phase 2 data showed durable activity and favorable safety profile supporting progression to Phase 3.

Innate Pharma SA (NASDAQ:IPHA) 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). The FDA had no further comments, allowing the trial to proceed.

This clearance represents a significant regulatory milestone for Innate Pharma’s lacutamab program and supports its continued development as a potential treatment for CTCL, a group of rare non-Hodgkin’s lymphomas that affect the skin and can severely impact patients’ quality of life.

TELLOMAK 3 Trial Design and Objectives

The confirmatory Phase 3 study, named TELLOMAK 3, is an open-label, randomized trial designed to evaluate the efficacy of lacutamab in patients with Sézary syndrome and Mycosis fungoides who have failed at least one prior systemic therapy.

The study will consist of two independent cohorts:

  • One cohort will enroll Sézary syndrome patients who have previously received mogamulizumab and will randomize them 1:1 to receive either lacutamab or romidepsin.
  • The second cohort will enroll patients with Mycosis fungoides and randomize them 1:1 to receive either lacutamab or mogamulizumab.

The primary endpoint for both cohorts will be progression-free survival (PFS), evaluated by blinded central review. The company plans to initiate TELLOMAK 3 in the first half of 2026.

Leadership Commentary

“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 once the Phase 3 trial is underway. We remain deeply committed to advancing this differentiated therapy for patients with CTCL, while creating meaningful value for our shareholders.”

“We are pleased to reach this important milestone for the lacutamab program as we prepare to initiate the confirmatory Phase 3 study, TELLOMAK 3,” said Sonia Quaratino, Chief Medical Officer of Innate Pharma. “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, an orphan disease with a high unmet medical need. Our expert clinical team looks forward to collaborating with CTCL investigators and regulators to start the Phase 3 trial in due time.”

About Lacutamab and Next Steps

Lacutamab is a first-in-class anti-KIR3DL2 antibody under development for cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). Data from the Phase 2 TELLOMAK trial demonstrated durable clinical activity, a favorable safety profile, and improved patient-reported outcomes.

Following FDA’s positive feedback, Innate Pharma is moving forward with TELLOMAK 3 and exploring a potential Accelerated Approval pathway for Sézary syndrome once the Phase 3 study is underway.