Innate to begin with TELLOMAK 3

Announcement

Innate Pharma SA proudly declared that they have received clearance by the US Food and Drug Administration (FDA) for the confirmatory Phase 3 protocol for lacutamab in cutaneous T-cell lymphomas (CTCL), undoubtedly with the green signal to proceed with the trial.  The TELLOMAK 3 is a purpose-built confirmatory phase 3 trial, a randomised open-label study engineered to show the efficacy of lacutamab in patients group having Mycosis fungoides and Sezary syndrome who faced failure in offering before-line of systemic therapy.

TELLOMAK 3 trial insight

The trial will involve two independent cohorts presenting enrolment of patients group with Sezary syndrome post-mogamulizumab treatment, generalising a 1:1 ratio to consume romidepsin or lacutamab. Another cohort, enrol patient group with Mycosis fungoides generalising 1:1 same ratio to receive mogamulizumab or lacutamab. The initial endpoint of the study in both the cohorts is the commendable progression-free survival (PFS), analysed by blinded central review.

The previous data from the Phase 2 TELLOMAK trial in CTCL showed a durable activity, improvement and a favourable safety profile in patients’ precious lives. The feedback from the FDA has stimulated the company’s confidence, and now the company is succeeding towards the efforts of the confident Phase 3 TELLOMAK 3 trial in H1 2026. The FDA's empowering feedback on the company’s proposed regulatory pathway effectively involved the leveraged approval for Sezary syndrome, after the phase 3 trial begins.

Statements from the healthcare leaders

The Chief Executive Officer of Innate Pharma, Jonathan Dickinson, said, “This major regulatory milestone with the FDA represents an important step towards the lacutamab program. Standing tall on comprehensive Phase 2 data from TELLOMAK, this clearance gets us a step closer to achieving our next goal, which is submission for leveraged approval in Sezary syndrome, on the phase 3 trial start. We stay dedicated to enhancing this classified therapy for CTCL patients. Alongside making space for worthy value for our shareholders.”

The Chief Medical Officer of Innate Pharma, Sonia Quaratino, said, “We are grateful to achieve this milestone for the lacutamab program as we are getting ready to proceed with a confirmatory Phase 3 study, TELLOMAK 3. The safety and efficacy data from the TELLOMAK Phase 2 trial show the potential of lacutamab and title it as a game changer in the CTCL treatment, an orphan disease with limited treatment. Our expert clinical team will partner with CTCL regulators and investigators to begin with the Phase 3 trial.”