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Highlights

  • Overall response rate of 42.9% in Sézary syndrome and 19.6% in mycosis fungoides
  • Median duration of response reached 25.6 months in SS, 13.8 months in MF
  • Data support further evaluation of lacutamab in peripheral T-cell lymphomas

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) presented new long-term data from its Phase 2 TELLOMAK trial evaluating lacutamab in Sézary syndrome (SS) and mycosis fungoides (MF) at the ASCO 2025 Annual Meeting. The findings, as of the October 17, 2024 data cut-off, showed durable clinical activity in patients with these advanced forms of cutaneous T-cell lymphoma (CTCL).

Lacutamab, an anti-KIR3DL2 monoclonal antibody, demonstrated an overall response rate (ORR) of 42.9% in patients with SS and 19.6% in MF, conditions characterized by poor prognosis and limited therapeutic options. Importantly, the updated median duration of response extended to 25.6 months for SS and 13.8 months for MF. These data reflect longer-lasting efficacy compared to previous interim analyses.

The treatment continued to show a favorable safety profile, with tolerability supporting its investigation in combination strategies, particularly for peripheral T-cell lymphomas. While the Breakthrough Therapy Designation granted by the FDA for lacutamab in SS acknowledges its clinical promise, no new regulatory filings or commercial timelines were disclosed during the ASCO update.

Principal investigator Prof. Pierluigi Porcu emphasized the clinical relevance of durable responses in heavily pretreated patients, a key consideration given the limited therapeutic landscape. Innate Pharma’s Chief Medical Officer, Dr. Sonia Quaratino, indicated that preparations for a Phase 3 trial are underway, though specific enrollment or launch details remain pending.

The updated TELLOMAK data may influence further study designs and health authority discussions but does not yet change the standard of care. Continued monitoring and additional trials will determine lacutamab’s future regulatory and therapeutic positioning.