Innate Pharma's Lacutamab Shows Promising Long-Term Results in Lymphoma Study

Innate Pharma, a French biotech company, has released long-term follow-up data from its phase 2 TELLOMAK trial, demonstrating sustained clinical activity of lacutamab in patients with two types of lymphoma. The results, which will be presented at the upcoming American Society of Clinical Oncology (ASCO) meeting in Chicago, show improved response rates and duration of response compared to earlier readouts.

Sustained Efficacy in Sézary Syndrome and Mycosis Fungoides

The TELLOMAK study evaluated lacutamab, an anti-KIR3DL2 antibody, in 63 patients with Sézary syndrome (SS) and 107 patients with mycosis fungoides (MF), two forms of cutaneous T-cell lymphoma. Data collected through October 17, 2025, revealed objective response rates (ORR) of 42.9% for SS patients and 19.6% for MF patients, with median follow-up times of 25.1 and 22.1 months, respectively.

These results show improvement over earlier readouts, which reported ORRs of 37.5% for SS patients at around 14 months and 16.8% for MF patients at approximately 12 months. The duration of response also proved promising, with a median of 25.6 months for SS patients and 13.8 months for those with MF.

FDA Breakthrough Therapy Designation and Future Plans

Dr. Sonia Quaratino, Chief Medical Officer at Innate Pharma, highlighted the significance of these results, stating, "The long-term follow-up data from the TELLOMAK clinical study confirms lacutamab's meaningful clinical benefit in Sézary syndrome and mycosis fungoides and were the basis of the FDA Breakthrough Therapy designation."

The company is now preparing for a phase 3 trial in collaboration with health authorities, aiming to bring lacutamab to patients as quickly as possible. Innate Pharma also sees potential for the drug beyond cutaneous T-cell lymphoma, particularly in combination with other anti-lymphoma agents for peripheral T-cell lymphomas.

Safety Profile and Regulatory Hurdles

While specific adverse event rates were not disclosed, Innate Pharma reported that lacutamab was "very well tolerated." This positive safety profile supports further investigation of the drug, especially in combination therapies.

It's worth noting that the TELLOMAK trial faced a temporary setback in 2023 when the FDA placed it on hold following a fatal case of hemophagocytic lymphohistiocytosis in a patient. However, after analysis suggested the death was related to aggressive disease progression rather than lacutamab, the hold was lifted in January 2024, allowing the trial to continue.