TelloMAK results Out

Innate Pharma SA announced the presentation of long-term follow-up data from the Phase II TELLOMAK clinical trial evaluating lacutamab, an anti-KIR3DL2 monoclonal antibody, in patients with Sézary syndrome (SS) and mycosis fungoides (MF), two rare and aggressive forms of cutaneous T-cell lymphoma (CTCL). The results will be presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting, in Chicago, Illinois. Lacutamab was recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Sézary syndrome, underscoring its potential to address critical needs in advanced CTCL.

As of October 17, 2024, data cut-off, lacutamab demonstrated compelling and sustained clinical activity in heavily pretreated patients, with a global ORR of 42.9% for SS and 19.6% for MF. With longer follow-up, we observed improved median duration of response of 25.6 months in SS and 13.8 months in MF, highlighting the durability of responses in these challenging indications. In addition, lacutamab was very well tolerated supporting the strong rationale for further investigations in combination beyond CTCL, especially in combination with other anti-lymphoma agents in peripheral T-cell lymphomas (PTCL).

“Patients with advanced mycosis fungoides and Sézary syndrome often face a poor prognosis and limited treatment options after multiple prior lines of therapy,” said Prof. Pierluigi Porcu, Director, Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation, Sidney Kimmel Cancer Center, Jefferson Health, Philadelphia and principal investigator of the TELLOMAK trial. “The durability and depth of responses observed with lacutamab in this study are highly promising and represent a significant advancement for this patient population.”

“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. We are encouraged by these results and are actively preparing a Phase III trial in collaboration with health authorities to bring this promising therapy to patients as swiftly as possible,” added Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma.