Priority Medicines (PRIME) designation supports the potential for lacutamab to benefit Sézary Syndrome patients in need of new treatment options
The PRIME designation is based on efficacy data in relapsed or refractory SS patients from the completed Phase 1 dose escalation and expansion trial, and is supported by safety data in SS patients from both the Phase 1 trial and ongoing Phase 2 TELLOMAK clinical trial. This is the first time PRIME designation has been granted for a potential treatment of any sub-type of T-cell lymphoma.
"We are pleased that the EMA has granted PRIME designation for lacutamab, as Sézary syndrome is the most aggressive form of cutaneous T-cell lymphoma and patients facing advanced disease are in great need of new, targeted treatment options,” said
PRIME designation by the EMA supports the development of promising new medicines that target an unmet medical need. It allows for proactive support from the EMA throughout the clinical development process and enables accelerated assessment. Lacutumab was also awarded Fast Track designation by the
About Sézary Syndrome:
Sézary syndrome is the leukemic variant of cutaneous T-cell lymphoma (CTCL), a heterogeneous group of non-Hodgkin’s lymphomas which arise primarily in the skin. Patients often experience very poor quality of life with severe and debilitating pruritus (chronic itchy skin). Despite recent advancements, SS is associated with a high relapse rate with currently available therapies.
About Lacutamab:
Currently in Phase 2 development, lacutamab (IPH4102) is a proprietary first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, designed for treatment of CTCL, an orphan disease. This group of rare cutaneous lymphomas of T lymphocytes has a poor prognosis with few therapeutic options at advanced stages.
KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up to 85% of them with certain aggressive CTCL subtypes, in particular, SS. It has a restricted expression on normal tissues. Lacutamab was granted orphan drug designation in the
About the TELLOMAK Trial:
TELLOMAK is a global, open-label, multi-cohort Phase 2 clinical trial conducted in
- As a single agent in approximately 60 patients with Sézary syndrome who have received at least two prior systemic therapies, including mogamulizumab
- As a single agent in approximately 90 patients with mycosis fungoides (MF) who have received at least two systemic therapies
In patients with MF, the study is designed to evaluate the benefit of lacutamab according to KIR3DL2 expression. The study comprises two cohorts in MF, testing lacutamab in KIR3DL2 expressing and non-expressing patients. These cohorts follow a Simon 2-stage design that will terminate if treatment is considered futile. The Sézary syndrome cohort of the study could enable the registration of lacutamab in this indication.
The primary endpoint of the trial is objective response rate. Key secondary measures include incidence of treatment emergent adverse events, quality of life, overall response rate, progression-free survival and overall survival.
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- Lacutamab PRIME PR FINAL
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