Innate's lacutamab receives FDA breakthrough designation

Innate Pharma has achieved a significant milestone with the US Food and Drug Administration (FDA) granting breakthrough therapy designation to lacutamab for adults suffering from relapsed or refractory Sézary syndrome. Lacutamab represents a pioneering class of antibodies specifically formulated to target the killer cell immunoglobulin-like receptor 3DL2 (KIR3DL2), aiming to trigger cytotoxic effects. This innovative treatment is currently undergoing trials for cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma.

The FDA's designation follows promising outcomes from initial clinical evaluations. The Phase I study, along with the Phase II TELLOMAK trial, demonstrated lacutamab’s potential in terms of efficacy and safety for patients who have previously undergone a minimum of two systemic treatments, such as mogamulizumab. TELLOMAK is an extensive Phase II clinical study that is being conducted across the United States and Europe. It targets patients with Sézary syndrome and mycosis fungoides, employing an open-label, multi-cohort framework. The primary aim of the trial is to assess the objective global response rate, while secondary measures include progression-free survival, overall survival, response duration, and quality of life.

Innate Pharma has been actively engaged in the regulatory process, having previously secured fast track designation from the FDA in 2019, and obtaining the PRIME designation from the European Medicines Agency in 2020 for lacutamab. At present, the company is collaborating with regulatory bodies to initiate a confirmatory Phase III trial for CTCL and is seeking partnerships to advance this effort. Furthermore, lacutamab has been granted orphan drug status in both the European Union (EU) and the United States for treating CTCL.

Sonia Quaratino, Innate Pharma's chief medical officer, has emphasized the significant medical need for targeted therapies in addressing Sézary syndrome. This condition is an aggressive and rare variant of cutaneous T-cell lymphoma, where patients with advanced disease stages often endure a poor quality of life and have a critical need for innovative treatment solutions.

In recent developments, however, Innate Pharma made the decision in March 2024 to halt plans for evaluating lacutamab as a standalone treatment for KIR3DL2-expressing refractory/relapsing peripheral T-cell lymphoma. This decision followed unsatisfactory data from a Phase Ib trial, highlighting the challenges and complexities in developing effective therapies for these conditions.

Overall, lacutamab's journey through clinical trials and regulatory approvals underscores Innate Pharma's commitment to addressing the unmet needs in the treatment landscape for cutaneous T-cell lymphomas. The ongoing efforts and collaborations reflect the broader goal of delivering new, targeted treatment options that can significantly improve patient outcomes and quality of life, especially for those with aggressive and rare forms of lymphoma like Sézary syndrome.