Innate Pharma’s Lacutamab Earns FDA Breakthrough Therapy Designation: A New Hope for T-Cell Lymphoma Patients

 

Innate Pharma’s Lacutamab Earns FDA Breakthrough Therapy Designation: A New Hope for T-Cell Lymphoma Patients**  

The U.S. Food and Drug Administration (FDA) has granted **Breakthrough Therapy Designation (BTD)** to Innate Pharma’s investigational drug **lacutamab**, marking a pivotal milestone in the treatment of patients with advanced **T-cell lymphomas**. This designation underscores lacutamab’s potential to address a critical unmet need for patients battling rare and aggressive forms of blood cancer. Here’s what you need to know about this breakthrough and its implications.  

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### **What is Breakthrough Therapy Designation?**  

The FDA’s BTD is reserved for drugs that demonstrate **substantial improvement over existing therapies** in treating serious or life-threatening conditions, based on preliminary clinical evidence. It accelerates development and review, offering sponsors intensive FDA guidance, rolling data submission, and potential priority review. For lacutamab, this recognition highlights its promise in transforming outcomes for patients with **KIR3DL2-expressing relapsed/refractory peripheral T-cell lymphoma (PTCL)** and **Sézary syndrome**, a rare subtype of cutaneous T-cell lymphoma (CTCL).  

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### **Lacutamab: Targeting a Novel Pathway**  

**Lacutamab** is a first-in-class monoclonal antibody designed to target **KIR3DL2**, a protein expressed on the surface of malignant T-cells in certain lymphomas. By binding to KIR3DL2, lacutamab triggers antibody-dependent cellular cytotoxicity (ADCC), directing the immune system to destroy cancer cells while sparing healthy tissues.  

This precision approach is particularly relevant for PTCL and Sézary syndrome, where current treatments—chemotherapy, radiation, or immunosuppressants—often provide limited benefit and carry significant side effects.  

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### **The Data Behind the Designation**  

The FDA’s decision was supported by encouraging results from the **Phase 2 TELLOMAK trial** (NCT03902184), which evaluated lacutamab in patients with **KIR3DL2-positive CTCL and PTCL**. Key findings include:  

- **Durable Responses**: In Sézary syndrome patients, lacutamab demonstrated a **44% objective response rate (ORR)**, with some patients achieving complete remission.  

- **Favorable Safety Profile**: Treatment-related adverse events were manageable, with infusion-related reactions