What's Happening?
Innate Pharma has announced that the U.S. Food and Drug Administration (FDA) has completed its review of the confirmatory Phase 3 protocol for lacutamab, a treatment for cutaneous T-cell lymphomas (CTCL), with no further comments, allowing the trial to proceed.
The planned Phase 3 trial, named TELLOMAK-3, is designed to demonstrate the efficacy of lacutamab in patients with Sézary syndrome and Mycosis fungoides who have failed at least one prior line of systemic therapy. The trial will include two independent cohorts, with one enrolling patients with Sézary syndrome post-mogamulizumab treatment and the other enrolling patients with Mycosis fungoides. The primary endpoint for both cohorts is progression-free survival evaluated by blinded central review. Data from the Phase 2 TELLOMAK trial showed durable activity, a favorable safety profile, and improvements in patients' quality of life.
Why It's Important?
The FDA's clearance for the Phase 3 trial of lacutamab is a significant step forward for Innate Pharma, potentially leading to accelerated approval for treating Sézary syndrome. This development is crucial for patients with CTCL, as it offers a promising new treatment option for those who have not responded to existing therapies. The trial's success could enhance Innate Pharma's position in the biotechnology sector, particularly in the field of immunotherapy for cancer. Additionally, the progress of lacutamab and other assets in Innate Pharma's pipeline, such as IPH4502 and monalizumab, underscores the company's strategic focus on high-value clinical assets, which could deliver meaningful value for patients and shareholders.
What's Next?
Innate Pharma is set to initiate the confirmatory Phase 3 TELLOMAK-3 trial in the first half of 2026. The company is also progressing with other clinical trials, including the Phase 1 trial for IPH4502 and the Phase 3 PACIFIC-9 trial for monalizumab, with data readouts expected in 2026. As Innate Pharma advances its pipeline, it plans to streamline its organization through planned layoffs, subject to endorsement by French authorities. The company aims to continue leveraging its innovative targets and collaborations with leading biopharmaceutical companies to advance its portfolio of differentiated antibody therapeutics.
