FDA Clears Innate Pharma to Begin Phase 3 Trial of Lacutamab in CTCL
Innate Pharma SA has received FDA clearance to begin the TELLOMAK 3 Phase 3 trial of lacutamab for cutaneous T-cell lymphomas (CTCL). The FDA's review of the trial protocol was completed without comments, allowing the trial to proceed. This follows positive Phase 2 results showing durable activity and a favorable safety profile. The Phase 3 trial is set to start in the first half of 2026, with potential for accelerated approval for Sézary syndrome during the trial.
Innate Pharma SA has announced that the U.S. Food and Drug Administration (FDA) has cleared the company to proceed with the TELLOMAK 3 confirmatory Phase 3 trial of lacutamab in cutaneous T-cell lymphomas (CTCL). The FDA completed its review of the Phase 3 protocol with no further comments, allowing the trial to move forward. This regulatory milestone follows robust Phase 2 data from the TELLOMAK trial, which demonstrated durable activity, a favorable safety profile, and improvements in quality of life for patients. The company is now preparing to initiate the Phase 3 TELLOMAK 3 trial in the first half of 2026, with the regulatory pathway potentially including accelerated approval for Sézary syndrome once the trial is underway. No grant or funding involving multiple organizations was mentioned in the announcement. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Innate Pharma SA published the original content used to generate this news brief via Business Wire (Ref. ID: 20251109757297) on November 10, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
