The two trials evaluating lacutamab, an investigational therapy developed to treat T-cell lymphomas, were put on partial hold by the FDA. The patient died of hemophagocytic lymphohistiocytosis, which is a rare hematologic disorder characterized by significant hyperinflammation and resulting in severe organ damage.
According to Innate Pharma, the partial hold prevents the enrollment of new patients in the phase 2 TELLOMAK trial. Enrollment in a phase 1b study (NCT05321147) has also been delayed. This study has been developed to assess lacutamab for the treatment of refractory or relapsed peripheral T-cell lymphoma.
About Lacutamab
The most common types of advanced cutaneous T-cell lymphoma, a rare cancer, are mycosis fungoides and Sézary syndrome. Lacutamab has been developed as a humanized, anti-KIR3DL2 antibody against both disorders and plays an important role in the regulation of immune responses and disease progression.
TELLOMAK (NCT03902184) is a global multi-cohort and multi-center phase II study designed to include three groups of participants (cohorts) in the United States and Europe. One cohort consists of patients with Sézary syndrome, and two cohorts consist of mycosis fungoides patients.
A Cleveland Clinic spokesperson explained that Sézary syndrome affects the blood, skin, and often the lymph nodes. It is aggressive and spreads rapidly.
The CEO of Innate Pharma, Dr. Mondher Mahjoubi, issued a statement emphasizing that patient safety is of great importance to Innate. He further commented that the company is making every effort to comply with the FDA’s requests, including management and risk mitigation in its ongoing development of lacutamab.
Lacutamab’s Designations include:
- EMA’s PRIME designation
- US FDA’s Fast Track designation for refractory and relapsed Sézary syndrome. Patients must have had a minimum of two previous systemic therapies.
- Orphan Drug Status granted by the EU and FDA for the treatment of cutaneous T-cell lymphoma grants seven years of exclusive marketing rights.
In conclusion, if patients in either study are currently receiving therapy and deriving significant clinical benefit, upon their reauthorizing consent, they may continue treatment.
