Pentixapharm Holding AG has announced the treatment of the first patient in a Phase I/II clinical trial of Lu177-PentixaTher for relapsed/refractory CXCR4-positive acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The trial, named PENTILULA (NCT06356922), is funded by the French Ministry of Health and is being conducted at the University Hospital in Nantes, France.
Trial Design and Objectives
The PENTILULA trial is a multicenter, open-label study designed to enroll up to 21 patients with relapsed/refractory AML or ALL over 24 months, with a total study duration of 36 months. The primary objective is to determine the maximum tolerated dose (MTD) of Lu177-PentixaTher. Secondary objectives include evaluating key efficacy parameters such as overall response rate (ORR) and complete remission (CR) following infusion of the radiotherapeutic agent.
Lu177-PentixaTher: A Novel Radiopharmaceutical Approach
Lu177-PentixaTher is a novel radiopharmaceutical therapy that combines PentixaTher, a CXCR4-targeting ligand, with Lutetium-177, a radioisotope widely used in the treatment of castration-resistant prostate cancer and neuroendocrine tumors. This approach aims to deliver targeted radiotherapy to cancer cells expressing the CXCR4 receptor.
Clinical Significance and Unmet Need
AML and ALL are aggressive blood cancers with significant unmet medical needs. AML, the most common type of acute leukemia in adults, has a low five-year survival rate of 31.9% in the United States. ALL is the most common cancer in children but also affects adults. Current treatments often involve intensive chemotherapy and stem cell transplantation, which can have severe side effects. According to Dr. Dirk Pleimes, Group CEO and CMO at Pentixapharm, "Although treatments for acute leukemia have advanced, many patients continue to have limited options and face poor outcomes. We believe PentixaTher holds significant potential to address these unmet needs, offering a valuable radiopharmaceutical theranostic approach tailored to the individual patients with hematologic malignancies."
Prior Evidence and Future Directions
Previous research, including a peer-reviewed publication in the Journal of Nuclear Medicine in January 2023, has highlighted promising clinical results with PentixaTher in T-cell lymphoma. The PENTILULA trial expands the evidence base for PentixaTher in hematologic malignancies, particularly in AML and ALL, where the incidence and medical need are higher than in T-cell lymphoma.
Expert Perspectives
Professor Françoise Kraeber-Bodéré, Head of the Department of Nuclear Medicine at the University Hospital in Nantes, and Professor Patrice Chevallier, a specialist in Hematology, are leading the investigator team. They will evaluate this novel radiotherapeutic treatment option, with full support from Pentixapharm.
