Pentixapharm Holding AG has announced the treatment of the first patient in a Phase I/II clinical trial evaluating Lu177-PentixaTher for relapsed/refractory CXCR4 positive acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The PENTILULA trial (NCT06356922), funded by the French Ministry of Health and led by investigators from the University Hospital in Nantes, marks a significant advancement in targeted radiotherapy for hematologic malignancies.
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 maximal tolerated dose (MTD) of Lu177-PentixaTher. Secondary objectives include examining 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 radiotherapeutic that targets the chemokine-4 receptor (CXCR4). This approach builds upon promising clinical results previously observed in T-cell lymphoma, as highlighted in a January 2023 publication in the Journal of Nuclear Medicine. The combination of PentixaTher with Lutetium-177, a radioisotope used in castration-resistant prostate cancer and neuroendocrine tumors, represents a novel strategy for treating AML and ALL.
Clinical Need and Current Treatment Landscape
AML and ALL are aggressive blood cancers with significant unmet medical needs. AML, the most common 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, including intensive chemotherapy and stem cell transplantation, can have severe side effects. Effective radiotherapies in other indications are currently reimbursed with more than 100,000 USD per patient.
Expert Commentary
"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," said Dr. Dirk Pleimes, Group CEO and CMO at Pentixapharm. Professor Françoise Kraeber-Bodéré of the Nuclear Medicine Department and Professor Patrice Chevallier of the Hematology Department in Nantes are leading the study.
