Pentixapharm Holding AG announced the treatment of the first patient in a Phase I/II clinical trial of Lu177-PentixaTher for adults with relapsed/refractory CXCR4 positive acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The PENTILULA trial (NCT06356922) is a multicenter, open-label study funded by the French Ministry of Health and led by investigators at the University Hospital in Nantes. This trial marks a significant step in expanding targeted radiotherapy options for hematologic malignancies.
Trial Design and Objectives
The PENTILULA trial plans 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). The treatment combines PentixaTher with Lutetium-177, a radioisotope already used in treating castration-resistant prostate cancer and neuroendocrine tumors. This approach builds on promising clinical results highlighted in a 2023 Journal of Nuclear Medicine publication, which demonstrated potential in treating T-cell lymphoma.
Clinical Need and Significance
AML is the most common type of acute leukemia in adults, with approximately 20,000 new cases per year in the United States and a low five-year survival rate of 31.9%. ALL is the most common cancer in children, also affecting adults. Current treatments often involve intensive chemotherapy and stem cell transplantation, which can have severe side effects. According to Pentixapharm, effective radiotherapies in other indications are currently reimbursed with more than 100,000 USD per patient, highlighting the potential economic value of effective radiopharmaceutical treatments.
Expert Commentary
Dr. Dirk Pleimes, Group CEO and CMO at Pentixapharm, stated, "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."
Professor Françoise Kraeber-Bodéré of the Nuclear Medicine Department and Professor Patrice Chevallier of the Hematology Department in Nantes are leading the study. Pentixapharm is committed to supporting this research by leveraging their therapeutic knowledge and facilitating access to the compound.
