In a groundbreaking development for bladder cancer treatment, researchers will present the first-in-human data for a novel radioligand therapy at the American Society of Clinical Oncology's Genitourinary Cancers Symposium (ASCO-GU 2025) in San Francisco. The case study showcases a complete response in a late-stage muscle-invasive bladder cancer (MIBC) patient treated with Pentixapharm's Lu177-PentixaTher compound.
Treatment Approach and Clinical Response
The innovative treatment protocol combined three cycles of neoadjuvant combination chemotherapy with intravesical administration of the CXCR4-targeting radiopharmaceutical. Prior to treatment, Ga68-PentixaFor PET/CT imaging confirmed intravesical CXCR4 expression, providing a rational basis for the targeted therapy approach.
Following Lu177-PentixaTher instillation, pathological examination post-transurethral resection revealed a complete response, suggesting significant potential for bladder preservation in MIBC patients. The intravesical administration route represents a particular advantage, enabling localized treatment delivery with enhanced precision while minimizing systemic exposure and potential adverse effects.
Expanding Clinical Evidence
The successful case study adds to mounting evidence supporting CXCR4 as a viable therapeutic target across multiple oncology indications. To date, Pentixapharm has accumulated clinical experience with PentixaTher in over 100 patients, laying a strong foundation for their sponsored clinical development program.
Ongoing Clinical Development
Building on these promising results, Pentixapharm has expanded its clinical program. In November 2024, the company initiated a Phase I/II trial in Nantes, France, investigating PentixaTher in patients with acute myeloid and lymphoblastic leukemia (AML/ALL).
Dr. Ralph Wirtz will present the detailed findings at ASCO-GU 2025's Poster Session B on February 14, providing the medical community with comprehensive data on this novel therapeutic approach.
