ImPact Biotech will present updated preliminary results from its Phase 3 ENLIGHTED study of Padeliporfin VTP in patients with low-grade upper tract urothelial cancer (LG UTUC) at the 2025 American Urological Association Annual Meeting. The company will also share long-term follow-up data from the Phase 2b PCM-204 trial evaluating Padeliporfin VTP in men with intermediate-risk prostate cancer. The presentations will take place on April 27, 2025.
These updates are crucial for the urological oncology field, as LG UTUC represents a significant unmet need. Current treatment options often involve invasive surgery with potential for substantial morbidity. Positive data from the ENLIGHTED trial could establish Padeliporfin VTP as a less invasive, potentially kidney-sparing alternative, improving patient outcomes and quality of life. Additionally, the prostate cancer data will further illuminate the potential of this therapy in a different cancer type, broadening its potential clinical impact.
The ENLIGHTED trial is a global, single-arm, open-label study enrolling up to 100 patients. It involves an Induction Treatment Phase (ITP) with one to three treatments at four-week intervals, followed by a Maintenance Treatment Phase (MTP) with standard-of-care follow-ups and potential additional treatments for up to 12 months. Padeliporfin is administered intravenously and activated locally in the tumor via laser light delivered through a ureteroscope. The primary endpoint is the response rate at the end of the ITP. The PCM-204 trial provides 48-month follow-up data on Padeliporfin VTP’s use in intermediate-risk prostate cancer, offering insights into long-term efficacy and safety.
Positive results from the ENLIGHTED study could lead to regulatory approval and commercialization of Padeliporfin VTP for LG UTUC, significantly impacting the treatment landscape for this cancer. Furthermore, encouraging long-term data in prostate cancer could expand the application of this technology to other solid tumors, potentially positioning Padeliporfin VTP as a versatile and valuable tool in the fight against cancer. Continued research and development in other indications, such as high-grade UTUC, pancreatic ductal adenocarcinoma, and non-small cell lung cancer, will further define the role of this promising therapy in oncology.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
