Administration of Padeliporfin: Best Practices

Padeliporfin vascular targeted photodynamic therapy (VTP) is a groundbreaking treatment for low-grade upper tract urothelial carcinoma (UTUC), offering a minimally invasive and effective solution for patients. This therapy combines the drug padeliporfin, a photosensitizer, with a laser light delivery system to target and ablate tumors in the upper urinary tract. In this article, we will delve into the best practices for padeliporfin administration, highlighting its efficacy, safety, and the latest clinical trial updates.

For those interested in learning more about padeliporfin and its applications, visit ImPact Biotech’s website for comprehensive information on this innovative therapy.

Understanding Padeliporfin VTP

Padeliporfin VTP is a combination product that includes the intravenous administration of padeliporfin and the use of a laser light delivery system. This system emits near-infrared light at 753 nm, which is delivered to the target lesion(s) in the upper tract urothelium via an optic fiber.

Clinical Trial Updates

The Phase 3 ENLIGHTED trial is a single-arm, non-randomized, open-label study evaluating the efficacy and safety of padeliporfin VTP in patients with low-grade UTUC. The trial has reached 50% patient enrollment and is expected to complete enrollment by the first quarter of 2025.

Efficacy and Safety

Interim results from the ENLIGHTED trial have shown promising efficacy and safety profiles. Of the 13 patients who completed the induction phase, 10 (77%) achieved a complete response, and 3 (23%) achieved a partial response. The most common adverse events were grade 1-2, including flank pain, vomiting, fatigue, nausea, and hematuria, all of which resolved within 2 to 7 days.

Best Practices for Administration

1. Patient Selection: Patients with new or recurrent low-grade, non-invasive upper tract urothelial carcinoma are eligible for padeliporfin VTP treatment.
2. Induction Treatment Phase: Patients receive 1-3 padeliporfin VTP treatments under anesthesia, spaced about four weeks apart.
3. Maintenance Treatment Phase: Patients who achieve a complete response in the induction phase can enter the maintenance phase, where VTP treatments can be provided every 3 months for patients with recurrent tumors.
4. Long-term Follow-up: Patients are followed for safety for 48 months with no VTP treatments after completing the maintenance phase.

Conclusion

Padeliporfin VTP is a promising treatment for low-grade upper tract urothelial carcinoma, offering a minimally invasive and effective solution for patients. By understanding the best practices for padeliporfin administration, healthcare professionals can provide optimal care for their patients.