ImPact Biotech announced updated interim results from its ENLIGHTED Phase 3 study, revealing a high complete response rate with Padeliporfin vascular targeted photodynamic (VTP) therapy in patients with low-grade upper tract urothelial cancer (UTUC). The data, presented at the Society of Urologic Oncology (SUO) 2024 meeting, highlight the potential of Padeliporfin VTP as an effective and safe treatment option for this patient population.
The ENLIGHTED trial is a single-arm, open-label study evaluating Padeliporfin VTP in patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. The trial includes an Induction Treatment Phase (ITP) and a Maintenance Treatment Phase (MTP). During ITP, patients receive one-to-three VTP treatments at four-week intervals until a complete response (CR) is achieved. MTP involves standard-of-care treatment alongside VTP therapy every three months for up to 12 months.
Promising Efficacy and Safety
As of the data cut-off on July 22, 2024, 32 patients had begun treatment, with 20 completing the ITP and being evaluable for efficacy. Key findings include:
- A complete response (CR) was observed in 85% (17/20) of response-evaluable patients at the end of the ITP.
- Padeliporfin VTP was well-tolerated, with a safety profile consistent with previous Phase 1 and preliminary Phase 3 data.
- Adverse events (AEs) were primarily Grade 1 or 2, mainly pain-related, and resolved within two to seven days. Only one patient experienced a Grade 3 serious adverse event related to the VTP therapy, which resolved within two days.
- No Grade 4 or 5 serious adverse events were observed.
Expert Commentary
Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech, stated, "As data from the ENLIGHTED trial matures, we continue to be encouraged by compelling and sustained efficacy signals from treatment with Padeliporfin VTP. These results further underscore the potential for Padeliporfin VTP to transform the treatment paradigm in low-grade UTUC, offering efficacy in line with standard of care but without the associated risk of organ injury or loss."
Gautier Marcq, M.D., an investigator in the ENLIGHTED study, noted the potential of Padeliporfin VTP to reshape the therapeutic landscape in UTUC, offering an alternative to invasive surgical interventions that often result in organ injury or loss. He expressed optimism about the data and looked forward to improved treatment outcomes for patients with UTUC.
Future Directions
ImPact Biotech is continuing to enroll patients in the ENLIGHTED study and anticipates completing enrollment by early 2025. The company also plans to investigate Padeliporfin VTP in other unresectable solid tumors, starting with a Phase 1 study in pancreatic ductal adenocarcinoma (PDAC).
