ImPact Biotech announced updated interim results from its Phase 3 ENLIGHTED study, revealing that Padeliporfin vascular targeted photodynamic (VTP) therapy achieved an 86% complete response (CR) rate in patients with low-grade upper tract urothelial cancer (UTUC). The data, presented at the 16th European Multidisciplinary Congress on Urological Cancers (EMUC 2024), highlights the potential of Padeliporfin VTP as a compelling alternative to invasive surgical interventions.
High Complete Response Rate
The ENLIGHTED study, a single-arm, open-label trial, is evaluating Padeliporfin VTP in up to 100 patients with new or recurrent low-grade, non-invasive UTUC across 29 clinical sites globally. As of the data cut-off on April 29, 2024, 14 patients had completed the Induction Treatment Phase (ITP) and were evaluable for efficacy. Twelve of these 14 patients (86%) achieved a CR at the end of ITP.
Safety and Tolerability
Padeliporfin VTP demonstrated a favorable safety profile, consistent with previous data from the Phase 1 study and preliminary Phase 3 results. 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.
Clinical Significance
Gautier Marcq, M.D., an investigator in the ENLIGHTED study, noted that current standards of care for UTUC often require invasive surgery, leading to organ injury or loss. He emphasized that Padeliporfin VTP could offer an alternative that doesn't force patients to compromise between organ preservation and effective cancer treatment.
Study Design and Objectives
The ENLIGHTED study consists of an Induction Treatment Phase (ITP) and a Maintenance Treatment Phase (MTP). During ITP, patients receive one-to-three treatments with VTP therapy at four-week intervals until a complete response is achieved. MTP involves standard-of-care treatment alongside VTP therapy administered every three months for up to 12 months. The primary objective is to assess the response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability, and duration of response.
Future Plans
ImPact Biotech anticipates completing enrollment in the ENLIGHTED study by early 2025 and plans to use the data to support registration of Padeliporfin VTP for low-grade UTUC. The company also intends to initiate a Phase 1 study to explore the potential of Padeliporfin VTP in other unresectable solid tumors, starting with pancreatic ductal adenocarcinoma (PDAC).
