ImPact Biotech announced updated interim results from its Phase 3 ENLIGHTED 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 16th European Multidisciplinary Congress on Urological Cancers (EMUC 2024), highlight 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 patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. As of the data cut-off on April 29, 2024, 12 out of 14 (86%) response-evaluable patients achieved a complete response (CR) at the end of the Induction Treatment Phase (ITP).
Safety and Tolerability
Padeliporfin VTP was well-tolerated, with a safety profile consistent with previous data from Phase 1 and preliminary Phase 3 results. Adverse events (AEs) were primarily Grade 1 or 2, mostly 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.
ENLIGHTED Study Design
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 follows with 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.
Potential to Transform UTUC Treatment
Gautier Marcq, M.D., an investigator in the ENLIGHTED study, noted the potential of Padeliporfin VTP to reshape the therapeutic landscape in UTUC. "Current standards of care in this indication often require an invasive surgical intervention, resulting in many cases in organ injury or loss, or a burdensome therapeutic regimen that fails to match surgery in efficacy," said Marcq. "These results highlight Padeliporfin VTP as a compelling alternative, which may not require patients to compromise between sparing their organs and treating their cancer."
Future Plans
ImPact Biotech expects to complete enrollment in the ENLIGHTED study by early 2025. The company also plans to replicate the effect of Padeliporfin VTP in other unresectable solid tumors, beginning with a planned Phase 1 study in pancreatic ductal adenocarcinoma (PDAC).
