ImPact Biotech completes ENLIGHTED Phase 3 for padeliporfin VTP
ImPact Biotech has completed treatment for all 91 patients enrolled in the Phase 3 ENLIGHTED trial of its padeliporfin vascular targeted photodynamic therapy (VTP) in low-grade upper tract urothelial carcinoma (LG-UTUC). The Tel Aviv-based company said preliminary data show encouraging complete response rates, durable responses and a consistent safety profile, with topline results and a formal NDA submission targeted for 2027.
The milestone follows a pre-NDA meeting with the US Food and Drug Administration in April 2026, at which the agency acknowledged the potential clinical meaningfulness of padeliporfin VTP in LG-UTUC. The FDA has confirmed a registrational pathway and streamlined package requirements, allowing ImPact to draw on supplemental non-clinical modules from a prior NDA submission for padeliporfin VTP in advanced localised prostate cancer, reducing the regulatory burden for the new submission.
Trial design and interim data
ENLIGHTED is a single-arm, open-label pivotal study conducted across 29 sites globally. The trial enrolled patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. Treatment is delivered in two phases: an induction phase of one to three VTP sessions at four-week intervals until a complete response is achieved, followed by a maintenance phase combining standard-of-care with VTP every three months for up to 12 months. The primary objective is response rate at the end of the induction phase, with secondary endpoints covering safety, tolerability and duration of response.
Interim data will be presented as an ePoster at the ESMO Congress in Madrid on 23-27 October 2026, with Dr Asaf Shvero of Sheba Medical Center as presenting author.
Eyal Morag, Chief Medical Officer, said the completion of treatment "represents a major milestone towards our goal of delivering a next-generation treatment option for patients with low-grade UTUC," adding that the results support padeliporfin VTP's potential as a "minimally invasive, organ-sparing" approach.
Market context and regulatory read-across
LG-UTUC is a rare but clinically significant malignancy. Because upper-tract tumours are often managed by surgical removal of the kidney and ureter, organ-sparing alternatives carry considerable appeal, particularly for patients with bilateral disease or compromised renal function. There is currently no FDA-approved drug specifically indicated for LG-UTUC, giving ImPact a potential first-mover position if the NDA is accepted and reviewed on standard timelines.
ImPact is also in discussions with the FDA on an expanded access programme that would allow eligible US patients to receive padeliporfin VTP ahead of any approval decision. The company is evaluating "strategic commercialisation opportunities," though no partner has been named publicly. Beyond ENLIGHTED, padeliporfin VTP is in a Phase 1 dose-escalation study in unresectable locally advanced pancreatic ductal adenocarcinoma, a notoriously difficult indication, with earlier-stage work planned in high-grade UTUC and NSCLC. The breadth of the pipeline may attract partnership interest, though each indication will require its own clinical package. The ESMO interim readout in October will be the first significant public dataset for the programme and is likely to draw close attention from urological oncologists and potential licensing partners alike.