ImPact Biotech announced interim Phase 3 trial results for Padeliporfin VTP, a treatment for low-grade upper tract urothelial cancer (UTUC). The interim analysis, which includes data from 50% of the target enrollment, showed a 73% complete response rate in evaluable patients after the initial treatment phase. The treatment continues to demonstrate a safe and tolerable profile.
This positive interim data is crucial for the UTUC treatment landscape. Current standard treatments for UTUC, often involving surgery, can lead to organ damage or loss. Padeliporfin VTP offers a less invasive alternative with the potential for high efficacy, addressing a significant unmet need for a safer and equally effective treatment option. The strong complete response rate suggests it could significantly improve patient outcomes and quality of life.
In the study, 37 of 43 patients who began treatment completed the initial induction phase and were evaluated for efficacy. Of those, 73% achieved a complete response, and an additional 13.5% experienced a partial response. The treatment was generally well-tolerated, with most adverse events being mild to moderate and primarily related to the endoscopic procedure, resolving quickly.
These interim results are highly encouraging and suggest that Padeliporfin VTP may become a game-changer in UTUC treatment. With full enrollment expected in the latter half of 2025 and topline data anticipated by the end of the year, the upcoming results hold significant promise for confirming the treatment’s efficacy and potentially paving the way for regulatory approval and widespread adoption. This could ultimately transform the standard of care for low-grade UTUC.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
