UroGen Pharma announced positive Phase 3 ENVISION trial results for UGN-102, a mitomycin-based intravesical solution for recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). The study demonstrated a high complete response rate and durable efficacy in patients, marking a significant step toward a potential new treatment option for this challenging condition. The findings were presented at the Society of Urologic Oncology annual meeting and published in the Journal of Urology.
This news is crucial because LG-IR-NMIBC represents a significant unmet need. Patients with this type of bladder cancer often face frequent recurrences, necessitating repeated surgical procedures. A new, effective, and less invasive treatment option like UGN-102 could substantially improve patient outcomes and quality of life, particularly for elderly patients who may be less able to tolerate repeated surgeries. The positive results from the ENVISION trial could also significantly impact the bladder cancer treatment landscape, offering a much-needed alternative to current standards of care.
The ENVISION trial showed an 82.3% duration of response at 12 months in patients who achieved a complete response after the initial UGN-102 treatment. This durability persisted, with an 80.9% duration of response at both 15 and 18 months. These findings reinforce the initial positive results of a 79.6% complete response rate three months post-treatment. Furthermore, the safety profile of UGN-102 remained consistent with previous trials, characterized by generally mild-to-moderate, resolvable side effects, primarily affecting the urinary tract. The New Drug Application (NDA) for UGN-102 was submitted ahead of schedule and accepted by the FDA, with a target action date set for June 13, 2025.
The positive ENVISION trial results, coupled with the FDA’s acceptance of the NDA, position UGN-102 as a potential game-changer for LG-IR-NMIBC treatment. If approved, UGN-102 could offer a less invasive, more convenient, and potentially more effective treatment option for patients, reducing the need for repeated surgeries and improving long-term outcomes. This development holds promise for a significant advancement in bladder cancer care and could reshape the treatment paradigm for this prevalent condition.
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.
