Tumor-free complete response rate at three months was 65% for patients who only received UGN-102, compared to a 64% complete response rate at three months for patients who underwent TURBT. TURBT is the current standard of care for patients with this type of cancer.
“The publication of our ATLAS data in The Journal of Urology adds another chapter to our understanding of the potential of UGN-102 as a treatment for patients with LG-IR-NMIBC, who often face multiple surgeries due to the recurring nature of this cancer,” said Mark Schoenberg, M.D., Chief Medical Officer at UroGen. “Our hope is that one day urologists may have an effective, non-surgical therapy option beyond TURBT that can be used to address this large patient population.”
The Phase 3 ATLAS clinical trial, which met its primary endpoint, evaluated the efficacy, durability, and safety of UGN-102 with or without TURBT vs. TURBT alone in 282 patients with LG-IR-NMIBC. UroGen recently announced positive topline data from ATLAS and the Phase 3 ENVISION trial. The ENVISION trial evaluated the efficacy and safety of UGN-102 as a primary chemoablative therapy in 240 patients with LG-IR-NMIBC and met its primary endpoint by demonstrating that patients treated with UGN-102 had a 79.2% rate of complete response at 3-months following the initial treatment.
The Journal of Urology publication includes the following findings from ATLAS:
Tumor-free complete response 3 months after initial treatment was achieved by 92 patients (65%) who received UGN-102 and 89 patients (64%) treated by TURBT.
UGN-102 was generally well tolerated, with a side effect profile similar to that of previous clinical trials.
The estimated probability of remaining event free 15 months after randomization was 72% for UGN-102 ± TURBT and 50% for TURBT monotherapy [hazard ratio 0.45].
“While TURBT is the standard treatment for bladder cancer, the recurrent nature of LG-IR-NMIBC means that patients will undergo multiple surgeries that come with risks for this older patient population,” says Sandip Prasad, M.D., M.Phil., Director of Genitourinary Surgical Oncology, Morristown Medical Center/Atlantic Health System, NJ, and Chief Investigator in the ATLAS trial. “It is exciting to consider what a potential non-surgical therapeutic alternative could mean for both patients and doctors who are eager for additional options.”Additional data evaluating the secondary endpoint of the ENVISION trial, Duration of Response, is expected in 2024. Assuming positive findings, a New Drug Application (NDA) is anticipated to be submitted to the U.S. Food and Drug Administration (FDA) in the same year.
About UGN-102
UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel® technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive findings from the durability of response endpoint from the ENVISION Phase 3 study, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024. If approved, UGN-102 would be the first non-surgical primary therapeutic to treat a subset of bladder cancer characterized by high recurrence rates and multiple surgeries.
About ATLAS
ATLAS is a global, open-label, randomized controlled Phase 3 trial designed to assess the efficacy and safety of UGN-102, with or without TURBT, vs. TURBT alone in patients diagnosed with LG-IR-NMIBC. The trial enrolled 282 patients in clinical sites in the U.S., Europe and Israel. Patients were randomized 1:1 to either UGN-102 or TURBT. Patients in the UGN-102 arm were treated with six weekly intravesical instillations of UGN-102. At the 3-month time point, patients were assessed for response. Patients who demonstrated a complete response to either UGN-102 or TURBT, were assessed for long-term follow-up for evidence of recurrence. Patients who demonstrated presence of persistent disease at 3-months, in either arm, underwent a TURBT and continued for long-term follow-up for evidence of recurrence. The primary endpoint of the study is disease-free survival. Learn more about the ATLAS trial at www.clinicaltrials.gov (NCT04688931).
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. JELMYTO® (mitomycin) for pyelocalyceal solution and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.urogen.com to learn more or follow us on Twitter, @UroGenPharma.
Source: The Journal of Urology Publishes Peer-Reviewed Article Highlighting UGN-102 Data in Non-Surgical Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer. Urogen Pharma Inc. 2023 [Press Release]
Related Content: Treatment of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer with UGN-102 ± Transurethral Resection of Bladder Tumor (TURBT) Compared to TURBT Monotherapy: A Randomized, Controlled, Phase 3 Trial (ATLAS).