Phase 3 trials of nonsurgical therapy for low-grade bladder cancer meet primary endpoints
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Two phase 3 trials that evaluated a nonsurgical therapy for certain patients with bladder cancer met their primary endpoints, according to the agent’s manufacturer.
UGN-102 (UroGen Pharma Ltd.) for intravesical solution is an investigational drug formulation of mitomycin. The sustained release, hydrogel-based formulation — delivered in an outpatient setting using a standard urinary catheter — is designed to allow for longer exposure of mitomycin to bladder tissue, according to a UroGen Pharma press release.
The randomized phase 3 ATLAS trial evaluated the efficacy and safety of UGN-102 with or without transurethral resection of bladder tumor (TURBT) vs. TURBT alone for patients with low-grade, intermediate-risk, non-muscle-invasive bladder cancer. Researchers assigned 282 patients 1:1 to UGN-102 or TURBT.
Patients assigned UGN-102 received six weekly intravesical instillations of UGN-102.
At 3 months, investigators evaluated patients for response. Those who achieved complete response to UGN-102 or TURBT remained in long-term follow-up. Those who exhibited presence of persistent disease underwent TURBT.
The study met its primary endpoint of DFS, showing a 55% reduction in risk for recurrent, progression or death in the UGN-102 group. At 3 months, researchers reported complete response rates of 64.8% among those who only received UGN-102 and 63.6% among those who only underwent TURBT.
The randomized phase 3 ENVISION trial assessed UGN-102 as primary chemoablative therapy for patients with low-grade, intermediate-risk non-muscle-invasive bladder cancer.
The 240 patients received six once-weekly intravesical instillations of UGN-102. Complete response rate at 3 months served as the primary endpoint.
More than three-quarters (79.2%) of study participants achieved complete response 3 months after initial treatment. Data about the secondary endpoint of response duration are expected next year.
If additional findings are positive, a new drug application will be submitted to the FDA in 2024, according to the release.
UGN-102 exhibited an adverse event profile consistent with that observed in prior trials, according to the release.
“[Although] TURBT is the standard treatment for bladder cancer, the recurrent nature of [low-grade, intermediate-risk, non-muscle-invasive bladder cancer] means that patients will undergo multiple surgeries that come with risks for this older patient population,” Sandip Prasad, MD, MPhil, director of genitourinary surgical oncology at Morristown Medical Center/Atlantic Health System in New Jersey, said in the release. “Based on these compelling data, I am optimistic that UGN-102, if approved, may change the treatment paradigm for these patients who lack nonsurgical options to manage the ongoing burden of this highly recurrent disease.”
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