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Mitomycin formulation UGN-102 delivers durable responses in NMIBC


UGN-102 (mitomycin) for intravesical solution induced long-lasting complete responses in patients with low-grade intermediate-risk non-muscle invasive bladder cancer.

UGN-102 (mitomycin) for intravesical solution demonstrated durable clinical activity in patients with low-grade intermediate-risk non-muscle invasive bladder cancer (NMIBC), according to the final results from the phase 2b OPTIMA II trial.1

At 3-months after treatment initiation, the complete response (CR) rate with UGN-102 was 65%. An estimated 72.5% of these patients with CRs maintained their response 12 months after starting therapy. The median duration of response had not been reached.

“We are extremely encouraged by the OPTIMA II data and believe UGN-102 has the potential to provide a safe, durable, outpatient treatment alternative for low-grade intermediate risk non-muscle invasive bladder cancer,” Mark Schoenberg, MD, chief medical officer at UroGen, the manufacturer of UGN-102, stated in a press release.

“We look forward to the expected initiation of our phase 3 trial this year and further exploring the potential of our innovative technology in advancing new treatments for specialty cancers and urologic diseases,” added Schoenberg.

The multicenter, single-arm, open-label phase IIb OPTIMA II trial (NCT03558503) accrued 63 patients with low-grade NMIBC at intermediate risk of recurrence. Overall, 41 of the 63 patients achieved a CR.

The majority of adverse events were considered to be mild to moderate. The most frequently occurring adverse events across all grades included dysuria, urinary frequency, hematuria, urinary urgency, urinary tract infection, and fatigue. There were no serious treatment-related AEs.

“The current approach to treating patients diagnosed with low-grade intermediate risk non-muscle invasive bladder cancer is surgery. In most cases, the cancer comes back and repetitive surgical intervention is required. This puts a tremendous burden on patients and their families and can even be life-threatening,” Andrea Maddox-Smith, chief executive officer, Bladder Cancer Advocacy Network, stated in the press release. “Being able to provide patients with an alternative, non-surgical treatment option that is effective, well-tolerated and durable, would greatly benefit those in the patient community.”

UroGen plans to submit the final data from the OPTIMA II trial for publication in a peer-reviewed journal as well as presentation at an upcoming scientific conference.

Mitomycin gel (UGN-101)

UroGen previously received approval for mitomycin gel (UGN-101; Jelmyto), which the FDA approved in April 2020 as the first therapy to treat low-grade upper tract urothelial cancer (UTUC).2

The approval was based on results from the pivotal phase 3 OLYMPUS trial, in which mitomycin gel elicited a CR rate of 58% in patients with low-grade UTUC. Among the 41 patients who achieved a CR, 19 (46%) continued to respond at 12 months.

According to the FDA, the most frequently occurring adverse events across all grades in patients receiving mitomycin gel were flank pain, urinary tract infection, hematuria, renal dysfunction, fatigue, nausea, abdominal pain, dysuria, and vomiting.


1. Complete and Durable Responses Observed in OPTIMA II Phase 2b Final Results for UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer. UroGen. Published online November 17, 2002. https://bit.ly/36Jc7Kn. Accessed November 17, 2020.

2. FDA Approves First Therapy for Treatment of Low-Grade Upper Tract Urothelial Cancer. Published April 15, 2020. https://bit.ly/2wGE4Es. Accessed April 15, 2020.

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