UroGen Announces New Data from the OPTIMA II Study that Show Median Durability of Response of 24.4 Months for UGN-102, an Investigational Non-Surgical Chemoablative Treatment for Low-Grade, Intermediate-Risk Non-Muscle Invasive Bladder Cancer
-- Results from this ongoing, noninterventional rollover study were presented at the 23rd Annual
“LG-IR-NMIBC is a challenging disease to treat because of the high recurrence rate managed by repetitive surgeries,” says
Patients who completed the OPTIMA II study were eligible to participate in this rollover study. Outcomes include DOR in patients who remained in complete response (CR) at the end of OPTIMA II, events of disease recurrence and progression, post-study treatments and death.
At the time of data cut off (
DOR was calculated as the time from documented CR in OPTIMA II to disease recurrence or death or last adequate disease assessment (for patients who remained in CR). The data cut off for this report is
“UGN-102 uses a similar combination with a simpler delivery method to our currently approved chemoablative medicine and has showed a similar durability of response in LG-IR-NMIBC,” said
About the Phase 2b OPTIMA II Trial
OPTIMA II (OPTimized Instillation of Mitomycin for Bladder Cancer Treatment) is an open-label, single-arm, multi-center Phase 2b clinical trial of investigational agent UGN-102 (mitomycin) for intravesical solution to evaluate its safety and efficacy in patients with LG-IR-NMIBC.
- 65 percent CR at three months
- Kaplan-Meier analysis estimated duration of response to be 72.5 percent at 12 months from initiation of therapy (nine months from CR); median duration of response was not reached
- Treatment with UGN-102 was generally well tolerated, with mostly mild to moderate adverse events reported
Intermediate risk is defined as one or two of the following: multiple tumors, solitary tumor >3 cm, or recurrence (≥ 1 occurrence of LG-NMIBC within one year of the current diagnosis). Patients were to receive six weekly intravesical instillations of 75 mg UGN-102 in an office setting. The chemoablative effect of UGN-102 was assessed three months after initiation of study treatment with CR defined as a negative endoscopic examination, negative cytology, and when indicated, a negative for-cause biopsy. Patients achieving CR were followed quarterly to 12 months after initiation of study treatment to evaluate safety, efficacy, and durability.
Approximately 800,000 people are living with bladder cancer in the
UroGen is biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better. 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. UroGen’s first commercial product 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
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the ongoing non-interventional, rollover study of UGN-102; the ongoing ENVISION Phase 3 trial; the potential of UroGen’s proprietary RTGel technology platform to improve therapeutic profiles of existing drugs; the potential benefits of UGN-102 for the treatment of LG-IR-NMIBC and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: results from initial reports of long term follow-up outcomes may not be indicative of results that may be observed in future clinical practice; the timing and success of clinical trials and potential safety and other complications thereof, including the ENVISION Phase 3 trial; the ability to obtain regulatory approval within the timeframe expected, or at all; the ability to maintain regulatory approval; complications associated with commercialization activities, including complications resulting from the COVID-19 pandemic; the labeling for any approved product; competition in our industry; the scope, progress and expansion of developing and commercializing UroGen’s product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Form 10-Q filed with the
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