On December 2, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported new data from the OPTIMA II study designed to obtain long-term follow-up data on UGN-102 that shows median duration of response (DOR) of 24.4 months for UroGen’s investigational drug UGN-102 currently in Phase 3 development for low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) (Press release, UroGen Pharma, DEC 2, 2022, View Source [SID1234624748]). The study (Abstract #193) was presented at SUO on December 2.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"LG-IR-NMIBC is a challenging disease to treat because of the high recurrence rate managed by repetitive surgeries," says William C. Huang, M.D., FACS, Professor and Vice Chair of Urology at NYU Langone Health and Principal Investigator of the OPTIMA II trial. "The OPTIMA II Phase 2b trial showed significant tumor response benefit for patients using the novel chemoablative therapy UGN-102 for LG-IR-NMIBC and this latest analysis shows that the treatment benefit lasted for more than two years. I look forward to additional data on UGN-102, including evidence from the ENVISION Phase 3 study."
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 (February 25, 2022), data were available for 15 of the 25 patients. The median DOR among the 15 patients was 24.4 months (10.1 to 30.7 months). Seven patients remained in CR, six patients had recurrence of LG disease, one patient had progression to high-grade disease and one patient withdrew consent (no longer mobile) but remained in CR at the last evaluation prior to discontinuation. All patients were alive at the last contact, and five patients were known to have had post-study treatment with transurethral resection of the bladder tumors (three patients) or fulguration (two patients).
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 February 25, 2022.
"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 Mark Schoenberg, M.D., Chief Medical Officer, UroGen. UroGen’s proprietary RTGel technology allows medicines to dwell for several hours potentially improving the therapeutic effects of existing medicines. If approved, UGN-102 would be the only primary non-surgical treatment option for patients with LG-IR-NMIBC who often recur within one year of receiving surgery and continue to need repetitive surgeries for the rest of their life."
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.
Results showed:
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.
About LG-IR-NMIBC
Approximately 800,000 people are living with bladder cancer in the U.S., of that 80,000 suffer from LG-IR-NMIBC. Patients with LG-IR-NMIBC face a future of recurrence and additional surgeries. Currently, the only primary treatment available is a surgical procedure known as transurethral resection of bladder tumor or TURBT, which requires anesthesia. Every time TURBT is performed it may impose more burden and serious risks on patients, including pain, bleeding, infection and injury (including perforation).