Up to 60 percent of people with non–muscle-invasive bladder cancer will have the cancer return after initial treatment. The standard of care for patients with non–muscle-invasive bladder cancer is surgical removal of the tumors. Surgery, however, can be associated with complications, especially for patients with bladder cancer who are typically in their 70s and 80s. William C. Huang, MD, a urologic oncologist at NYU Langone Health’s Perlmutter Cancer Center, is the Perlmutter Cancer Center lead of the phase 3 ENVISION study, a single-arm clinical trial in which people with intermediate-risk, low-grade, non–muscle-invasive bladder cancer will be treated with UGN-102—a reverse thermogelation hydrogel containing the chemotherapy mitomycin—as a primary way of chemoablating bladder tumors instead of surgically removing them.
“We think UGN-102 could be a paradigm-changing method of treating some bladder cancers,” says Dr. Huang, professor of in the Departments of Urology and Radiology at NYU Grossman School of Medicine. “We feel that UGN-102 will be a unique and safe way of delivering treatment for patients with bladder cancer, especially those who are older and sicker and who might not be good candidates to have surgery.”
UGN-102 is an intravesical treatment —the hydrogel is injected directly into the bladder. When the hydrogel is cold, it is a liquid, but as it warms up to body temperature, it becomes a solid, enabling the mitomycin to come into contact with tumor cells for up to six hours.
The ENVISION study expands the earlier phase 2b OPTIMA II trial, in which 41 of the 63 patients—65 percent—achieved a complete response at the 3-month follow-up from the start of treatment. Dr. Huang says most of the patients in the OPTIMA II study had on average up to four or five previous recurrences of the cancer. UGN-102 not only removed or ablated the tumor that was treated, but it also prevented the recurrence of new tumors. Of those 41 patients who achieved a complete response, 25 (61 percent) were disease-free 12 months after starting treatment.
“From my point of view, because the hydrogel is treating the entire bladder, we are also treating the tumors that have not yet become visible,” says Dr. Huang, who is also chief of the urology service at NYU Langone’s Tisch Hospital. “Since UGN-102 treats tumors in the bladder and prevents recurrences, it represents a treatment method that can spare these patients repeated trips to the operating room.”
As in the OPTIMA II trial, people enrolled in the ENVISION study will receive six once-weekly intravesical instillations of UGN-102. The ENVISION study plans to enroll 220 people across 90 sites, with the rate of complete response 3 months after the initial treatment as the primary end point and the durability of these complete responses as the secondary end point.
Dr. Huang leads the trial at Perlmutter Cancer Center in Manhattan. The trial is also open at Perlmutter Cancer Center at NYU Langone Hospital—Long Island, where the site principal investigator is Anthony Corcoran, MD, a clinical assistant professor in the Department of Urology at NYU Long Island School of Medicine and director of urologic oncology at NYU Langone Hospital—Long Island.