The phase 3 ATLAS study demonstrated the superiority of UGN-102 (mitomycin) compared with transurethral resection of bladder tumor (TURBT) surgery for patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC).
Results of the study—led by Sandip M. Prasad, MD, of Atlantic Health System and Garden State Urology—were published in The Journal of Urology.
Dr. Sandip and colleagues designed a prospective analysis to compare the safety and efficacy of UGN-102—a reverse thermal gel containing mitomycin—with or without TURBT versus TURBT alone in patients with low-grade, intermediate-risk NMIBC. A total of 282 patients were randomized to receive UGN-102 (n=142) or TURBT monotherapy (n=140). The primary end point was disease-free survival (DFS), and all patients were followed for adverse events (AEs).
Results showed that tumor-free complete response after 3 months of treatment was achieved by 65% (n=92) and 64% (n=89) of patients, respectively. Researchers noted that the estimated probability of DFS after 15 months was 72% versus 50%, respectively (hazard ratio, 0.45).
They added that UGN-102 was generally well-tolerated, with an AEs profile similar to that of previous clinical trials. The most common AEs in the UGN-102 arm were dysuria, micturition urgency, nocturia, and pollakiuria.
“While TURBT is the standard treatment for bladder cancer, the recurrent nature of low-grade, intermediate-risk NMIBC means that patients will undergo multiple surgeries that come with risks for this older patient population,” said Dr. Prasad said in a press release. “It is exciting to consider what a potential nonsurgical therapeutic alternative could mean for both patients and doctors who are eager for additional options.”
UGN-102 is also being investigated as a primary chemoablative therapy for patients with low-grade, intermediate-risk NMIBC in the ENVISION trial. Topline data show that the trial met its primary end point; patients treated with UGN-102 had a 79.2% rate of complete response after 3 months of treatment. Further data on duration of response are expected to be announced in 2024.