The mitomycin-containing reverse thermal gel UGN-102 with or without TURBT reduced the risk of recurrence, progression, or death vs TURBT alone in patients with low-grade intermediate-risk non-muscle invasive bladder cancer.
Treatment with the mitomycin-containing reverse thermal gel UGN-102 with or without transurethral resection of bladder tumor surgery (TURBT) was shown to improve outcomes vs TURBT alone in patients with low-grade intermediate-risk non–muscle-invasive bladder cancer (LG-IR-NMIBC), according to results from the phase 3 ATLAS trial.1,2
The findings, which were published online in the Journal of Urology, specifically showed that compared with TURBT alone, treating patients with primary, non-surgical chemoablation with UGN-102 with or without subsequent TURBT led to a 55% reduction in the risk of recurrence, progression, or death (event-free survival [EFS]). The EFS rate at 15 months was 72% for patients who received UGN with or without TURBT vs 50% for patients treated with TURBT alone (HR, 0.45).
Additionally, at the first disease assessment 3 months following initiation of treatment, the tumor-free complete response rate was 65% (92 of 142 patients ) for those receiving UGN-102 compared with 64% (89 of 140 patients) for those receiving TURBT.
"While TURBT is the standard treatment for bladder cancer, the recurrent nature of LG-IR-NMIBC means that patients will undergo multiple surgeries that come with risks for this older patient population," Sandip Prasad, MD, MPhil, director of genitourinary surgical oncology, Morristown Medical Center/Atlantic Health System, NJ, and chief investigator in the ATLAS trial, stated in a press release. "It is exciting to consider what a potential non-surgical therapeutic alternative could mean for both patients and doctors who are eager for additional options."1
Overall, the open-label trial enrolled 282 patients with newly diagnosed or recurrent LG-IR-NMIBC. Patients were randomized in a 1:1 ratio to receive UGN-102 with or without TURBT (n = 142) or TURBT alone (n = 140).
The median patient age was 68 years (range, 23-85) in the UGN-102 arm and 67 years (range, 29-88) in patients receiving TURBT alone. The majority of patients in both arms were male at 74% and 66%, respectively. Almost all patients in both arms were White.
Forty-seven percent of patients in the UGN-102 arm had a tumor size >3 cm compared with 42% in the control arm. Fifty-eight percent and 67% of the 2 arms, respectively, had multiple tumors. A prior history of LG NMIBC was reported for 38% of the UGN-102 arm and 46% of the control arm, with 29% of patients in both arms having LG NMIBC within <1 year of study enrollment. Thirty-seven percent and 46% of the 2 arms, respectively, had prior TURBT.
Regarding safety, treatment-emergent adverse events (TRAEs) occurring in at least 10% of the UGN-102 group were dysuria (30%), micturition urgency (18%), nocturia (18%), and pollakiuria (16%). TEAEs led to treatment discontinuation in 5 patients in the UGN-102 arm.
The researchers noted in their manuscript that, “Patient-reported symptoms, functioning, and quality-of-life—as measured by changes from baseline in the EORTC-QLQ-NMIBC24—either were improved or not worsened in those treated with UGN-102 ± TURBT or TURBT alone.”
Commenting on the results in a press release, Mark Schoenberg, MD, chief medical officer at UroGen, the developer of UGN-102, stated, “The publication of our ATLAS data in The Journal of Urology adds another chapter to our understanding of the potential of UGN-102 as a treatment for patients with LG-IR-NMIBC, who often face multiple surgeries due to the recurring nature of this cancer. Our hope is that one day urologists may have an effective, non-surgical therapy option beyond TURBT that can be used to address this large patient population.”1
1. The Journal of Urology Publishes Peer-Reviewed Article Highlighting UGN-102 Data in Non-Surgical Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer. Published online and accessed August 8, 2023. https://finance.yahoo.com/news/journal-urology-publishes-peer-reviewed-120000965.html
2. Prasad SM, Huang WC, Shore ND, et al. Treatment of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer with UGN-102 ± Transurethral Resection of Bladder Tumor (TURBT) Compared to TURBT Monotherapy: A Randomized, Controlled, Phase 3 Trial (ATLAS) [published online ahead of print August 7, 2023]. J Urol. doi: 10.1097/JU.0000000000003645