UGN-102 improves on current standard in low-grade intermediate-risk NMIBC

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

"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," said Sandip Prasad, MD, MPhil, chief investigator in the ATLAS trial.

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

References

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