In sufferers with low-grade, intermediate-risk NMIBC, UGN-102 generated sturdy, sturdy responses. © inventory.adobe.com.
For sufferers with low-grade, intermediate-risk non-muscle-invasive bladder most cancers (NMIBC), UGN-102 generated sturdy and sturdy responses in an evaluation of the section 3 ENVISION and ATLAS research, in response to findings that have been introduced on the 2025 Genitourinary Cancers Symposium.
Glossary:
Full response: disappearance of all detectable illness following therapy.
Transurethral resection of bladder tumor (TURBT): surgical process to take away bladder tumors by way of the urethra.
Kaplan-Meier estimate: statistical methodology to estimate survival chances over time.
Hematuria: presence of blood in urine.
Micturition urgency: sudden, sturdy have to urinate.
Pollakiuria: abnormally frequent urination.
Urethral stenosis: narrowing of the urethra, resulting in urinary obstruction.
Nocturia: frequent urination at night time.
Malaise: normal feeling of discomfort or unease.
Illness-free survival (DFS): time from therapy to illness recurrence or demise.
Period of response (DOR): size of time a tumor responds to therapy with out development.
Mitomycin-containing reverse thermal hydrogel: temperature-sensitive gel that delivers mitomycin intravesically for bladder most cancers therapy.
Intravesical therapy with UGN-102: non-surgical remedy utilizing a mitomycin-based reverse thermal gel for low-grade bladder most cancers.
Within the single-arm ENVISION trial, 79.6% of sufferers with recurrent illness who obtained UGN-102 (240 sufferers) achieved an entire response (CR) at three months, and the estimated 12-month CR charge was 82.3%.
Within the randomized ATLAS trial, 64.8% of sufferers with newly recognized or recurrent illness who obtained UGN-102 with or with out subsequent transurethral resection of bladder tumor (TURBT; 142 sufferers) achieved a CR at three months versus 63.6% of those that underwent TURBT (140 sufferers). The Kaplan-Meier estimated 12-month CR charges in these respective arms have been 79.7% and 67.7%.
“These outcomes show that therapy with UGN-102 leads to a excessive and clinically significant sturdy CR charge in sufferers with newly recognized or recurrent low-grade, intermediate-risk NMIBC,” lead examine writer Dr. Sandip M. Prasad, of Morristown Medical Heart, Atlantic Medical Group, in New Jersey and coauthors wrote in a poster presentation of the information.
Security Knowledge
The most typical facet impact noticed with UGN-102 throughout each trials was dysuria, which was reported in 22.5% and 30.4% of sufferers who obtained the UGN-102 in ENVISION and ATLAS, respectively.
Beforehand reported security findings from ENVISION confirmed that further treatment-emergent unwanted effects with UGN-102 included hematuria (8.3%), urinary tract an infection (7.1%), pollakiuria (6.7%), fatigue (5.4%), urinary retention (5%), urethral stenosis (4.6%), COVID-19 (3.8%), constipation (3.8%), nausea (3.8%) and micturition urgency (3.3%).
Beforehand reported security findings from ATLAS demonstrated that further treatment-emergent unwanted effects within the UGN-102 and TURBT arms, respectively, included micturition urgency (18%; 7.6%), nocturia (18%; 6.8%), pollakiuria (16%; 6.1%), flatulence (9.4%; 3%), COVID-19 (8.0%; 6.1%), erectile dysfunction (6.5%; 3%), hematuria (6.5%; 4.5%) and malaise (5.8%; 1.5%).
“UGN-102 could signify an efficacious and well-tolerated therapy possibility for sufferers with low-grade, intermediate-risk NMIBC,” the authors wrote within the poster.
Further Up to date Efficacy Findings
Among the many sufferers within the ENVISION and ATLAS trials, respectively, 68% and 60% have been at the least 65 years of age; 98% and 99% have been White; and 61% and 70% have been male.
The median length of response (DOR) was not estimable in any of the three trial arms due to low recurrence charges. In ENVISION, at a median observe up for DOR of 13.86 months, 17.3% of full responders (191 sufferers) had illness recurrence, together with low-grade illness (14.1%) and high-grade illness (2.1%). Two sufferers had died.
Within the UGN-102 arm, at a median follow-up for DOR of 12.45 months, 19.6% of full responders (92 sufferers) had illness recurrence, together with low-grade illness (16.3%) and high-grade illness (3.3%). No sufferers on this arm had died. Within the TURBT arm, at a median follow-up for DOR of 12.16 months, 27% of full responders (89 sufferers) had illness recurrence, together with low-grade illness (19.1%) and high-grade illness (6.7%). One affected person on this arm had died.
ENVISION and ATLAS Background and Design
TURBT is the present customary of care (SOC) for sufferers with low-grade, intermediate-risk NMIBC; nonetheless, the examine authors famous that this therapy methodology gives insufficient illness management and that sufferers usually have to bear a number of TURBTs beneath normal anesthesia, which has related problems, notably for aged sufferers. To handle this want, the ENVISION and ATLAS trials studied the efficacy of intravesical therapy with UGN-102, a mitomycin-containing reverse thermal hydrogel, in sufferers with low-grade, intermediate-risk NMIBC.
In each research, sufferers within the UGN-102 arms obtained UGN-102 by way of a urinary catheter at 75 milligrams as soon as weekly for six months. In ENVISION, sufferers with recurrent illness obtained UGN-102, and people and not using a CR at three months subsequently obtained SOC therapy and entered the follow-up interval. In ATLAS, sufferers with newly recognized or recurrent illness have been randomly assigned to obtain UGN-102 or TURBT. These and not using a CR with residual low-grade illness subsequently obtained TURBT and entered the follow-up interval. All sufferers in each trials have been examined for bladder most cancers recurrence utilizing cystoscopy, urine cytology and for-cause biopsy at three months and at common intervals thereafter.
In ENVISION, the first finish level was CR at three months. In ATLAS, the first finish level was disease-free survival (DFS). Secondary finish factors in each trials included DOR and security.
Notably, beforehand reported findings from ATLAS confirmed that UGN-102 with or with out TURBT generated comparable estimated DFS outcomes for sufferers with newly recognized versus recurrent illness. The estimated 15-month DFS charge with UGN-102 was 77.4% in sufferers with newly recognized illness versus 63.2% in these with recurrent illness.
References:
- “Therapy of Low-Grade Intermediate-Danger Non-Muscle-Invasive Bladder Most cancers With UGN-102: Outcomes of the Part 3 ATLAS and ENVISION Research” by Dr. Prasad S, et al., J Clin Oncol.
- “Response to Main Chemoablation With UGN-102 in Sufferers With New or Recurrent LG IR NMIBC: Put up-Hoc Evaluation of the ATLAS Trial” by Dr. Prasad SM, et al., J Urol.
- “Main Chemoablation of Recurrent Low-Grade Intermediate-Danger Nonmuscle-Invasive Bladder Most cancers With UGN-102: A Single-Arm, Open-Label, Part 3 Trial (ENVISION)” by Dr. Prasad SM, et al., J Urol.
- “Therapy of Low-Grade Intermediate-Danger Nonmuscle-Invasive Bladder Most cancers With UGN-102 ± Transurethral Resection of Bladder Tumor In comparison with Transurethral Resection of Bladder Tumor Monotherapy: A Randomized, Managed, Part 3 Trial (ATLAS)” by Dr. Prasad SM, et al., J Urol.
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