David Morris, MD, FACS1; Eugene V. Kramolowsky, MD, MSHA2; M. Vincent Bivins, MD, FACS3; Michael J. Louie, MD, MPH, MSc4; Sunil Raju, MBBS4; Brent Burger, MSc, MBA4; Andrew Meads, BS4; Mark Schoenberg, MD, FACS4,5
1Urology Associates PC, Nashville, Tennessee
2Virginia Urology, Richmond, Virginia
3Urology Centers of Alabama, Alabama
4UroGen Pharma, Princeton, New Jersey
5Department of Urology, Montefiore Medical Center, Einstein Campus, Bronx, New York
KEYWORDS:
Urinary bladder neoplasms; non-muscle invasive bladder neoplasms; mitomycin; patient care
Abstract
Background: UGN-102 is a reverse thermal gel that contains 75 mg mitomycin, administered as a course of 6 once-weekly intravesical instillations via urinary catheter. UGN-102 is in development as a treatment for lowgrade, intermediate-risk non–muscle-invasive bladder cancer (NMIBC). This study investigated the feasibility of administering UGN-102 in patients’ homes instead of an outpatient clinical setting.
Methods: Clinical trial BL010 (ClinicalTrials.gov identifier NCT05136898) was a single-arm, phase 3b, open-label, multicenter study. Its primary end point was the feasibility of home instillations with UGN-102, evaluated by safety assessments and questionnaires for patients, trained home health professionals, and investigators. A qualified physician performed the first instillation at the investigative site; the 5 subsequent instillations were administered at home by home health professionals. The secondary efficacy end point was complete response at 3 months, as determined by cystoscopy, urine cytology, and for-cause biopsy.
Results: Eight patients with low-grade, intermediate-risk NMIBC (median age, 75 years; 62.5% male) were enrolled, of whom 6 (75.0%) completed all instillations. Two patients discontinued treatment and the study early due to non–treatment-related adverse events (classified as nonresponders). Five of the 6 patients who completed treatment would recommend home instillation of UGN-102 for other patients with NMIBC. Home health professionals were comfortable performing home instillations. Investigators reported home instillation as “not different” from office instillation for 5 of the 8 patients (62.5%). Six (75.0%) patients achieved complete response (95% CI, 34.9-96.8) at 3 months. Some patients experienced mild to moderate urinary symptoms.
Conclusions: Home instillation of UGN-102 is feasible, safe, and effective for patients with low-grade, intermediate-risk NMIBC.
Bladder cancer accounts for approximately 4% of all cancers in the United States, with approximately 83 000 new cases diagnosed annually.1 At diagnosis, roughly 90% of bladder cancers are confined to the bladder wall, of which about 75% are non–muscle-invasive bladder cancer (NMIBC),2-5 a group of bladder tumors that have not invaded the muscle cell wall of the bladder but rather are confined to the mucosa; they consist of Ta (noninvasive) and T1 (invading the subepithelial connective tissue) papillary tumors and carcinoma in situ.6 Current treatment guidelines recommend stratifying patients with NMIBC according to risk (low-risk, intermediate-risk, or high-risk disease) based on clinical and pathologic factors.6
Intermediate-risk NMIBC is defined by the International Bladder Cancer Group as multiple or recurrent low-grade Ta tumors in which 1 or 2 of the following factors are present: more than 1 tumor; size of tumors larger than 3 cm; disease recurrence within 1 year or more than 1 recurrence per year; and previous treatment regimens, such as intravesical BCG or chemotherapy.7,8 Low-grade, intermediate-risk NIMBC is a chronically relapsing disease, and the standard of care for its treatment is transurethral resection of bladder tumor (TURBT) under general anesthesia.9,10 Postoperative intravesical chemotherapy or BCG therapy are also recommended for some patients with intermediaterisk disease.3,4,6 For select patients, more conservative approaches may be considered, including office fulguration, laser therapy, chemoresection, and expectant management.4
UGN-102 is a reverse thermal gel that contains mitomycin; it is currently administered via intravesical instillation in the outpatient setting. The UGN-102 therapy remains a liquid in chilled conditions and solidifies at body temperature to form a localized drug depot, enabling high concentrations of mitomycin at tumor sites with minimal systemic absorption. UGN-102 has been developed as a nonsurgical treatment option for low-grade, intermediate-risk NMIBC. Recent experience demonstrates that many patients with low-grade, intermediate-risk NMIBC can be successfully treated with UGN-102, decreasing the need for TURBT under general anesthesia.11,12 In the phase 3 ENVISION study of UGN-102 for treatment of low-grade, intermediate-risk NMIBC (ClinicalTrials. gov identifier NCT05243550), the complete response (CR) rate at 3 months was 79.6%, with an 82.3% probability of remaining in CR at 12 months based on Kaplan-Meier estimate.12
Here, we report the results of a study examining the feasibility, safety, and efficacy of administering UGN-102 in the home setting for the treatment of low-grade, intermediate-risk NMIBC.
Clinical study BL010 (ClinicalTrials.gov identifier NCT05136898) was a single-arm, phase 3b, openlabel, multicenter study to evaluate the feasibility of home instillation of UGN-102 for the treatment of low-grade, intermediate-risk NMIBC. The study was conducted across 5 sites in the United States between November 30, 2021, and February 2, 2023.
Eligible patients were 18 years of age or older with recurrent low-grade, intermediate-risk NMIBC (Ta) histologically confirmed by cold-cup biopsy at the screening visit or within the 8 weeks before the screening visit. Intermediate-risk disease was defined as 1 or 2 of the following: the presence of multiple tumors, a solitary tumor larger than 3 cm, or early or frequent recurrence of disease (defined as ≥1 occurrence of low-grade NIMBC within 1 year of the current diagnosis at the initial screening visit). All patients had negative voiding cytology for high-grade disease within the 6 weeks before the screening visit. Exclusion criteria included BCG treatment for urothelial carcinoma within the previous year; a history of high-grade bladder cancer (papillary or carcinoma in situ) in the past 2 years; and known allergy or sensitivity to mitomycin that, in the investigator’s opinion, could not be readily managed.
Each study participant provided written informed consent. The trial protocol, amendments, and informed consent form were approved by the institutional review board or independent ethics committee at each participating site. BL010 was conducted in compliance with ethical principles of the Declaration of Helsinki, International Council for Harmonisation guidelines, and 21 USC §50 and 312. The study was registered with ClinicalTrials.gov (NCT05136898).
Six once-weekly intravesical instillations of UGN-102 (75 mg mitomycin in 56 mL admixture) were planned for all patients. The first instillation was performed at the investigative site by a qualified physician. The 5 subsequent instillations were performed at the patient’s home by a trained and qualified home health professional (HHP); an assigned courier obtained the prepared UGN-102 admixture from the site’s pharmacy, then delivered the instillation to the qualified HHP at the patient’s home. The HHP disposed of used study treatment vials according to local institution guidelines for cytotoxic waste destruction, and disposal was documented on a drug disposal form. Each patient was monitored for adverse events (AEs) during and for at least 60 minutes after each study treatment instillation. The HHP telephoned the patient on day 1 after each home instillation to further monitor for safety. Following the month 3 visit, all patients exited the study and continued with care according to their treating physician.
Home instillation feasibility questionnaires were completed by the patient (Supplementary Table 1), the HHP (Supplementary Methods), and the investigator (Supplementary Methods), according to a predetermined schedule.
Patients rated their experience regarding home instillation of UGN-102 after each instillation and at the month 3, end-of-study, or early termination visit. Patients were asked to rate their experience of receiving UGN-102 at home with respect to comfort, safety, communication, and preference compared with office instillation as well as their overall experience after each instillation.
The patient questionnaire consisted of 8 questions to determine 5 domain scores and a single composite score:
Domain scores:
– Comfort domain score. Based on 3 questions; scores ranged from 3 (“Least favorable”) to 12 (“Most favorable”)
– Safety domain score. Based on 1 question; scores ranged from 1 (“Least favorable”) to 4 (“Most favorable”)
– Communication domain score. Based on 2 questions; scores ranged from 2 (“Least favorable”) to 8 (“Most favorable”)
– Preference domain score. Based on 1 question; scores ranged from 1 (“Least favorable”) to 4 (“Most favorable”)
– Overall experience domain score. Based on 1 question; scores ranged from 1 (“Least favorable”) to 4 (“Most favorable”)
Composite score:
– Based on all 8 domain questions; scores ranged from 8 (“Least favorable”) to 32 (“Most favorable”)
At the end-of-study or early termination visit, patients were also asked to complete the patient end-of-study questionnaire, which consisted of 2 yes-or-no questions:
Would you recommend home instillations of UGN-102 for other patients with NMIBC?
Would you recommend home instillations of UGN-102 instead of having TURBT?
Home health professionals were asked to share their experience of administering UGN-102 at the patient’s home with respect to comfort, difficulty, concerns, and adequacy of support provided to the HHP after completion of each instillation. For each patient, the same HHP administered all instillations.
The HHP questionnaire consisted of 4 yes-or-no questions:
Were you comfortable performing the instillation at this patient’s home?
Was it difficult to perform the instillation at this patient’s home?
Did you have any concerns about performing the instillation in the home setting?
Did you have sufficient support performing the instillation in the home setting?
At the end of the study, investigators were asked to share their experience of having patients receive UGN-102 at home with respect to difficulty and overall experience. The investigator questionnaire consisted of a single question with the possible answers “More difficult,” “Less difficult,” and “Not different”: “Please share your experience of having the patient receive instillations at home rather than in office.”
The primary study outcome was assessment of the feasibility of home instillation in terms of safety, tolerability, and rate of discontinuation from home treatment. Feedback from patients, HHPs, and investigators was collected using standardized questionnaires. Safety outcomes (AEs) were recorded from the time of informed consent through the month 3 visit.
The secondary study outcome was the efficacy of UGN-102, as assessed by CR rate at 3 months after the start of treatment and determined by endoscopic evaluation, urine cytology, and for-cause biopsy. Complete response was defined as no detectable disease in the bladder. To determine no detectable disease, the following conditions had to be fulfilled:
If visual assessment indicated no remaining tumors and urine cytology was not consistent with the presence of urothelial carcinoma, the patient had no detectable disease and CR.
If any lesions were visualized, even if they appeared necrotic, the physician was to biopsy the lesions. If histopathology was negative, the patient was classified as CR; if histopathology was positive for cancer, the patient was classified as non-CR.
The safety analysis set (all patients who received any dose of UGN-102) served as the primary population for all analyses of safety and efficacy data in this study. The scoring method of the patient questionnaire consisted of a calculation of a raw total score. Each domain score (eg, Comfort [question (Q)1 + Q2 + Q3], Safety [Q4], Communication [Q5 + Q6], Preference [Q7], and Overall Experience [Q8]) was calculated based on the previously described scoring method. A composite score (the sum of all 8 domain scores) was also calculated. For each question, a higher score reflected a more favorable response. For the HHP and investigator questionnaires, responses were summarized by frequencies and percentages.
The CR rate was defined as the proportion of patients in the safety population who achieved CR at the month 3 disease assessment, as determined by cystoscopy, for-cause biopsy, and urine cytology. If a patient terminated the study before the month 3 visit, that patient was considered to have non-CR and was included in the denominator to calculate the CR rate. The CR rate is presented with 95% CIs. A test for binomial proportions was used to derive the exact 2-sided 95% CI for the CR rate using the Clopper-Pearson method.
Adverse events were summarized by number and percentage of patients having at least 1 AE, having at least 1 AE in each primary system organ class, and for each preferred term using the Medical Dictionary for Regulatory Activities coding. A patient with multiple occurrences of an AE was counted only once in the respective AE category.
Nine participants with low-grade, intermediate-risk NMIBC met eligibility criteria and were enrolled; of these 9 participants, 8 received treatment with UGN-102. Of these 8 recipients, 6 (75.0%) completed study treatment (6 instillations) and 2 (25.0%) discontinued treatment and the study early due to non– treatment-related AEs. The median age of treated patients was 75 years (range, 55-84 years), 5 (62.5%) patients were male, all patients were White, and all patients had prior low-grade NMIBC and had previously undergone TURBT (median number of prior TURBTs, 4.0 [range, 1-7]) (Table 1). The medical history data reflect multiple comorbidities in the study population, including hypertension (5/8 [62.5%]); anxiety (4/8 [50.0%]); cataracts (3/8 [37.5%]); and abdominal discomfort, back pain, basal cell carcinoma, benign prostatic hyperplasia, depression, drug hypersensitivity, gastroesophageal reflux disease, hypercholesterolemia, hypothyroidism, and sleep apnea in 2 patients (25.0%) each. Five (62.5%) patients had multiple tumors, and 4 (50.0%) had masses with a tumor size greater than 3 cm (Table 1).
For each domain of the patient questionnaire, patients rated their home instillation experience highly, and median values remained the same throughout the treatment period, indicating that patients had no change in their home instillation experience over time. Detailed outcomes are summarized in Table 2. At each assessment, the median Comfort domain score was 12.0 (range, 10-12), the median Safety domain score was 4.0 (range, 3-4), the median Communication domain score was 8.0 (range, 6-8), the median Preference domain score was 4.0 (range, 2-4), the median Overall Experience domain score was 4.0 (range, 3-4), and the median Composite score was 32.0 (range, 26-32).
Detailed outcomes of the HHP questionnaire responses are presented in Table 3. The HHPs reported that they were comfortable administering the instillation, did not have difficulty or concerns when performing the instillation, and had sufficient support to provide the instillation within the home setting for 34 of 37 (91.9%) instillations. Detailed outcomes of the investigator and patient end-of-study questionnaires are presented in Table 4. Of the available responses, 5 of 6 (83.3%) patients stated that they would recommend home instillations of UGN-102 for other patients with NMIBC and that they would recommend home instillations of UGN-102 as an alternative to TURBT. One patient did not recommend home instillations of UGN-102 for other patients with NMIBC and clarified that they would not recommend home instillations if the risk of going under anesthesia (presumably for TURBT) on their health was low.
The investigators completed the investigator end-ofstudy questionnaire for all patients except the 2 patients who discontinued (Table 4). Four investigators participated in the study. The investigators found home instillation “not different” to office instillation for 62.5% of the overall safety set and for 5 of the 6 (83.3%) patients who completed the study. For 1 patient, the investigator found home instillation “more difficult” due to “coordination of care” and “delivery of product.” Although the majority of the UGN-102 admixture was delivered directly to the qualified HHP at the patient’s home for instillation, 1 labeled drug lot was dispensed to a patient in the study.
At the month 3 visit, 6 of the 8 (75.0%) participants achieved the secondary efficacy end point, CR (95% CI, 34.9-96.8). The remaining 2 (25.0%) patients who discontinued were considered nonresponders.
Overall, 8 (100%) patients had at least 1 treatmentemergent AE (TEAE) (Table 5); most were considered mild to moderate and resolved or resolving. Four (50.0%) patients had at least 1 treatment-related TEAE (TEAEs that occurred in >1 patient were dysuria and fatigue, in 2 [25.0%] patients each), while 1 (12.5%) patient experienced 3 procedurerelated TEAEs (hematuria, micturition urgency, and pollakiuria). A total of 3 (37.5%) patients had at least 1 serious TEAE (pleural effusion, cerebrovascular accident and intracranial aneurysm, embolic stroke), none of which was considered related to the study treatment or procedure. No patients died during the study. Two (25.0%) patients discontinued treatment and the study early due to non–treatment-related AEs: 1 patient had a cerebrovascular accident and intracranial aneurysm that were considered serious and of a severe intensity, not related to treatment or procedure, while the second patient experienced serious pleural effusion of a severe intensity, although the event was considered not related to the study treatment or procedure.
BL010 was an open-label, single-arm, multicenter phase 3b trial to assess the feasibility of home instillation of UGN-102 (mitomycin) for the treatment of recurrent low-grade, intermediate-risk NMIBC. Patients with this highly persistent and recurrent disease typically undergo treatment with repeated TURBT under general anesthesia.2,4 The totality of the evidence, including procedural limitations (eg, incomplete resection of tumors, complications of TURBT and general anesthesia, and the high recurrence rate of NMIBC), suggests that the current, primarily surgical standard of care for recurrent low-grade, intermediate-risk NMIBC is suboptimal.10,13,14 UGN-102 has a potentially ablative effect for well-selected patients with NMIBC that can lead to a reduction in the need for TURBT under general anesthesia.10,15
UGN-102 was developed as a nonsurgical alternative to TURBT, the current standard of care.11,12 It is a reverse thermal gel that contains mitomycin and can be administered via intravesical instillation in the outpatient setting, without the need for surgery.11,12 The results of recent studies have shown that many patients with low-grade, intermediate-risk NMIBC can be successfully treated with UGN-102,11,12 and the gel has demonstrated robust, clinically meaningful CR rates at 3 months (79.6%), with an 82.3% probability of durable response at 12 months based on Kaplan-Meier estimate.12
Patients with low-grade, intermediate-risk NMIBC are generally older and have a high comorbidity burden, as we observed in previous UGN-102 studies; these patients are currently treated with repeated cycles of TURBT under general anesthesia.11,12 We sought to test the feasibility of home instillation of UGN-102 after 1 instillation had been successfully administered in the clinical setting. The results of feedback questionnaires and safety assessments indicated that home instillation of UGN-102 was feasible for treatment of patients with low-grade, intermediaterisk NMIBC. Based on the patient questionnaire, patients rated their home instillation experience highly and had no change in their home instillation experience over the course of the study. Home health professionals reported that they were comfortable performing the instillation, did not have difficulty with or concerns about the instillation procedure, and had sufficient support to perform the instillation in the home setting for 91.9% of instillations. At the end of the study, most patients who responded to the patient questionnaire stated that they would recommend home instillation of UGN-102 for other patients with NMIBC and would recommend home instillation of UGN-102 in preference to TURBT. Furthermore, in the 6 patients who completed the study, the investigators found home instillation to be “not different” to office instillation for 5 patients and “more difficult” for only 1 patient (due to coordination of care and product delivery).
A CR at 3 months was achieved in all patients who completed the study. There was no subsequent follow-up for durability in this study. The overall safety profile of UGN-102 was consistent with previous studies and primarily characterized by mild to moderate urinary symptoms.11,12
UGN-102 instillation is a minimally invasive procedure that eliminates the need for general anesthesia and reduces the risk of adverse effects associated with TURBT. Administering UGN-102 in the home setting could be more convenient for patients and alleviate the financial burden associated with travel to attend office or clinic appointments. Furthermore, home administration could be advantageous for health care professionals, contributing to improved workflow and freeing up facilities, such as exam rooms.
This study has several limitations, including the small sample size of 8 patients and its open-label, single-arm design. In addition, the included patients were not ethnically or racially diverse; thus, results may not be replicated in the general population. Future studies encompassing a broader patient population and extended follow-up periods would provide more comprehensive insights.
Results from this small feasibility study demonstrate that home instillation of the chemoablation agent UGN-102 for the treatment of low-grade, intermediate-risk NMIBC by HHPs is safe and effective, demonstrating a high, clinically meaningful CR rate. The overall safety profile was characterized primarily by mild to moderate urinary symptoms. Home instillation of UGN-102 may provide patients with an alternative to in-clinic instillation, reducing the treatment burden associated with low-grade, intermediate-risk NMIBC.
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Published: June 23, 2025.
Conflict of Interest Disclosures: D. Morris is a consultant or advisor to Astellas, AstraZeneca, Bayer, Blue Earth Diagnostics, Cleveland Diagnostics, Decipher Biosciences, Dendreon, Janssen, Lantheus, Myriad, Merck, Myovant, Tolmar, UroGen Pharma; is on the advisory board of Pfizer; and has an ownership or investment interest in UroGPO. E. V. Kramolowsky and M. V. Bivins are investigators for UroGen Pharma. M. J. Louie, S. Raju, B. Burger, A. Meads, and M. Schoenberg are employees of UroGen Pharma and may hold stock and/or stock options in the company.
Funding/Support: This study was sponsored by UroGen Pharma, which was involved in the study design, data analysis, and review of the manuscript. Medical writing and editorial assistance were provided by Excerpta Medica, which was funded by UroGen Pharma.
Author Contributions: D. Morris: Conceptualization, Data curation, Writing—review & editing. E. V. Kramolowsky: Conceptualization, Data curation, Writing—review & editing. M. V. Bivins: Writing—review & editing. M. J. Louie: Project administration, Writing—review & editing, Supervision. S. Raju: Methodology, Writing—review & editing, Validation, Investigation, Visualization. B. Burger: Formal analysis, Writing—review & editing, Validation. A. Meads: Validation, Writing—review & editing. M. Schoenberg: Methodology, Writing—review & editing.
Data Availability Statement: The datasets generated or analyzed during the current study are available from the corresponding author on reasonable request.
Acknowledgments: We thank the investigators, HHPs, and patients who participated in this study. Medical writing/editorial assistance was provided by Patrick Crowley, PhD, and Jaqui Hodgkinson, DPhil, MBA, of Excerpta Medica, funded by UroGen Pharma in accordance with current Good Publication Practice guidelines.
Supplementary Material: Supplementary material is available at Reviews in Urology online.
Citation: Morris D, Kramolowsky EV, Bivins MV, et al. Home instillation of UGN-102 for primary chemoablation of recurrent, low-grade, intermediaterisk non–muscle-invasive bladder cancer: a single-arm, open-label, phase 3b trial. Rev Urol. 2025;24(2):e95-e106.
Corresponding author: David Morris, MD, FACS, Urology Associates PC, 2801 Charlotte Ave, Nashville, TN 37209 (dsmorris@ua-pc.com)