Benign Conditions

Benign Prostatic Hyperplasia

Bladder Cancer

Female Urology

Genitourinary Cancers

Genomic Testing

Hormone Therapy

Kidney Cancer

Challenging Anatomy

Innovative Techniques

Laser Lithotripsy

PCNL Tech & Devices

Ureteroscopy Tech & Devices

Kidney Stones

Men's Health

Next-Generation Imaging

Voiding Dysfunction

OAB and Incontinence

Pediatrics

Controveries in Urologic Cancer

Drug Therapy

Prostate Cancer

Sexual Dysfunction

UTUC

Cosmetic Surgery

Urologic Surgery

Business

Practice Management

Malpractice Consult

Health Law & Policy

Media

Case-Based Peer Perspectives

Investigator Perspectives 

Medical World News

Podcasts

Urology Medical Perspectives

UTv Videos

Peer Exchange

Special Report

Virtual Tumor Board

Insights

Medcast

Peers & Perspectives

Conferences

Conference Listing

Conference Previews 

Conference Recaps

Publications

Urology Times Journal

Editorial Advisory Board

Urologists in Cancer Care

Supplements and Featured Publications

Clinical Forums Recaps

CME/CE

Resources

Begin Your Journey: Tackling Burnout

Live Events

Interactive Tools

Job Board

Partners

Treatment Landscape Evolutions

Subscribe

Articles

The approval is supported by results from the phase 3 NIAGARA trial.

FDA approves durvalumab/chemo for muscle–invasive bladder cancer

The approval is supported by positive data from the phase 3 PSMAfore trial.

FDA approves expanded label for 177Lu-PSMA-617 in mCRPC

The test can deliver diagnostic results for chlamydia, gonorrhea, and trichomoniasis.

FDA grants marketing authorization to at-home diagnostic test for STIs

“Our results show that by using NeuroSAFE, nearly twice as many men don’t have to face potentially life-changing loss of erectile function after prostate surgery,” says Professor Greg L. Shaw. 

NeuroSAFE procedure for RARP leads to improved erectile function

Urology Times is the leading resource for urologists & allied health professionals offering clinical analysis, policy perspectives, & practical advice.

About Us

Advertise

Editorial

Contact Us

Terms and Conditions

Privacy

Do not sell my Personnal Information

Urology Times | News & Insights for Urologists & Health Professionals

Facebook

LinkedIn

Spotlight

Peers and Perspectives

Clinical

1rem

Authors

There have been several recent regulatory updates related to cybersecurity in health care. 

Expert highlights cybersecurity regulation updates for health care organizations

Dr. De La Cerda provides an overview of a patient case involving a 68 year-old male presenting with severe back pain, with an analysis of the clinical presentation, workup, and medical history.

Bone Predominant mCRPC Patient Case

Video content above is prompted by the following:

What are your initial impressions of the case?

Video Series

The FDA has accepted a Biologics License Application (BLA) seeking approval of nivolumab (Opdivo) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20), or subcutaneous nivolumab, for the treatment of patients with all previously approved solid tumor indications for nivolumab as a monotherapy, monotherapy maintenance following completion of combination therapy with nivolumab plus ipilimumab (Yervoy), or in combination with chemotherapy or cabozantinib (Cabometyx).

Nivolumab is currently approved under several indications, including in combination with ipilimumab for the first-line treatment of patients with intermediate- or poor-risk advanced renal cell carcinoma (RCC), in combination with cabozantinib for the first-line treatment of patients with advanced RCC, for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy, and in combination with cisplatin and gemcitabine for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma.

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024.

 According to a news release from Bristol Myers Squibb,

 approval of the formulation would make it the first and only subcutaneously administered PD-1 inhibitor.

“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” said Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, in the news release.

 “Opdivo is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority. If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV Opdivo but with the improved convenience of an injection administered in 3 to 5 minutes rather than a 30-to-60-minute infusion.”

The BLA submission is supported by findings from the phase 3 CheckMate-67T trial (NCT04810078), in which subcutaneous nivolumab met the study’s co-primary end points by demonstrating noninferiority to intravenous (IV) nivolumab regarding time average nivolumab serum concentration over 28 days (C

; geometric mean ratio [GMR}, 2.098; 90% CI, 2.001-2.200) and minimum serum concentration at a steady state (C

Data from the study, which were presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California,

 also showed that subcutaneous nivolumab demonstrated noninferiority to IV nivolumab in the key powered secondary end point of objective response rate (ORR). Specifically, the subcutaneous arm demonstrated an ORR of 24.2% (95% CI, 19.0-30.0) per blinded independent central review (BICR), compared with 18.2% (95% CI, 13.6-23.6) in the IV arm.

The safety profile for subcutaneous nivolumab was consistent with that of the IV formulation. Among patients who received the subcutaneous formulation, 8.1% experienced injection-site reactions, with all being low-grade and transient. Deaths due to study drug toxicity occurred in 3 patients in the subcutaneous arm and 1 patient in the IV arm. Most deaths that occurred during the study were due to disease progression.

In total, the phase 3, open-label CheckMate-67T trial enrolled 495 patients with advanced or metastatic ccRCC who had received prior systemic therapy. Patients were randomly assigned 1:1 to receive 1200 mg subcutaneous nivolumab plus rHuPH20 every 4 weeks (n = 248) or to 3 mg/kg IV nivolumab every 2 weeks (n = 247) for up to 2 years of treatment or until disease progression, unacceptable toxicity, withdrawal, or death.

The co-primary pharmacokinetic end points for noninferiority testing were C

 of subcutaneous nivolumab vs IV nivolumab. The key secondary end point was ORR per BICR.

Final completion of the CheckMate-67T study is expected in January 2026.

1. U.S. Food and Drug Administration accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Bristol Myers Squibb. May 6, 2024. Accessed May 7, 2024. https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

2. Bristol Myers Squibb announces updated action date by the U.S. Food and Drug Administration for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Published online and accessed May 21, 2024. https://investors.bms.com/iframes/press-releases/press-release-details/2024/Bristol-Myers-Squibb-Announces-Updated-Action-Date-by-the-U.S.-Food-and-Drug-Administration-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

3. George S, Bourlon TB, Chacon MR, et al. Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T. 

4. A study of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread (CheckMate-67T). ClinicalTrials.gov. Last updated March 1, 2024. Accessed May 7, 2024. https://clinicaltrials.gov/study/NCT04810078

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024. 

News

FDA accepts BLA for subcutaneous nivolumab in solid tumors

Real-world data indicate a significantly lower incidence of all-cause bowel disorders in patients with prostate cancer who received radiotherapy treatment along with placement of a polyethylene glycol-based hydrogel spacer (spaceOAR) vs patients who did not receive a spacer.

®, Michael R. Folkert, MD, PhD, explained, “What we were doing with this study is we were trying to look at real-world data for spacer use. We have a lot of prospective data to guide us in in our care of patients, but it's nice to see what happens when you actually apply it to real patients.” Folkert is a professor of radiation oncology at the University of Washington School of Medicine, Seattle.

For the study, Folkert and his colleagues evaluated data on patients from 4 separate data sets: Medicare 5% Standard Analytic Files, Medicare 100% Standard Analytic Files, Merative MarketScan Commercial Database, and Premier Healthcare Database. Patients with prostate cancer who were treated with radiotherapy between 2015 and 2021 were included in the analysis.

“From those data sets, we were able to extract a range of codes for disorders and procedures that were related to bowel complaints to bowel disorders, and then conducted an analysis to probe associations between these codes and the use of rectal spacers, and then a comparison also of disorders and procedures the same sets of disorders and procedures related to bowel complaints and disorders on an age-matched general population that didn't have prostate cancer, to kind of ground the that experience in a general population,” Folkert said.

Regarding their findings, “4 years following radiation therapy, there is a 25% lower hazard of bowel disorders and a 46% lower hazard of related procedures [in patients who received a spacer],” Folkert said.  

1. Folkert MR, Sato R, Yu JB, et al. Bowel disorder incidence and rectal spacer use in patients with prostate cancer undergoing radiotherapy. 

. 2025;8(3):e250491. doi:10.1001/jamanetworkopen.2025.0491

A study evaluated the impact of polyethylene glycol-based hydrogel spacers on bowel disorder incidence in prostate cancer patients undergoing radiotherapy. Using real-world data from multiple databases, researchers found that patients with spacers experienced significantly lower rates of bowel disorders and related procedures compared to those without spacers. Specifically, there was a 25% reduction in the hazard of bowel disorders and a 46% reduction in related procedures four years post-radiotherapy. This study highlights the potential benefits of spacer use in reducing bowel complications in prostate cancer treatment.

"4 years following radiation therapy, there is a 25% lower hazard of bowel disorders and a 46% lower hazard of related procedures [in patients who received a spacer],” says Michael R. Folkert, MD, PhD.

Michael R. Folkert, MD, PhD, discusses real-world outcomes with spacer in prostate cancer

Updated data from the phase 3 BOND-003 trial (NCT04452591) continue to support the efficacy, safety, and tolerability of cretostimogene grenadenorepvec in patients with high-risk BCG-unresponsive non–muscle invasive bladder cancer (NMIBC).

The data were presented by Trinity J. Bivalacqua, MD, PhD, at the 40th Annual European Association of Urology Congress in Madrid, Spain.

Overall, updated efficacy data showed a complete response (CR) rate at any time point of 75.5% (95% CI, 66.3-83.2%). The 12-month landmark CR rate was 46% (95% CI, 36.9-56.1). There are also 30 confirmed CRs that have reached the 24-month time point. Per Kaplan-Meier estimate, the 12- and 24-month CR rates are 50% (95% CI, 39.6-58.9%) and 41% (95% CI, 30.4-50.8%), respectively. The CR rate was consistent across patient subgroups.

Additionally, at 12 months, 97.3% of patients were free from progression to muscle-invasive bladder cancer, and the cystectomy-free survival was 90.0%.

Data also showed a sustained duration of response (DOR) in these patients. The estimated DOR was 63.7% (95% CI, 51.8-73.3%) at 12 months and 58.7% (95% CI, 46.4-69.0%) at 24 months. The median DOR has not been reached but exceeds 28 months (95% CI, 14.3-NE). The median follow-up is 22.3 months.

Bivalacqua noted during the presentation, “What this demonstrates very clearly is that patients that have a durable response at 12 months continue with a durable response at [24] months. We can hypothesize that this may relate to the innate to adaptive switching with immunogenic memory. However, this has never been proven.”

Cretostimogene was also generally well-tolerated, with the majority of adverse events (AEs) being grade 1 or 2. In total, 64.3% of patients experienced any grade treatment-related AE (TRAE). The most common TRAEs (reported in more than 10% of patients) included bladder spasms (25%), pollakiuria (20.5%), urgency (19.6%), dysuria (15.2%), and hematuria (13.4%). The median time to TRAE resolution was 1 day. There were no grade 3 or higher TRAEs, treatment-related discontinuations, or deaths.

Bivalacqua then outlined translational data on cretostimogene. Data collected in the induction period showed that levels of creto titer and GM-CSF in the urine both peaked following instillation and were sustained locally for 4 to 5 days. According to Bivalacqua, these data suggest that there is effective payload delivery.

In the maintenance phase, Bivalacqua noted, “We see similar pharmacokinetics with a peak and trough pattern as previously showed. And the titers are present throughout the maintenance period.”

Cretostimogene also demonstrates stable and robust antibody and anti-tumor response. Antibody response was shown to be associated with clinical outcomes.

There were no creto levels detected systemically, with concentration remaining in the bladder even with repeat dosing. Based on these findings, the investigators concluded that post-cretostimogene close contact precautions are not needed.

In total, cohort C of the BOND-003 study included 112 patients with high-risk BCG-unresponsive NMIBC with CIS. Patients enrolled in the study received an induction course of weekly cretostimogene for 6 weeks. For nonresponders, a second 6-week induction course was given. Patients then received a maintenance course of 3 weekly treatments every 12 weeks for year 1 and then every 6 months for years 2 and 3.

Bivalacqua noted, “Another important point to delineate between multiple trials in this disease space is the fact that this trial had mandatory biopsy at 12 months, which allows us to better detect the effectiveness of any therapeutic agent.”

Among those enrolled in the study, the majority of patients were male (74%), White (62%), and over 65 years of age (83%). This was also a heavily pretreated population; the median number of prior BCG instillations was 12 (range, 7 to 66).

The primary end point for the trial was CR rate at any time point. Secondary end points include CR at 12 months, DOR, recurrence-free survival, progression-free survival, cystectomy-free survival, and safety.

Cretostimogene currently has FDA breakthrough therapy and fast track designations for high-risk BCG-unresponsive NMIBC with CIS with or without papillary tumors.

 These designations were awarded in December 2023 based on initial findings from BOND-003.

“Cretostimogene’s strong safety and efficacy profile, combined with its best-in-class durability, address an unmet need for my non-muscle invasive bladder cancer patients,” concluded Bivalacqua, a professor of urology and oncology at the Perelman Center for Advanced Medicine at the University of Pennsylvania, in a news release on the findings.

 “Now with the new translational data indicating that post-treatment close contact precautions are unnecessary, I am confident that cretostimogene will represent a breakthrough in bladder cancer treatment, if approved by the FDA.”

1. Bivalacqua T, Tyson MD, Uchio EM, et al. Updated clinical & translational results: BOND-003 Cohort C- A phase 3, single-arm study of intravesical cretostimogene grenadenorepvec for high-risk BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. Presented at: 40

 Annual European Association of Urology Congress; March 21-24, 2025; Madrid, Spain. Abstract LB12.

2. Study of cretostimogene given in patients with non-muscle invasive bladder cancer, unresponsive to Bacillus-Calmette-Guerin (BOND-003). ClinicalTrials.gov. 

pdated January 6, 2025. Accessed March 25, 2025. https://clinicaltrials.gov/study/NCT04452591

3. CG Oncology receives both FDA fast track and breakthrough therapy designation for cretostimogene grenadenorepvec in high-risk BCG-unresponsive non-muscle invasive bladder cancer. News release. CG Oncology. December 5, 2023. Accessed March 25, 2025. https://cgoncology.com/cg-oncology-receives-both-fda-fast-track-and-breakthrough-therapy-designation-for-cretostimogene-grenadenorepvec-in-high-risk-bcg-unresponsive-non-muscle-invasive-bladder-cancer/

4. Cretostimogene grenadenorepvec data continues to demonstrate best-in-class durability of response as well as consistent and compelling safety and efficacy. News release. GC Oncology, Inc. March 24, 2025. Accessed March 25, 2025. https://ir.cgoncology.com/news-releases/news-release-details/cretostimogene-grenadenorepvec-data-continues-demonstrate-best

Updated data from the phase 3 BOND-003 trial underscore the efficacy, safety, and tolerability of cretostimogene grenadenorepvec in high-risk BCG-unresponsive NMIBC patients. The trial demonstrated a complete response rate of 75.5% at any time point, with a 12-month CR rate of 46% and a 24-month CR rate of 41%. The treatment was well-tolerated, with most adverse events being mild. Translational data indicated effective payload delivery and robust antibody responses. Cretostimogene has received FDA breakthrough therapy and fast track designations, highlighting its potential as a significant advancement in bladder cancer treatment.

"Now with the new translational data indicating that post-treatment close contact precautions are unnecessary, I am confident that cretostimogene will represent a breakthrough in bladder cancer treatment, if approved by the FDA," says Trinity J. Bivalacqua, MD, PhD. 

Cretostimogene grenadenorepvec continues to show favorable efficacy, safety in NMIBC

The addition of durvalumab (Imfinzi) to neoadjuvant chemotherapy did not affect the rate or timing of radical cystectomy and did not lead to an increased rate of surgical complications in patients with cisplatin-eligible muscle-invasive bladder cancer (MIBC), according to additional data from the phase 3 NIAGARA trial (NCT03732677).

The data were presented by James W.F. Catto, MBChB, PhD, FRCS, at the 40th Annual European Association of Urology (EAU) Congress in Madrid, Spain.

Initial data from the NIAGARA trial were shared at the 2024 European Society for Medical Oncology Congress in Barcelona, Spain and published in the

Overall, data showed that the addition of durvalumab to neoadjuvant chemotherapy prior to radical cystectomy significantly improved overall survival (24-month OS, 82.2% vs 75.2%; 

 = .0106) and event-free survival (24-month EFS, 67.8% vs 59.8%; 

< .0001) compared with neoadjuvant chemotherapy alone. The combination also led to a 10% improvement in pathological complete response rate (37.3% vs 27.5%; 

In the presentation at the EAU Congress, Catto began by stating, “It's an honor to be here talking about NIAGARA, which is the first prospective randomized trial to show an overall survival benefit in muscle-invasive bladder cancer with neoadjuvant treatment. We can't underestimate the importance of that.”

The current analyses focused on the impact that adding durvalumab had on surgical outcomes, as well as neoadjuvant safety data with the combination.

Overall, the addition of durvalumab did not appear to affect the rate of surgical completion. In the durvalumab plus chemotherapy arm, 469 patients (88%) underwent radical cystectomy compared with 441 patients (83%) in the chemotherapy alone arm.

Tumor characteristics were well balanced between both arms. In total, 60% of patients in both arms had higher than T2N0 disease.

Catto added, “[Overall,] 60% of people and 70% of people had a hysterectomy and an oophorectomy, but the new EAU guidelines are much more about organ-preserving approaches in women, so perhaps we'll see a pullback toward more organ preservation.”

The median time from the last dose of neoadjuvant chemotherapy to radical cystectomy was 5.6 weeks (range, 1.1-16.9 weeks) in the combination arm vs 5.4 weeks (range, 1.7-47.6 weeks) in the chemotherapy arm. In the durvalumab arm, 90% and 96% of patients had cystectomy within 56 days and 70 days following the last dose of neoadjuvant chemotherapy, respectively. In the chemotherapy alone arm, 90% and 95% of patients had undergone cystectomy within 56 and 70 days following the last dose of chemotherapy, respectively.

The proportion of patients with surgical complications was also comparable between both study arms. Approximately 16% of patients in each arm experienced a complication of grade 3 or higher.

Similarly, 93% of patients in each arm experienced a treatment-related adverse event (TRAE) during the neoadjuvant study period. TRAEs of grades 3 or 4 were reported in 38% of patients in the combination arm vs 41% of patients in the comparator arm.

The most common (10% or higher) AEs during the neoadjuvant study period included nausea (51% durvalumab/chemotherapy vs 46% chemotherapy), neutropenia (40% vs 45%), and fatigue (33% vs 30%).

Catto noted, “Neutropenia was the most concerning issue, but that's being driven by the chemotherapy.”

Additionally, immune-mediated AEs in the combination arm were generally low grade and consistent with previously reported safety data on durvalumab. These AEs were primarily driven by hypothyroid (3%) and hyperthyroid (2%) events. The median time to onset was 73 days (range, 29-141) for the hypothyroid events and 38 days (range, 22-112) for the hyperthyroid events.

In total, the NIAGARA trial enrolled 1063 patients with cisplatin-eligible MIBC. Patients were randomly assigned 1:1 to receive durvalumab plus chemotherapy (n = 533) or to chemotherapy alone (n = 530) followed by radical cystectomy. In the combination arm, patients also received 8 cycles of adjuvant durvalumab.

The primary end points for the study were event-free survival and pathological complete response. Overall survival was a key secondary end point. Safety end points include immune-mediated AEs.

Catto concluded during the presentation, “The addition of the durvalumab did not make treatment more morbid than chemotherapy alone, and it didn't change or increase the surgical complications you saw in the ward. It gives us a very safe signal for that approach for our patients. The immune-mediated adverse events aren’t new. They're rare, and apart from thyroid function, they're mostly happening before they come to a urologist. I think we can feel reassured by that.”

1. Catto JWF, Al-Ahmadie H, van der Heijden MS, et al. Surgical outcomes and neoadjuvant safety with perioperative durvalumab for muscle-invasive bladder cancer (NIAGARA). Presented at: 40

 Annual European Association of Urology Congress; March 21-24, 2025; Madrid, Spain. Abstract GC2.

2. Powles TB, van der Heijden MS, Galsky MD, et al. A randomized phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). Presented at: 2024 European Society for Medical Oncology Annual Congress; September 13-17, 2024; Barcelona, Spain. Abstract LBA5.

3. Powles T, Catto JWF, Galsky MD. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. 

. 2024;391(19):1773-1786. Accessed March 24, 2025. doi: 10.1056/NEJMoa2408154

The phase 3 NIAGARA trial evaluated the addition of durvalumab to neoadjuvant chemotherapy in patients with cisplatin-eligible muscle-invasive bladder cancer. Results showed that durvalumab did not affect the rate or timing of radical cystectomy or increase surgical complications. The combination improved overall survival and event-free survival compared to chemotherapy alone. Surgical outcomes and adverse events were comparable between both arms, with neutropenia being the most concerning issue. Immune-mediated adverse events were low grade and consistent with previous safety data on durvalumab.

“The addition of the durvalumab did not make treatment more morbid than chemotherapy alone, and it didn't change or increase the surgical complications you saw in the ward," says James W.F. Catto, MBChB, PhD, FRCS.

Additional NIAGARA data reinforce benefit of perioperative durvalumab in MIBC

A phase 1b/2a trial (NCT06596291) has been initiated to evaluate the safety, tolerability, and initial efficacy of the nonmultiplying gene therapy vector EG110A as a treatment for patients with neurogenic bladder-related incontinence following a spinal cord injury.

The first patient in the trial was dosed at Rancho Research Institute of Rancho Los Amigos National Rehabilitation Center in the greater Los Angeles area. The trial is taking place across 4 centers in the US, including the one in California, as well as in Michigan, Pennsylvania, and Texas.

According to EG 427, the developer of the therapy, “EG110A is a non-replicating HSV-1 vector that has been designed to selectively silence the signals of key bladder sensory neurons responsible for the bladder muscle overactivity, [while] preserving motor neuron and retaining normal bladder function.”

“They have modified the herpes virus, which affects nerves, so that it is not virulent and does not multiply, and are relying on its innate ability to travel along nerve cells and reside in the sensory cells by the spinal cord,” explained lead investigator of the Houston site Argyrios Stampas, MD, MS, in the news release.

 “Once the vector is in place, it will manufacture its medication. It will block the sensory signals in the spinal cord that cause reflexive bladder contractions. This is the science fiction stuff that I dreamed about as an undergrad.”

Compared with the current standard treatment for neurogenic bladder, which requires multiple injections every 6 months, EG110A was shown to last for several years in preclinical studies.

“When people living with spinal cord injury are surveyed, bowel and bladder issues are their top priority,” added Stampas, an associate professor of physical medicine and rehabilitation in McGovern Medical School at UTHealth Houston and director of Spinal Cord Injury Medicine Research at TIRR Memorial Hermann. “The opportunity to have one procedure that could relieve incontinence for years would be a huge improvement on their quality of life.”

In total, the 52-week dose-escalation study plans to enroll 16 adult patients with neurogenic bladder due to a spinal cord injury that occurred at least 12 months before study screening. To be eligible for enrollment, patients must be aged 18 to 75, have persistent urinary incontinence after standard of care therapy, and must perform clean intermittent catheterization on a regular basis.

According to EG 427, those enrolled in the study will receive “a single treatment course consisting of multiple intradetrusor injections of EG110A.” EG110A will be administered across 3 dose levels (low, medium, and high) to determine the recommended dose level for further assessment.

The primary outcome measure is the incidence of treatment-emergent adverse events. Secondary outcome measures include the change in urodynamic variable from baseline to weeks 12 and 52 as well as outcomes from a 7-day bladder diary, which will record urinary incontinence episodes, daily catheterization rates, and volume per catheterization.

The study also includes a 5-year safety follow-up period.

1. Significant milestone reached for EG 427 with first patient treated with EG110A, first non-replicative herpes vector based genetic medicine for the treatment of neurogenic bladder. News release. EG 427. February 27, 2025. Accessed March 14, 2025. https://eg427.com/First-Patient-EG110A.html

2. New clinical trial at UTHealth Houston tests gene therapy vector that delivers drug aimed at stopping overactive bladder in patients with spinal cord injury. News release. University of Texas Health Science Center at Houston. March 12, 2025. Accessed March 14, 2025. https://www.newswise.com/articles/new-clinical-trial-at-uthealth-houston-tests-gene-therapy-vector-that-delivers-drug-aimed-at-stopping-overactive-bladder-in-patients-with-spinal-cord-injury

3. Dose escalation study of EG110A, administered by intradetrusor injections to adults with neurogenic detrusor overactivity-related incontinence following spinal cord injury who regularly perform clean intermittent catheterization. ClinicalTrials.gov. Last updated February 11, 2025. Accessed March 14, 2025. https://clinicaltrials.gov/study/NCT06596291

A phase 1b/2a trial is underway to assess the safety, tolerability, and initial efficacy of EG110A, a non-replicating HSV-1 vector, for treating neurogenic bladder-related incontinence post-spinal cord injury. The trial, conducted across four US centers, involves a 52-week dose-escalation study with 16 adult participants. EG110A aims to silence bladder sensory neurons while preserving motor function, potentially offering long-lasting relief compared to current treatments. Primary outcomes focus on treatment-emergent adverse events, with secondary measures including urodynamic changes and bladder diary outcomes.

The 52-week study plans to enroll 16 patients across 4 sites in the US.

Carl Cadregari

Articles

Latest Updated Articles