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The CHAI biomarker was shown to outperform EAU and AUA stratifications. 

CHAI biomarkers demonstrate prognostic utility for high-grade Ta NMIBC

Neckonoff is a graduating student of osteopathic medicine at New York Institute of Technology College of Osteopathic Medicine in New York, New York.

Benjamin P. Saylor is associate editor of Urology Times, an Advanstar Communications publication.

"Osteopathic urologists were more likely to work in private practice (58.4% vs 49.8%; P = .038) and in rural/nonmetropolitan areas (16.2% vs 8.7%; P = .002)," write the authors. 

Is there a difference between MD and DO in urology?

The results from the SABRE trial are intended to support the design of a registrational trial of 64Cu-SAR-Bombesin. 

64Cu-SAR-Bombesin shows efficacy in detecting prostate cancer recurrence

Benjamin M. Brucker, MD, discusses best practices for the onabotulinumtoxinA procedure, spanning all phases of treatment—before, during, and after administration.

From prep to follow-up: Key considerations for administering onabotulinumtoxinA

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

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"Targeted counseling regarding sleep hygiene improvements may positively affect several urologic disorders while also facilitating a host of overall health benefits," write Hudson Pierce and Bilal Chughtai, MD.

Impact of poor sleep quality on urologic disease

The FDA has accepted a new drug application (NDA) for zoliflodacin, an investigational first-in-class, single-dose, spiropyrimidinetrione oral antibiotic for the treatment of adult and pediatric patients 12 years and older with uncomplicated gonorrhea, Innoviva Specialty Therapeutics announced in a news release.

The Prescription Drug User Fee Act (PDUFA) target action date for the application is December 15, 2025.

Zoliflodacin is an oral antibiotic that inhibits type II topoisomerase, a bacterial enzyme that plays a key role in bacterial function and reproduction. According to the company, “If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades.”

The FDA has also granted a Qualified Infectious Disease Product designation to zoliflodacin, which enables the agent to benefit from priority review and market exclusivity.

“Today’s acceptance of the zoliflodacin NDA marks significant progress toward delivering health care providers with a potential new oral treatment option for uncomplicated gonorrhea, including infections caused by drug-resistant strains,” said David Altarac, MD, Chief Medical Officer of Innoviva Specialty Therapeutics, in the news release.

 “We look forward to working closely with the FDA during its review and, if approved, we are committed to expediting the availability of zoliflodacin to patients in the U.S.”

The NDA for zoliflodacin is supported by data from several clinical trials conducted through a collaboration with the Global Antibiotic Research & Development Partnership (GARDP). This portfolio of studies includes a pivotal phase 3 trial (NCT03959527) that evaluated zoliflodacin vs a standard of care (SOC) regimen (500 mg ceftriaxone intramuscular plus 1g oral azithromycin) in patients with uncomplicated gonorrhea.

Overall, the trial met its primary end point by demonstrating that zoliflodacin was non-inferior to the SOC regimen regarding microbiological response at the urogenital site at the test of cure visit (6 +/- 2 days following treatment). Specifically, the microbiological cure rate was 90.9% in the zoliflodacin arm vs 96.2% in the ceftriaxone/azithromycin arm, representing a difference of 5.3% (95% CI, 1.4% to 8.7%) across patients in the micro-intent-to-treat (ITT) population.

The 2 cohorts also demonstrated comparable results on the trial’s secondary end point of microbiological response at extragenital (rectal or pharyngeal) sites. Specifically, at pharyngeal sites, the cure rate was 79.2% in the zoliflodacin arm vs 78.6% in the ceftriaxone/azithromycin arm (difference, -0.67%; 95% CI, -20.8 to 16.3). At rectal sites, the cure rate was 87.3% and 88.6%, respectively (difference, 1.23%; 95% CI, -14.4 to 12.6).

Zoliflodacin was generally well-tolerated in the trial. Treatment-emergent adverse events (TEAEs) occurred in 46.2% of patients in the zoliflodacin arm vs 46.4% of patients in the ceftriaxone/azithromycin arm. The most common TEAEs in the zoliflodacin arm included headache (9.9%), neutropenia (6.8%), and leukopenia (3.9%).

There were no deaths or serious adverse events reported in either arm.

In total, the phase 3 trial included 930 patients with uncomplicated gonorrhea, including patients living with HIV. The study enrolled participants across 16 clinical trial sites in the US, Belgium, the Netherlands, South Africa, and Thailand.

According to Innoviva, the phase 3 study was “the largest clinical trial ever conducted for a new treatment against gonorrhea infection.”

Those enrolled in the study were randomly assigned 2:1 to receive 3 g single-dose, oral zoliflodacin (n = 621) or to 500 mg ceftriaxone intramuscular plus 1g oral azithromycin (n = 309). The primary end point was microbiological cure by culture at urogenital sites in the micro-ITT populations, with a non-inferiority margin of 12%. The trial’s secondary end point was microbiological cure at extragenital sites.

“This important milestone demonstrates the crucial role that public-private partnerships can play in tackling the escalating global antimicrobial resistance crisis,” said Manica Balasegaram, Executive Director of GARDP, in the news release.

 “If zoliflodacin is approved, this collaboration paves the way for millions of people across the world to get access to a potentially powerful new drug to treat multidrug-resistant gonorrhea.”

1. Innoviva Specialty Therapeutics receives FDA New Drug Application acceptance for zoliflodacin, a first-in-class oral antibiotic for uncomplicated gonorrhea in adults. News release. Innoviva Specialty Therapeutics. Published online and accessed June 10, 2025. https://innovivaspecialtytherapeutics.com/innoviva-specialty-therapeutics-receives-fda-new-drug-application-acceptance-for-zoliflodacin-a-first-in-class-oral-antibiotic-for-uncomplicated-gonorrhea-in-adults/

2. FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025. News release. Innovia Specialty Therapeutics, Inc. Published online and accessed June 12, 2025. https://www.businesswire.com/news/home/20250612432209/en/FDA-Grants-Priority-Review-for-Zoliflodacin-New-Drug-Application-for-the-Treatment-of-Uncomplicated-Gonorrhea-and-Assigns-Target-PDUFA-Date-of-December-15-2025 

3. Luckey A, Broadhurst H, Daram P, et al. Oral zoliflodacin is non-inferior to a combination of ceftriaxone and azithromycin for treatment of uncomplicated urogenital gonorrhoea: results of a large global Phase 3 randomised controlled trial. Presented at: European Society of Clinical Microbiology and Infectious Disease Global Congress. April 27-30, 2024. Barcelona, Spain. https://gardp.org/wp-content/uploads/2024/04/Zoli001-Topline-ECCMID2024_final_V1.0_23Apr2024_.pdf

The FDA has accepted the NDA for zoliflodacin, a novel oral antibiotic for treating uncomplicated gonorrhea in patients aged 12 and older. Zoliflodacin, which inhibits type II topoisomerase, has been granted a Qualified Infectious Disease Product designation, allowing for priority review. Clinical trials, including a pivotal phase 3 study, demonstrated that zoliflodacin is non-inferior to the standard regimen of ceftriaxone and azithromycin. The trials showed comparable microbiological cure rates at urogenital and extragenital sites, with zoliflodacin being generally well-tolerated and no serious adverse events reported.

The NDA is supported by a pivotal phase 3 trial of zoliflodacin vs ceftriaxone plus azithromycin in patients with uncomplicated gonorrhea. 

News

FDA accepts new drug application for zoliflodacin for uncomplicated gonorrhea

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

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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. 

FDA accepts BLA for subcutaneous nivolumab in solid tumors

 (Jun. 2, 2025) — The University of Miami Board of Trustees has unanimously selected 

 as the next Chief Executive Officer of UHealth, as well as Executive Vice President for Health Affairs at the University of Miami, effective immediately. Dr. Parekh, a globally renowned urologic oncologist, healthcare innovator, and leader in academic medicine has served as the Chief Operating Officer of the University of Miami Health System since 2020, and alongside University of Miami President Joseph J. Echevarria jointly engineered UHealth’s dramatic turnaround over the last five years.

“Dipen has played a pivotal role each step of the way as the University of Miami Health System has grown into one of the top academic medical centers in the country,” noted President Echevarria. “He understands the mission—from the operating room to the classroom to the boardroom—and he embodies the excellence we strive to deliver for our patients, students, and community.”

“As Joe ascended to become President of the University of Miami a year ago, Dipen’s talent, experience, academic pedigree, and work ethic made him the right choice to become CEO of the health system,” Stuart Miller, Chair of the UHealth Board of Directors explained to his fellow University of Miami Trustees at the Annual Meeting of its Board on May 30. “While Joe will continue to be the President of both the University and UHealth, Dipen will leverage his considerable skills and credibility as a surgeon, clinical leader, and NCI-funded scientist with over 200 peer reviewed publications, to lead the stellar faculty and clinicians at South Florida’s only academic health system, and to enhance our critical community partnership with Jackson Health System.”

While serving as Chief Operating Officer of UHealth, in 2021 Dr. Parekh was named Executive Dean for Clinical Affairs at the Miller School of Medicine, where he has worked to build synergy between the academic and clinical missions at the University of Miami. He is laser-focused on ensuring UHealth becomes a leader in developing and deploying emerging and effective treatments to improve wellbeing in Miami and beyond. His success has been nationally recognized, with Becker’s Hospital Review naming him among the top 60 academic health system COOs to know in 2024.

Having joined the institution in 2012 as Chair of the Department of Urology, Dr. Parekh’s first system-wide administrative role was as Chief Clinical Officer from 2017-2020. He is also an endowed professor of urology and the founding director of the Desai Sethi Urology Institute.

As a global leader in academic medicine, Dr. Parekh led a groundbreaking trial, published in 

 in 2018, which established the efficacy of robotic-assisted surgery for bladder cancer. He is a member of the Academy of Science, Engineering, and Medicine of Florida (ASEMFL), the American Association of Genitourinary Surgeons, and the Clinical Society of Genitourinary Surgeons.

Over the course of his career, Dr. Parekh has performed more than 6,000 robotic urologic cancer surgeries, making him one of the most experienced practitioners worldwide. As he has throughout his tenure at the University of Miami, Dr. Parekh will continue to treat patients.

“Dipen has excelled not only in managing day-to-day operations at UHealth, but in setting forward-looking strategy and embracing continuous improvement as our talented clinicians and faculty navigate an increasingly dynamic environment,” added University of Miami Board Chair Manny Kadre. “Dr. Parekh and President Echevarria are a proven, winning combination for our health system and community, who have the Board’s full support.”

“I am profoundly grateful for the trust placed in me and energized by the opportunity to advance our shared mission of delivering world-class care, pioneering research, and transformative education,” said Dr. Parekh in accepting the appointment. “I look forward to working with our exceptional faculty, staff, and our key partner, the Jackson Health System, to lead us into this next chapter, one grounded in collaboration, compassion, and a bold vision for the future of academic medicine.”

Award-winning COO of UHealth, renowned surgeon scientist, and director of the Desai Sethi Urology Institute elevated to lead patient-focused care, biomedical research, and medical education

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Dipen Parekh, M.D. named Chief Executive Officer of the  University of Miami Health System

 hosted a Clinical Forum program in Lone Tree, Colorado. At the event, urologists examined the shifting landscape of non–muscle-invasive bladder cancer (NMIBC) management, focusing on the integration of novel immunotherapies, the impact of BCG shortages, and the evolving roles of urologists and medical oncologists. As new agents like sasanlimab and gene therapies such as nadofaragene firadenovec-vcng (Adstiladrin) gain traction, participants emphasized the need for updated clinical pathways, enhanced training, and a collaborative approach to optimize outcomes. 

 a urologic oncologist with Colorado Urology in Lone Tree, served as moderator for the discussion. What follows is a summary of this discussion.

This summary was generated by artificial intelligence and edited by humans for clarity.

This Clinical Forum centered on the evolving landscape of NMIBC management, emphasizing current challenges, new therapies, and the coordination required between urologists and medical oncologists. The participants explored various aspects of diagnosis, treatment decision-making, and the integration of immunotherapies, highlighting the complexities many practices face as they adapt to emerging modalities.

The dialogue began with an overview of the current state of NMIBC treatment, noting the reliance on established intravesical therapies like BCG. Participants acknowledged the standard approach involves performing a transurethral resection of the bladder tumor (TURBT), followed by intravesical therapy, with immediate considerations for subsequent treatments based on patient response and tumor pathology. The discussion revealed that practices vary significantly, with some urologists preferring to proceed with TURBT and delaying cystoscopy or biopsy until a later date, especially in cases where the patient is anxious or tumor characteristics suggest the need for further evaluation.

A major challenge addressed in the Clinical Forum was managing BCG shortages and the implications for patient care. Several speakers pointed out that BCG remains a cornerstone of therapy, but supply issues force clinicians to reconsider treatment plans, leading to increased interest in alternative treatments and clinical trials. The conversation highlighted that practices are examining when and how to switch to other options like chemotherapy, device-based treatments, or early enrollment in clinical trials utilizing novel immunotherapies. The importance of personalized risk stratification was emphasized, with guidelines such as National Comprehensive Cancer Network (NCCN), European Association of Urology, and the American Urological Association being referenced as tools to aid decision-making. Participants generally favored the NCCN guidelines for their clarity and ease of use in clinical practice.

The role of urologists vs medical oncologists in administering immunotherapy treatments emerged as a significant theme. There is an ongoing discussion about whether urologists should take expanded responsibility for delivering immunotherapies, especially subcutaneous (sub-Q) or intravesical treatments, or whether such procedures should remain under the purview of medical oncologists. Some participants expressed confidence in urologists managing certain immunotherapies, citing the increasing familiarity with these agents and the potential for integrating them directly into urology clinics. Others highlighted concerns about the complexities pertaining to adverse event (AE) management, emphasizing that appropriate training and collaboration are essential.

Within this context, specific treatments such as sasanlimab were discussed. Sasanlimab, a PD-1 inhibitor, was referenced in relation to clinical trial data comparing its efficacy with BCG. The data indicate that sasanlimab, when combined with BCG induction and maintenance, can significantly reduce recurrence rates of high-grade tumors, with a more than 50% decrease in recurrence in some studies. However, the benefit appears to be more pronounced when combined with maintenance therapy, underscoring the importance of adherence to treatment protocols. The participants noted that although sasanlimab shows promise, more data are needed to fully understand its role in clinical practice, and the decision to incorporate it depends on ongoing research outcomes.

Training and competency development were also major focal points, particularly as newer therapies become more commonplace. The participants discussed the current gap in resident education regarding immunotherapies, especially given the rapid introduction of these agents into practice. There was concern that with overlapping roles and a blurry boundary between specialties, residents may not be receiving adequate training for managing complex treatments such as systemic immunotherapies or intravesical agents beyond BCG. The need for clearly defined roles and collaborative care pathways emerged as crucial to ensure safe and effective treatment delivery.

Another aspect of the discussion addresses the role of new FDA-approved therapies such as nadofaragene firadenovec-vncg, a gene therapy for bladder cancer that received approval in 2022, with availability only materializing in 2024 due to supply chain issues. The participants noted that these emerging treatments will add further options for bladder-sparing approaches, expanding the therapeutic landscape beyond traditional intravesical agents. The practical considerations of implementing these therapies, such as infrastructure requirements and the need for infusion capabilities, were acknowledged as potential barriers for some practices.

The participants also considered the future landscape of urologic training, emphasizing that as new therapies become more integrated into clinical practice, training programs will have to adapt. There was general consensus that practices will need to develop protocols for incorporating immunotherapies, including patient selection criteria, treatment pathways, and AE management. The importance of interdisciplinary collaboration was reiterated, with suggestions that coordinated efforts between urology and oncology will be necessary to optimize patient outcomes.

In conclusion, the Clinical Forum underscored the ongoing transition in NMIBC management driven by the introduction of immunotherapies and novel agents such as sasanlimab. Although traditional treatments like BCG continue to form the backbone of therapy, supply issues, evolving guidelines, and the availability of new drugs are prompting a reassessment of clinical pathways. Careful patient selection, enhanced training, and collaborative care models will be vital for integrating these therapies effectively. The discussion reflected a recognition that the landscape is rapidly changing, and practices must remain adaptable to incorporate new evidence and improve patient care outcomes.

The Clinical Forum in Lone Tree, Colorado, focused on the evolving management of non–muscle-invasive bladder cancer (NMIBC), highlighting challenges such as BCG shortages and the integration of novel immunotherapies like sasanlimab and gene therapies. The discussion emphasized the need for updated clinical pathways, enhanced training, and collaboration between urologists and medical oncologists. Participants explored the roles of these specialists in administering treatments and the importance of personalized risk stratification. The forum underscored the necessity for adaptable practices to incorporate new evidence and improve patient outcomes.

A major challenge addressed in the Clinical Forum was managing BCG shortages and the implications for patient care.

Urologists discuss managing NMIBC amidst BCG shortages

The first patient has been dosed in a phase 2 trial (NCT06971614) investigating MVR-T3011, an oncolytic immunotherapy for patients with BCG-unresponsive high-risk non–muscle invasive bladder cancer (NMIBC), ImmVira announced in a news release.

According to the company, MVR-T3011 is “a novel oncolytic immunotherapy combining a proprietary replication competent oncolytic virus backbone with payload expression of PD-1 Ab and IL-12.”

"MVR-T3011 represents a novel drug design and has the potential to address an unmet need in NMIBC,” said Vignesh T. Packiam, MD, principal investigator and the director of clinical and translational research in urologic oncology at Rutgers Cancer Center in New Jersey, in the news release.

 “Integration of PD-1 Ab and IL-12 genes into the genome of this novel oncolytic immunotherapy can augment immune responses in the tumor microenvironment and prolong the early-phase antitumor efficacy.”

In total, the single-arm, open-label trial plans to enroll 70 patients through 15 to 20 clinical trial sites across the US and China.

 Patients are eligible for enrollment if they have adequate laboratory test values, and ECOG Performance Status of 0 to 2, and an expected survival of at least 24 weeks.

In the study, MVR-T3011 will first be dosed at a level of 2×10

 PFU. If there are no safety concerns following the dose-limiting toxicity assessment, the investigators will then assess outcomes at the 1×10

Treatment will include both an induction and a maintenance period. In the induction period, patients will receive MVR-T3011 once a week for 6 weeks, followed by 6 weeks of observation and an efficacy assessment at 3 months. In the maintenance period, patients will receive MVR-T3011 every 3 weeks until approximately 24 months or until they meet the criteria for treatment discontinuation.

The objectives of the trial are to further confirm the recommended phase 2 dose and to assess the efficacy of MVR-T3011. The primary end points for the trial are complete response rate in patients with carcinoma in situ (CIS), recurrence-free survival in patients with high-grade Ta/T1 without CIS, and the incidence of dose-limiting toxicities across 2 dose levels. Secondary end points include longer-term (18 to 24 months) efficacy assessments and safety.

Primary completion of the trial is expected for December 2028.

"The initiation of this multi-country phase 2 study marks a major milestone for ImmVira," said Grace Guoying Zhou, PhD, co-founder, CEO, and chairwoman of ImmVira, in the news release.

 "We are delighted with the notable progress and results achieved in the phase I clinical trial of MVR-T3011 for the treatment of NMIBC and are extremely excited about working with key thought leaders in the U.S. and China to further explore the potential of this drug in NMIBC patients."

Data from a phase 1 study of MVR-T3011 were shared at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain.

At a data cutoff of June 2024, 14 patients were evaluable for efficacy. Among those, the 3-month complete response (CR) rate across all dose levels was 71.4% (10 of 14). At the 2×10

 PFU dose level, the CR rate was 87.5% (7 of 8). There were no dose-limiting toxicities reported, and a maximum tolerated dose had not been reached.

Updated findings with a data cutoff of September 2024 were also shared by ImmVira, which included data from 20 patients in the study.

 PFU, the 3-month CR rate was consistent at 81.8% (9 of 11).

Based on these results, the authors concluded, “Intravesical T3011 demonstrates promising anti-tumor efficacy and an excellent safety profile in patients with high-risk BCG-failure NMIBC.”

1. ImmVira announces first patient dosed in a multi-regional phase II clinical trial evaluating MVR-T3011 oncolytic immunotherapy in patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC). News release. ImmVira. Published online and accessed June 10, 2025. https://www.prnewswire.com/news-releases/immvira-announces-first-patient-dosed-in-a-multi-regional-phase-ii-clinical-trial-evaluating-mvr-t3011-oncolytic-immunotherapy-in-patients-with-bcg-unresponsive-high-risk-non-muscle-invasive-bladder-cancer-nmibc-302477586.html

2. A study of T3011 in patients with BCG-unresponsive high risk NMIBC. ClinicalTrials.gov. Last updated May 14, 2025. Accessed June 10, 2025. https://clinicaltrials.gov/study/NCT06971614

3. Ye D, Wu J, Zhou G, et al. Preliminary results from a phase I study of T3011, an oncolytic HSV expressing IL-12 and anti-PD-1 antibody, for BCG-failure non-muscle-invasive bladder cancer (NMIBC). 

. 2024;35 (suppl 2, S1156). https://www.annalsofoncology.org/article/S0923-7534(24)03603-2/fulltext

4. ESMO 2024 - ImmVira unveils clinical results of intravesical MVR-T3011 for high-risk BCG-failure NMIBC patients. News release. ImmVira. September 15, 2024. Accessed June 10, 2025. https://www.immviragroup.com/news/561.html

A phase 2 trial has commenced for MVR-T3011, an oncolytic immunotherapy targeting BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC). MVR-T3011 combines a replication-competent oncolytic virus with PD-1 Ab and IL-12 to enhance immune responses. The trial aims to enroll 70 patients across the US and China, assessing efficacy and safety at two dose levels. Phase 1 results showed promising efficacy and safety, with a 3-month complete response rate of 71.4% and no dose-limiting toxicities. Primary completion is anticipated by December 2028.

The objectives of the trial are to further confirm the recommended phase 2 dose and to assess the efficacy of MVR-T3011. 

Hudson Pierce

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