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

According to the authors, these data support the value of PSMA PET/CT in the pre-salvage radiotherapy selection process. 

PSMA PET/CT prior to salvage radiotherapy may improve overall survival

First Assist: GU Oncology Unpacked, hosted by Taylor Goodstein, MD, is the latest multimedia program from Urology Times.



Introducing First Assist: GU Oncology Unpacked, with Taylor Goodstein, MD!

The ARCHER trial is seeking to determine whether ultra-hypofractionated radiotherapy is non-inferior to hypofractionated radiotherapy in terms of bladder-intact event-free survival.

ARCHER trial opens enrollment to assess shorter duration of radiation therapy for MIBC

The agent is currently being evaluated in a phase 1/2 trial.

FDA grants fast track designation to HLD-0915 in mCRPC

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Smigelski is a chief resident at NewYork-Presbyterian/Columbia University Irving Medical Center, New York, New York.

Growing evidence supports the existence of an intermediate metastatic disease state.

Management of hormone-naïve oligometastatic prostate cancer

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

 shed light on factors associated with recurrence following high-intensity focused ultrasound (HIFU) for prostate cancer.

 These data point to the importance of careful patient selection for HIFU, as the therapy was shown to be an effective and tolerable treatment option for patients with intermediate-risk localized prostate cancer.

"Focal therapies such as HIFU are an exciting and rapidly evolving option for localized prostate cancer, offering meaningful cancer control while preserving urinary and sexual function," said lead author Kevin Shee, MD PhD, a PGY6 resident at the University of California, San Francisco (UCSF), in correspondence with 

However, our findings highlight that HIFU is not a one-size-fits-all solution—its success depends on careful patient selection based on PSA, Gleason grade, and genomic risk. Tailoring treatment to the right patient is essential to achieving optimal outcomes."

For the study, the investigators conducted a retrospective review of 135 men who underwent a HIFU procedure at UCSF between 2021 to 2023. All patients had a 1-year post-HIFU MRI-fusion biopsy. The median age of patients at diagnosis was 66 years (IQR, 59 to 71).

According to biopsy data collected at a median of 12 months of follow-up, 54% of patients experience a recurrence of grade group 2 or higher disease, and 41% of patients had an in-field recurrence.

Multivariable logistic regression showed that overall recurrence was associated with GG3 or higher disease (HR, 2.62; 95% CI, 1.03 to 6.67) and a prostate-specific antigen (PSA) level of greater than 10 vs less than 6 ng/mL (HR, 5.64; 95% CI, 1.82 to 17.48). Further, in-field recurrence was associated with GG3 or higher disease (HR, 3.11; 95% CI, 1.30 to 7.47) and a high vs low/intermediate genomic risk score (HR, 2.87; 95% CI, 1.18 to 6.99).

The authors also added, “Notably, we found no significant differences in biopsy outcomes between cases treated early at our institution and later, showing no identifiable learning curve with the FocalOne device.”

Data also showed no association between the location of treatment and disease recurrence, in line with prior literature.

In total, 4 patients (3%) in the study underwent a repeat HIFU procedure. At 1 year, the rate of treatment failure, defined as progression to salvage-whole gland therapy or the development of metastasis, was 4%. The overall treatment failure rate was 16%, and the median time to treatment failure was 16 months (IQR, 13 to 18).

The investigators also compared SHIM and International Prostate Symptom Scores (IPSS) before and at 1 year following HIFU. Notably, they found no significant difference between pre- and post-HIFU SHIM scores or IPSSs. Specifically, the median SHIM score was 16 (IQR, 3 to 24) before HIFU and 13 (IQR, 3 to 21) following the procedure. The median IPSS was 6 (IQR, 3 to 12) before HIFU and 6 (IQR, 4 to 10) following the procedure.

There were also no reported instances of Clavien-Dindo greater than 2 complications or the development of rectal fistulae or urinary strictures following HIFU during the study duration.

According to the authors, these findings support the viability of HIFU in patients with intermediate risk localized prostate cancer. Significantly, they found no impact on urinary or sexual function at 1 year following treatment, which is a key advantage of focal therapy over whole-gland therapy, they explained.

However, the authors caution that a key limitation of the study is generalizability, as the data were collected from a single institution in a homogenous cohort.

They write, “Longer follow-up is needed to determine its impact on local progression and metastasis, highlighting the importance of patient selection, especially in those with a high genomic risk, high PSA, or GG3+ disease.”

1. Shee K, Pace WA, Liu AW, et al. Determining optimal patient selection for high-intensity focused ultrasound for prostate cancer. 

. 2025 Aug 2:S2405-4569(25)00174-9. doi:10.1016/j.euf.2025.06.007

High-intensity focused ultrasound (HIFU) is an effective treatment for intermediate-risk localized prostate cancer, but careful patient selection is crucial due to recurrence risks. A study of 135 men at UCSF showed a 54% recurrence rate of grade group 2 or higher disease. Recurrence was linked to higher-grade disease and elevated PSA levels. No significant differences in urinary or sexual function were observed post-treatment. The study highlights the importance of patient selection, especially for those with high genomic risk, high PSA, or GG3+ disease, and calls for longer follow-up.

HIFU was shown to be an effective and tolerable treatment option for patients with intermediate-risk localized prostate cancer. 

Study offers insights into optimal patient selection for HIFU in prostate cancer

Updated data from the phase 3 ENVISION trial (NCT05243550) point to sustained efficacy of mitomycin for intravesical solution (Zusduri; formerly UGN-102) in patients with recurrent low-grade, intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC). Specifically, treatment with mitomycin intravesical solution led to a 24-month duration of response (DOR) of 72.2% (95% CI, 64.1 to 78.8) among patients who achieved an initial complete response to treatment at 3-month follow-up, UroGen reported in a news release.

Mitomycin for intravesical solution was granted FDA approval in June 2025 for adult patients with recurrent LG-IR-NMIBC based on initial data from the ENVISION trial.

“This latest update from the pivotal ENVISION trial of ZUSDURI showed that, among patients who achieved a complete response at 3 months, the probability of remaining event-free 24 months after CR was 72.2%,” said principal investigator Sandip Prasad, MD, MPhil, director of genitourinary surgical oncology and vice chair of urology at Morristown Medical Center/Atlantic Health System, NJ, in the news release.

 “Among patients who achieved a complete response, the event rate over time has remained stable. This DOR result highlights the sustained efficacy of the therapy and reinforces its potential as a durable treatment option.”

The median follow-up time after a 3-month CR in the current analysis was 23.7 months. At the time of data report, the median DOR has not been reached.

The most common adverse events (AEs) in the trial included dysuria, increased potassium, increased creatinine, decreased hemoglobin, increased eosinophils, increased aspartate aminotransferase, increased alanine aminotransferase, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria. According to UroGen, AEs were generally mild to moderate in severity.

Serious AEs were reported in 12% of patients and included urinary retention (0.8%) and urethral stenosis (0.4%).

The ENVISION trial initially met its primary end point by demonstrating a 78% (95% CI, 72 to 83) complete response rate in patients with LG-IR-NMIBC at 3 months following the first instillation of the therapy.

 Overall, 79% of responders remained in CR at 12 months.

Data presented at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois,

 additionally showed an 18-month CR rate of 80.6% (95% CI, 74.0 to 85.7).

Overall, the single-arm, multinational ENVISION trial evaluated the safety and efficacy of mitomycin as a primary chemoablative therapy in patients with LG-IR-NMIBC. In total, the study enrolled 240 adult patients across 56 sites in the US and Europe.

Patients were eligible for enrollment in the trial if they had a negative voiding cytology for high-grade disease within 8 weeks before screening, adequate organ and bone marrow function, and an anticipated life expectancy of at least the duration of the trial.

 Those included in the study received 6 once-weekly intravesical instillations of mitomycin.

The primary end point for the study was the complete response rate at 3 months following the first instillation of the therapy. Secondary outcome measures included DOR, durable complete response rate, disease-free survival, and safety.

“For the first time, adult patients with recurrent LG-IR-NMIBC have an FDA-approved therapy,” Prasad added in the news release.

 “This marks a potentially transformative step forward in how we manage this chronic, highly recurrent, and disruptive cancer. ZUSDURI is a new, outpatient treatment option for patients that can help provide a clinically meaningful recurrence-free interval, which is compelling given the highly recurrent nature of LG-IR-NMIBC.”

The ENVISION trial is ongoing to assess the long-term safety and efficacy of mitomycin for intravesical solution as part of a post-marketing commitment with the FDA, UroGen previously reported.

1. UroGen announces 24-month duration of response of 72.2% from the pivotal phase 3 ENVISION trial of ZUSDURI, the first and only FDA-approved medicine for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. News release. UroGen Pharma, Ltd. August 5, 2025. Accessed August 5, 2025. https://investors.urogen.com/news-releases/news-release-details/urogen-announces-24-month-duration-response-722-pivotal-phase-3

2. FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. News release. US Food & Drug Administration. June 12, 2025. Accessed August 5, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle

3. U.S. FDA approves UroGen’s ZUSDURI (mitomycin) for intravesical solution as the first and only medication for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). News release. UroGen Pharma, Ltd. June 12, 2025. Accessed August 5, 2025. https://investors.urogen.com/news-releases/news-release-details/us-fda-approves-urogens-zusduritm-mitomycin-intravesical

4. Prasad SM, Mihaylov NV, Khuskivadze A, et al. Duration of response (DoR) following treatment with UGN-102 in patients with recurrent, low-grade, intermediate-risk, non-muscle invasive, bladder cancer: 18-month DoR data from the phase 3 ENVISION trial. 

. 2025;43 (suppl 16). https://doi.org/10.1200/JCO.2025.43.16_suppl.4598

5. A phase 3 single-arm study of UGN-102 for treatment of low grade intermediate risk non-muscle-invasive bladder cancer (ENVISION). ClinicalTrials.gov. Last updated November 4, 2024. Accessed August 5, 2025. https://clinicaltrials.gov/study/NCT05243550

Updated data from the phase 3 ENVISION trial demonstrate the sustained efficacy of mitomycin for intravesical solution (ZUSDURI) in patients with recurrent low-grade, intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC). The treatment achieved a 24-month duration of response (DOR) of 72.2% among patients with an initial complete response at 3 months. The trial also reported a 78% complete response rate at 3 months and an 80.6% rate at 18 months. Adverse events were generally mild to moderate, with serious events in 12% of patients.

Treatment with mitomycin for intravesical solution led to a 24-month DOR of 72.2% among patients who achieved an initial complete response. 

Updated ENVISION data show sustained efficacy of mitomycin intravesical solution for LG-IR-NMIBC

1:56-4:02 - Importance of trial design in therapy selection

4:02-8:09 - Benefits of cooperative trials and comparison of trial end points

8:09-12:10 - Applicability of trial inclusion criteria in daily practice

12:10-13:17 - Moving away from ADT monotherapy as a comparator and applicability of subset analysis

13:17-16:08 - Evaluating the relevance of a clinical trial

16:08-18:59 - Translating statistical significance, biomarker analysis, and subgroup analysis to the clinic

18:59-22:34 - Use of rPFS in informing clinical decisions

22:34-26:56 - Evaluation of patients with conventional imaging and PSMA PET

26:56-31:14 - Importance of quality of life data in clinical trials

31:14-34:34 - Importance of trial design in evaluating a therapy

34:34-37:22 - Patient selection for triplet therapy

Jack Andrews, MD; Alicia Morgans, MD, MPH; and Ashley Ross MD, PhD, discuss how trial design, inclusion criteria, and end points like radiographic progression-free survival vs overall survival impact clinical decision-making in prostate cancer treatment, emphasizing the importance of quality of life data and the shift from using ADT alone as standard care toward combination therapies in prostate cancer management.

Michael Smigelski, MD

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