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

Gozellix was approved by the FDA in March 2025.

PSMA-PET imaging product, Gozellix, launches on US market

However, this regimen was associated with substantial toxicity, so careful patient selection is paramount, according to the authors.

Adding cetrelimab to niraparib maintenance shows benefit in aggressive variant prostate cancer

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

Phase 2 trial of oncolytic immunotherapy launches in BCG-unresponsive NMIBC

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

FDA accepts new drug application for zoliflodacin for uncomplicated gonorrhea

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Treatments provide a targeted therapeutic strategy for metastatic
castration-resistant prostate cancer. 

PARP inhibitors: Treating mCRPC from a genetic basis 

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

The first patient has been dosed in a phase 1 trial (NCT06801236) investigating the novel CYP11A1 inhibitor ACE-232 in patients with metastatic castration-resistant prostate cancer (mCRPC), Acerand Therapeutics announced in a news release.

According to the company, ACE-232 is a “highly potent and selective small-molecule inhibitor of CYP11A1, a key adrenal enzyme involved in the first and rate-limiting step of steroid hormone biosynthesis.”

In preclinical studies, ACE-232 demonstrated superior potency, efficacy, and pharmacokinetic properties compared with other CYP11A1 inhibitors. The data, which were presented at the 2025 American Association for Cancer Research Annual Meeting in Chicago, Illinois, also showed that ACE-232 was well-tolerated and demonstrated efficacy against preclinical models resistant to current therapies, including abiraterone acetate (Zytiga) and enzalutamide (Xtandi), Acerand reported.

The FDA granted an investigational new drug clearance to the agent in January 2025 to initiate the first-in-human trial.

“I would like to congratulate the Acerand team, the research staff, and the first patient for helping us to reach this important milestone,” said principal investigator Emmanuel S. Antonarakis, MD, in the news release.

 Antonarakis is the director of genitourinary oncology at the Masonic Cancer Center at the University of Minnesota, Minneapolis.

In total, the open-label phase 1 trial plans to enroll 67 adult patients across clinical trial sites in the US and Canada.

Patients are eligible for enrollment if they have mCRPC with ongoing androgen deprivation therapy or have bilateral orchiectomy, an ECOG Performance Status of 0 or 1, a life expectancy of at least 6 months, and adequate organ and bone marrow function. Patients must have also underwent at least 1 prior line of therapy with a novel hormonal agent and taxane-based chemotherapy in the castration-resistant or hormone-sensitive setting.

The study is being conducted in 2 parts: a dose escalation and dose optimization phase. In phase 1, the investigators will assess the safety, tolerability, pharmacokinetic profile, and pharmacodynamics in patients following treatment with ACE-232. Phase 1 also seeks to establish a maximum tolerated dose, if applicable. In phase 2, patients with androgen receptor gene alterations will receive ACE-232 at 2 different dose levels with the goal of establishing the recommended phase 2 dose.

For the study, patients will receive ACE-232 tablets orally as a continuous regimen with dexamethasone and fludrocortisone (Florinef) until disease progression, unacceptable toxicity, or study withdrawal.

The primary end points for the study are the number of patients experiencing an adverse event (AE) or serious AE, the number of patients experiencing a dose-limiting toxicity, and the establishment of a maximum tolerated dose and recommended phase 2 dose. Secondary outcome measures include pharmacokinetic measures, prostate-specific antigen response, objective response rate, duration of response, radiographic progression-free survival, overall survival, and blood concentration of steroid hormone.

The investigators are also seeking to assess the association between gene aberrations in circulating tumor DNA and tumor response to treatment as an exploratory end point.

Final completion of the trial is expected in August 2028.

1. Acerand Therapeutics initiates first-in-human phase I clinical trial of ACE-232, a novel CYP11A1 inhibitor for advanced prostate cancer. News release. Acerand Therapeutics. June 4, 2025. Accessed June 9, 2025. https://www.acerand.com/nw_20250604.html

2. Acerand announces promising ACE-232 preclinical data to be presented at the 2025 AACR Meeting. News release. Acerand Therapeutics. April 10, 2025. Accessed June 9, 2025. https://www.acerand.com/nw_20250410.html

3. Phase 1 study of ACE-232 to treat patients with metastatic castration-resistant prostate cancer. ClinicalTrials.gov. Last updated May 18, 2025. Accessed June 9, 2025. https://clinicaltrials.gov/study/NCT06801236

A phase 1 trial has commenced for ACE-232, a novel CYP11A1 inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC). ACE-232 has shown superior potency and efficacy in preclinical studies, particularly against models resistant to current therapies. The trial, involving 67 patients across the US and Canada, will assess safety, tolerability, and pharmacokinetics, aiming to establish a maximum tolerated dose. The study will also explore the relationship between gene aberrations in circulating tumor DNA and treatment response, with completion expected by August 2028.

In preclinical studies, ACE-232 demonstrated superior potency, efficacy, and pharmacokinetic properties compared with other CYP11A1 inhibitors. 

Phase 1 study launches for novel CYP11A1 inhibitor for mCRPC

Radical cystectomy should continue to have an important role in the management of patients with recurrent high-grade non–muscle invasive bladder cancer (NMIBC), according to 12-month results from the CISTO study (NCT03933826).

2025 American Urological Association (AUA) Annual Meeting

 in Las Vegas, Nevada by John L. Gore, MD, MS, an adjunct professor of surgery at the Fred Hutchinson Cancer Center at the University of Washington in Seattle.

“We previously demonstrated in a broad survey of over 1000 patients in the Bladder Cancer Advocacy Network Patient Survey Network that the highest priority for patients with non–muscle invasive bladder cancer is to better understand how to make decisions about the timing of radical cystectomy as well as how to balance that with other treatments when their bladder cancers fail BCG,” Gore explained during the presentation. “We demonstrated in a comprehensive systematic review that limited evidence is available to help clinicians make better decisions for their patients with recurrent high-grade non–muscle invasive bladder cancer.”

To that end, the investigators launched the CISTO study to assess outcomes with intravesical therapy vs radical cystectomy in this patient population. The trial was conducted as a prospective observational cohort study.

“Our engagement with patients in the Bladder Cancer Advocacy Network informed the CISTO study design, as patient responses told us that a randomized control trial would not be feasible, given that only 11% of patients would be willing to be randomized in a comparison of radical cystectomy—a morbid, large-scale surgery—with bladder-sparing treatments.”

In total, the trial included 371 patients in the bladder-sparing therapy arm and 199 patients in the surgery arm.

Gore noted, “Our treatment groups were balanced by sex, race and ethnicity, and comorbidity burden. Patients undergoing radical cystectomy were younger, were more likely to be partnered, were less likely to live in an urban area, and had higher cancer severity as measured by a greater proportion of patients with T1 disease or concomitant CIS.”

On the study’s primary end point of 12-month physical functioning, the data showed no significant difference between the study cohorts.

Gore added, “[In] data within subgroups of patients with concomitant CIS and among individuals who were not partnered at enrollment, physical functioning was better in the radical cystectomy arm.”

Patients in the radical cystectomy arm also demonstrated improved global health compared with those in the bladder-sparing therapy arm. Additionally, patients in the radical cystectomy arm showed favorable emotional functioning scores vs those in the bladder-sparing therapy arm, which included lower levels of depression and anxiety.

Scores for financial difficulties and financial toxicity also favored the radical cystectomy arm.

Longitudinal physical functioning scores were largely comparable between both cohorts.

Gore reported, “[Our data showed] similar physical functioning at enrollment, an expected decline in physical functioning at 3 months after radical cystectomy given the large scale of the surgery, but a recovery trajectory where physical functioning is similar between treatment groups by 6 months. This was true across the entire cohort, as well as among those patients over 75 years of age, demonstrating that the finding of noninferior physical functioning held true for older CISTO study participants as well.”

However, patients who underwent radical cystectomy demonstrated worse urinary health scores compared with those who received bladder-sparing therapy. Both sexual quality of life and bowel quality of life scores were also worse among patients who underwent radical cystectomy.

Regarding clinical outcomes, data showed comparable bladder cancer-specific survival rates between the 2 arms. Specifically, the rate was 96% in the radical cystectomy arm vs 99% in the bladder-sparing therapy arm (aRR, 0.98; 95% CI, 0.96 to 1.01). However, the radical cystectomy cohort demonstrated a significant improvement in 12-month recurrence-free survival (RFS). In the radical cystectomy arm, RFS was 96%, compared with 67% in the bladder-sparing therapy arm (aRR, 0.12; 95% CI, 0.06 to 0.27).

Gore also added, “Twelve-month progression-free survival was significantly better in the bladder-sparing therapy arm, although this was mostly driven by pathologic upstaging for patients in the radical cystectomy arm.”

The CISTO study remains ongoing to assess longer-term outcomes.

“Radical cystectomy, as demonstrated by the CISTO study, has and should continue to have an important role in the management of recurrent high-grade non–muscle invasive bladder cancer,” Gore concluded during the presentation. “These are outcomes that do inform patient and clinician decision-making, and we have obtained additional NCI [National Cancer Institute] funding that will support ascertaining longer-term patient-reported and clinical outcomes.”

1. Gore JL, Wolff EM, Nash MG, et al. Radical cystectomy versus bladder-sparing therapy for recurrent high-grade non-muscle invasive bladder cancer: Results from the comparison of intravesical therapy and surgery as treatment options (CISTO) study. 

2025;213(5S):e3. doi:10.1097/01.JU.0001111604.90306.91.05

The CISTO study highlights the significant role of radical cystectomy in managing recurrent high-grade non–muscle invasive bladder cancer (NMIBC). Conducted as a prospective observational cohort study, it compared outcomes of radical cystectomy with bladder-sparing therapy. Results showed no significant difference in 12-month physical functioning between the groups, but radical cystectomy patients had better global health and emotional functioning. However, they experienced worse urinary, sexual, and bowel quality of life. Radical cystectomy showed improved recurrence-free survival, while bladder-sparing therapy had better progression-free survival. The study continues to assess long-term outcomes.

Twelve-month physical functioning scores were comparable between the radical cystectomy arm and the bladder-sparing therapy arm.

CISTO: Radical cystectomy has key role in recurrent high-grade NMIBC

 (Nubeqa) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).

The approval was supported by data from the phase 3 ARANOTE trial (NCT04736199), which showed that darolutamide plus ADT significantly extended radiographic progression-free survival (rPFS) compared with placebo plus ADT in patients with mCSPC.

 At 24 months, the rate of rPFS was 70.3% in the darolutamide arm vs 52.1% in the placebo arm, translating to a 46% reduction in the risk of radiographic progression or death (HR, 0.54; 95% CI, 0.41-0.71; 

Darolutamide was previously approved in the US for mCSPC in combination with docetaxel.

, lead author of the ARANOTE trial, shares his thoughts on the recent approval of darolutamide in mCSPC and walks through key data that supported the agency’s decision. Saad is a professor and chairman of the department of surgery as well as the head of GU oncology at the University of Montreal.

Fred Saad, MD, FRCS, lead author of the ARANOTE trial, shares his thoughts on the recent approval of darolutamide and walks through key data supported the agency’s decision.

Fred Saad, MD, FRCS, reacts to FDA approval of darolutamide in mCSPC

In total, the ARANOTE trial included 669 patients who were randomly assigned 2:1 to receive 600 mg darolutamide twice daily plus ADT (n = 446) or to matching placebo plus ADT (n = 223).

In a final analysis of the data, there was no statistically significant improvement in overall survival (OS) with the addition of darolutamide (HR, 0.78; 95% CI, 0.58 to 1.05). At 24 months, the OS rate was 79.8% in the darolutamide arm and 75.5% in the placebo arm.

Data did show improvements in the trial's key secondary end points with the addition of darolutamide.Specifically, darolutamide was associated with a trend toward clinical benefit in the time to metastatic castration-resistant prostate cancer (HR, 0.40; 95% CI, 0.32 to 0.51) and time to prostate-specific antigen PSA progression (HR, 0.31; 95% CI, 0.23 to 0.41). Time to pain progression (HR, 0.72; 95% CI, 0.54 to 0.96), and time to subsequent systemic anticancer therapy (HR, 0.40; 95% CI, 0.29 to 0.56) were also delayed in the darolutamide arm.

Treatment was well-tolerated across both study arms. The incidence of treatment-emergent adverse events (TEAEs) was similar between the 2 groups, with TEAEs leading to permanent discontinuation of study drug occurring in 6.1% of patients in the darolutamide/ADT arm and 9.0% of patients in the placebo/ADT arm. No new safety signals were reported.

Based on these data, Saad concluded, “[It was] very reassuring that the adverse event profile was basically identical to placebo, including fatigue, which is one of the most common complaints, was not greater than the placebo. If anything [it] looked like slightly less fatigue with darolutamide than with placebo, so very reassuring in terms of efficacy and in terms of tolerability and adverse events.”

1. FDA approves darolutamide for metastatic castration-sensitive prostate cancer. News release. US Food & Drug Administration. June 3, 2025. Accessed June 5, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer

2. Saad F, Vjaters E, Shore N, et al. Darolutamide in combination with androgen-deprivation therapy in patients with metastatic hormone-sensitive prostate cancer from the phase III ARANOTE trial. 

. 2024 Sep 16:JCO2401798. doi:10.1200/JCO-24-01798

The approval of darolutamide in mCSPC was supported by data from the phase 3 ARANOTE trial. 

The FDA has authorized an Expanded Access Program (NCT06956547) for use of nogapendekin alfa inbakicept-pmln (NAI; Anktiva) to manage lymphopenia in adult patients with refractory or relapsed solid tumors, including genitourinary tumors, who have progressed after first-line standard-of-care treatment with chemotherapy, radiation, and/or checkpoint inhibitors, ImmunityBio announced in a news release.

The Expanded Access Program is specifically assessing the use of ImmunityBio’s Cancer BioShield platform, which includes NAI at its core. NAI was approved by the FDA in 2024 for the treatment of patients with BCG-unresponsive non–muscle invasive 

 (NMIBC) with carcinoma in situ (CIS) with or without papillary disease.

As part of the Cancer BioShield program, NAI “proliferates natural killer (NK) cells and CD4+ and CD8+ T cells, restoring lymphocyte levels critical for immunosurveillance, immunogenic cell death, and long-term tumor control,” ImmunityBio explained.

According to the company, the platform includes the following:

“In-vivo stimulation: Subcutaneous administration of ANKTIVA expands NK and T cells, boosting anti-tumor immunity.

Ex-vivo targeted cytotoxicity: Off-the-shelf PD-L1 t-haNK CAR-NK cells are engineered to target and eliminate PD-L1–expressing tumor cells and immunosuppressive neutrophils (myeloid-derived suppressor cells), enhancing anti-tumor specificity and reducing immune evasion.

Memory Cytokine-Enriched Natural Killer (M-ceNK) cell therapy: M-ceNK cells are developed via cytokine activation and expansion of autologous and allogeneic NK cells collected through apheresis, potentially providing long-term immune memory and sustained cytotoxic capacity.”

The BioShield platform was granted a Regenerative Medicine Advanced Therapy designation by the FDA in February 2025 for the management of lymphopenia.

For decades, epoetin alfa (epogen) and filgrastim (neupogen) have been used to treat patients with chemotherapy- and radiation-induced anemia and neutropenia, respectively. However, there has been no comparable option available for the management of lymphopenia.

®, Soon-Shiong explained, “To this day, there's never been a molecule, a fusion protein, that rescues lymphocytes, the NK cells and T cells, which are the key cells for killing cancer and generating memory. For the first time, this is Anktiva.”

Data from the phase 2 QUILT-88 study (NCT04390399) were recently presented at the 

2025 American Society of Clinical Oncology Annual Meeting

 Overall, the trial was assessing the use of NAI and PD-L1-targeted high-affinity NK cell therapy (PD-L1 t-haNK) in combination with low-dose chemotherapy in patients with locally advanced or metastatic pancreatic cancer.

Data showed that the chemo-immunotherapy protocol led to a median overall survival (OS) of 6.2 months (95% CI, 5.0 to 7.1) in the 3

 line setting and 5.7 months (95% CI, 4.3 to 6.4) in the 3

 line setting. According to the authors, a median OS exceeding 6 months is roughly 2 months greater than the OS achieved by other therapies in the 3

Additionally, a higher absolute lymphocyte count (ALC) was associated with greater survival. Median OS was 7.1 months in patients with an ALC of 1.045 x 109 cells/L or higher and a CA19-9 less than 4079.6 U/mL compared with a median OS of 3.1 months for patients with an ALC less than 1.045 x 109 cells/L and a CA19-9 of 4079.6 U/mL or higher (HR, 3.6; 

Grade 3 or higher treatment-emergent adverse events occurred in 95% of patients. These were largely attributed to chemotherapy, according to the authors.

“Lymphopenia has long been recognized as a major driver and predictor of early mortality in cancer—yet until now, it has remained unaddressed,” said Patrick Soon-Shiong, MD, founder, executive chairman, and global chief scientific and medical officer of ImmunityBio, in the news release.

 “This FDA authorization allows all patients with solid tumors suffering from immune collapse following first-line therapy of chemo, radiation, or immunotherapy to access ANKTIVA. The survival benefit we observed at ASCO 2025 in 3rd to 6th line advanced metastatic pancreatic cancer confirms that restoring lymphocyte levels—rather than depleting them—can change the course of disease.”

1. ImmunityBio receives FDA Expanded Access authorization for landmark treatment of lymphopenia with ANKTIVA, the Cancer BioShield Platform, in patients with solid tumors. News release. ImmunityBio. June 2, 2025. Accessed June 7, 2025. https://immunitybio.com/immunitybio-receives-fda-expanded-access-authorization-for-landmark-treatment-of-lymphopenia-with-anktiva-the-cancer-bioshield-platform-in-patients-with-solid-tumors/

The FDA has authorized an Expanded Access Program for nogapendekin alfa inbakicept-pmln (NAI; Anktiva) to manage lymphopenia in patients with refractory or relapsed solid tumors. This program utilizes ImmunityBio’s Cancer BioShield platform, which enhances NK and T cell proliferation, crucial for immunosurveillance and tumor control. Data from the QUILT-88 study showed improved median overall survival in advanced pancreatic cancer patients using NAI and PD-L1-targeted NK cell therapy. The program addresses the unmet need for lymphopenia management, offering potential survival benefits in solid tumor patients.

The Cancer BioShield platform is being assessed as a treatment for lymphopenia in adult patients with refractory or relapsed solid tumors, including genitourinary tumors.

Antony Mathew, MD

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