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

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

FDA authorizes Expanded Access Program of Anktiva for lymphopenia

professor and chair of urology at the University of Oklahoma Health Sciences Center in Oklahoma City, is co-editor in chief of 

"As clinicians, researchers, and advocates, this moment invites us to reflect on how far we’ve come—and how much further we must go," writes Michael S. Cookson, MD, MMHC, FACS.

Prostate cancer awareness in 2025: A human imperative in the wake of President Biden’s diagnosis

Data from the #HOPE4KIDNEY trial is intended to support submission for regulatory clearance of the Edison Histotripsy System.

Pivotal trial of histotripsy system for kidney tumors reaches enrollment goal

Data showed that Non-Hispanic Black and Latinx/Hispanic patients were less likely to receive PSMA-PET imaging than non-Hispanic White patients. 

Study finds racial/ethnic disparities in use of PSMA-PET in prostate cancer

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In these videos, expert surgeons demonstrate robot-assisted penile inversion vaginoplasty, single-stage metoidioplasty, and simple orchiectomy for transgender patients.

Transgender surgery: Videos demonstrate cutting-edge techniques

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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. 

News

FDA accepts BLA for subcutaneous nivolumab in solid tumors

Data from the phase 3 AMPLITUDE trial (NCT04497844) showed that adding niraparib (Zejula) to abiraterone acetate (Zytiga) plus prednisone (AAP) led to a statistically significant improvement in radiographic progression-free survival (rPFS) vs placebo plus AAP in patients with metastatic castration sensitive prostate cancer (mCSPC) and homologous recombinant repair (HRR) gene mutations.

2025 American Society of Clinical Oncology (ASCO) Annual Meeting

 in Chicago, Illinois, suggest that the greatest rPFS benefit with the niraparib regimen is in those with 

Overall, the addition of niraparib to AAP was shown to reduce the risk of radiographic progression or death by 37% among patients in the intent-to-treat population (HRR mutations) and by 48% in patients with 

Among those with HRR mutations (ITT), the median rPFS was not met in the niraparib plus AAP arm, compared with 29.5 months in the placebo plus AAP arm (HR, 0.63; 95% CI, 0.49 to 0.80; 

 = .0001). In those with BRCA mutations, the median rPFS was not reached in the niraparib plus APP arm vs 26 months in the placebo plus APP arm (HR, 0.52; 95% CI, 0.37 to 0.72; 

Gerhardt Attard, MD, FRCP, PhD, who presented results at ASCO, noted during the presentation, “AMPLITUDE met its primary end point of radiographic progression free survival. This makes it the first trial to show efficacy for the combination of inhibition of PARP and the androgen receptor pathway in metastatic castration-sensitive prostate cancer with alterations in genes involved in homologous recombination repair, with greatest benefit apparent in patients with 

In total, the AMPLITUDE trial enrolled 696 patients who were randomly assigned to receive 200 mg niraparib plus 1000 mg abiraterone acetate plus 5 mg prednisone once daily (n = 348) or to matched placebo plus 1000 mg abiraterone acetate plus 5 mg prednisone once daily. Patients in both arms were allowed to receive androgen deprivation therapy for up to 6 months.

Participants were eligible for enrollment in the study if they had an alteration in at least 1 HRR eligible gene, which included: 

. Patients also needed to have an ECOG performance score between 0 and 2.

The trial’s primary end point is rPFS. Key secondary end points include time to symptomatic progression, overall survival (OS), and safety.

Additional data from the trial showed that the benefit of niraparib to APP was generally consistent across all pre-specified subgroups.

Attard noted, “There are a couple of subgroups that have small numbers of events, notably patients presenting with metachronous disease and the subgroups split by geographical region.”

The addition of niraparib also reduced the risk of symptomatic progression by 50% in the ITT population (HR, 0.50; 95% CI, 0.36 to 0.69; 

 < .0001) and 56% in the BRCAm cohort (HR, 0.44; 95% CI, 0.29 to 0.68; 

 = .0001). At the time of data report, the median time to symptomatic progression was not reached in either arm in either the ITT population or in the BRCAm population.

Attard also reported, “At this first interim analysis for overall survival, we have about 50% of the number of deaths that will be required for final analysis, but estimates favor the addition of niraparib [to] AAP.”

Overall, the addition of niraparib to AAP was shown to reduce the risk of death by 21% in the HRRm population (HR, 0.79; 95% CI, 0.59 to 1.04; 

 = .10) and 25% in the BRCAm population (HR, 0.75; 95% CI, 0.51 to 1.11; 

, there were 7 other HRR genes that allowed patients to be eligible for the trial,” Attard added. “Gene subgroups are small and were not pre-powered for formal analysis, but you'll appreciate probable heterogeneous effect across these single gene groups. I would expect that in the future, combinations with other trials, possibly using meta-analysis approaches, will give us greater certainty for the sensitivity of individual gene groups to PARP inhibition in this disease setting.”

The majority of patients who discontinued treatment due to progression went on to receive a subsequent therapy. There were comparable rates of subsequent therapy between the 2 arms with the exception of subsequent PARP inhibition, reported in 11% of patients in the niraparib arm vs 36% of patients in the placebo arm.

Regarding safety, grade 3 to 4 treatment-emergent adverse events (AEs) were reported in 75% of patients in the niraparib arm vs 59% in the placebo arm. The investigators also noted a less than 5% increase in the rate of discontinuation due to toxicity with niraparib vs placebo (15% vs 10%, respectively).

The most common grade 3 or higher AE was anemia, reported in 29% of patients in the niraparib arm vs 5% of patients in the placebo arm. Grade 3 or higher hypertension was also reported in 27% of patients in the niraparib arm vs 18% of patients in the placebo arm.

Other common AEs of any grade included constipation (35% vs 16%), nausea (31% vs 14%), fatigue (26% vs 18%), and arthralgia (21% vs 21%) in the niraparib vs placebo arms, respectively.

Based on these data, the authors concluded, “AMPLITUDE supports early genomic testing and niraparib plus AAP as a new treatment option for patients with mCSPC and HRR gene alterations.”

1. Attard G, Agarwal N, Graff J, et al. Phase 3 AMPLITUDE trial: Niraparib (NIRA) and abiraterone acetate plus prednisone (AAP) for metastatic castration-sensitive prostate cancer (mCSPC) patients (pts) with alterations in homologous recombination repair (HRR) genes. 

. 2025;43 (suppl 17; abstr LBA5006). Doi: 10.1200/JCO.2025.43.17_suppl.LBA5006

The phase 3 AMPLITUDE trial demonstrated that adding niraparib to abiraterone acetate plus prednisone significantly improved radiographic progression-free survival in patients with metastatic castration-sensitive prostate cancer and homologous recombinant repair gene mutations. The greatest benefit was observed in patients with BRCA mutations. The trial met its primary endpoint, showing a 37% risk reduction in radiographic progression or death in the intent-to-treat population and 48% in the BRCA mutation cohort. Safety data indicated higher rates of grade 3-4 adverse events in the niraparib arm, with anemia being the most common.

“AMPLITUDE supports early genomic testing and niraparib plus AAP as a new treatment option for patients with mCSPC and HRR gene alterations," the authors wrote.

Adding niraparib to AAP extends rPFS in HRR-positive mCSPC

Five-year data from the phase 3 ARCHES trial (NCT02677896) showed that enzalutamide (Xtandi) plus androgen deprivation therapy (ADT) continued to provide a substantial and durable benefit in overall survival (OS) vs placebo plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

2025 American Society of Clinical Oncology Annual Meeting

At a median follow-up of 61.4 months, enzalutamide plus ADT was associated with a 30% reduction in the risk of death vs placebo plus ADT (HR, 0.7; 95% CI, 0.58 to 0.85; 

 = .001). The probability of survival at 5 years was 65.5% (95% CI, 61.2 to 69.5) in the treatment arm vs 53.4% (95% CI, 48.5 to 57.9) in the control arm.

The median survival was not reached in either arm. In the placebo arm adjusted for crossover, the median OS was 59.5 months (95% CI, 49.7 to NE).

According to lead author Andrew J. Armstrong, MD, MSc, of the Duke Cancer Institute, who presented results on behalf of the ARCHES investigators, “[These data] represent one of the longest overall survival follow-up analyses in this hormone-sensitive setting.”

In total, the ARCHES trial enrolled 1150 patients with mHSPC who were randomly assigned 1:1 to receive 160 mg enzalutamide once daily plus ADT (n = 574) or placebo plus ADT (n = 576). Following the primary analysis of the data, 182 patients in the placebo arm crossed over to the treatment arm.

The primary end point for the trial was radiographic progression-free survival (rPFS). Key secondary end points included OS, prostate-specific antigen (PSA) PFS, time to initiation of new antineoplastic therapy, undetectable PSA rate, objective response rate, and time to deterioration in urinary symptoms.

Data were stratified by disease volume (low vs high) and prior docetaxel use for mHSPC. Across all subgroups, enzalutamide plus ADT demonstrated a survival advantage vs placebo plus ADT.

In patients with high-volume disease, the median OS at 5 years was 83.06 months (95% CI, 69.59 to NE) in the enzalutamide arm vs 47.57 months (95% CI, 40.11 to 75.66) in the placebo arm (HR, 0.70; 95% CI, 0.56 to 0.88).

Armstrong noted, “This represents a 36-month extension of overall survival for these high-volume patients that have a major unmet medical need.”

The 5-year survival rate amongst patients with high-volume disease was 58.4% with enzalutamide vs 45% with placebo.

There was a similar relative improvement in OS in patients with low-volume disease (HR, 0.71’ 95% CI, 0.49 to 1.05). At the time of data report, the median survival had not been reached in either arm. The 5-year survival rate was 76.7% in the enzalutamide arm vs 67.5% in the placebo arm.

Among patients with de novo high-volume synchronous disease, the median OS was 81.97 months in the enzalutamide arm vs 44.16 months in the placebo arm (HR, 0.71; 95% CI, 0.56 to 0.91). The median OS has not yet been reached in either arm for patients with low-volume synchronous disease (HR, 0.70; 95% CI, 0.45 to 1.07).

Armstrong also noted, “Prior docetaxel actually had one of the greatest survival benefits of any subgroup.”

In patients who had received prior docetaxel, the 5-year survival rate was 66.3% in the enzalutamide arm vs 49.8% in the placebo arm. In patients who had not received prior docetaxel, these rates were 65.4% and 54.2%, respectively.

The OS benefit with enzalutamide remained consistent across most prespecified subgroups, regardless of age, geography, ECOG performance status, and baseline PSA.

Overall, the median duration of treatment was 41.7 months in the enzalutamide arm, 13.8 months in the placebo arm, and 44.2 months in the placebo crossover arm. The incidence of treatment-emergent adverse events (TEAEs) was similar across all treatment groups.

Grade 3 to 4 TEAEs occurred in 46% of patients on enzalutamide plus ADT vs 28.4% of patients in placebo plus ADT. TEAEs associated with enzalutamide were mostly reported in the first couple of years and tended to diminish substantially over time.

TEAEs of special interest occurred in 75.9% of patients in the treatment arm vs 57.1% of patients in the control arm. The incidence of TEAEs of special interest was consistent with previously reported data from ARCHES.

No new safety signals with the combination were identified.

According to the authors, these data continue to support enzalutamide plus ADT as a standard-of-care for patients with mHSPC.

“The 5-year survival with enzalutamide and ADT in the ARCHES study shows an absolute benefit of 13% at 5 years,” Armstrong concluded during the presentation. “The [survival] benefit ranges from about 9% to 17% and was observed regardless of disease volume, prior docetaxel, and synchronous or metachronous disease. This improvement in long-term survival is accompanied by an increase in enzalutamide-related treatment-emergent adverse events, which are manageable. It does suggest the need for long-term survivorship management—exercise, bone health monitoring, blood pressure monitoring in particular—but these tend to diminish over time with good management.”

1. Armstrong A, Petrylak D, Shore N, et al. ARCHES: 5-year follow-up overall survival (OS) analysis of enzalutamide (ENZA) plus androgen-deprivation therapy (ADT) in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC). 

. 2025;43(suppl 17):5005. doi:10.1200/JCO.2025.43.16_suppl.5005

The phase 3 ARCHES trial demonstrated that enzalutamide combined with androgen deprivation therapy (ADT) significantly improves overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to placebo plus ADT. At a median follow-up of 61.4 months, enzalutamide plus ADT reduced the risk of death by 30%. The 5-year survival rate was 66.5% for the treatment group versus 53.4% for the control group. The survival benefit was consistent across various subgroups, including those with high-volume disease and prior docetaxel use, despite increased treatment-emergent adverse events.

According to the authors, these data continue to support enzalutamide plus ADT as a standard-of-care for patients with mHSPC. 

Enzalutamide plus ADT continues to show durable survival benefit in mHSPC at 5 years

 suggest that the use of combination therapy in veterans with de novo metastatic-hormone sensitive prostate cancer (mHSPC) has increased over time and is associated with significantly longer overall survival (OS) vs androgen-deprivation therapy (ADT) monotherapy.

"Frequently new drugs work [well] in clinical trials and have little effect in the real world. In most clinical trials patients are younger (age 65-70) and predominantly White (<4% Black men) who can travel to high-end academic medical centers and are more physically fit," explained lead author Martin W. Schoen, MD, MPH, of Saint Louis University and St. Louis Veterans Affairs Medical Center, in correspondence with 

. "Our data comes from the entire VA, which includes ~25% Black men and men who are age 70-75 with heart disease, diabetes, etc. We show that in a real world population, the new therapies are effective. This study shows that the benefits of therapies in clinical trials is translating to benefits in the real world in a large group of patients."

In total, the retrospective cross-sectional study assessed 6216 veterans who received a diagnosis of de novo mHSPC from January 2013 to December 2022. The mean age of patients was 73.9 years (SD, 9.7). Among the 6216 patients included in the analysis, 3839 (61.8%) received ADT monotherapy, 1719 (27.7%) received an ARPI combination, and 658 (10.6%) received a docetaxel combination.

Overall, data showed an increase in the use of combination therapy over time, with combination treatment with either an ARPI or docetaxel becoming the majority of treatment in 2020. In 2020, combination therapy was used in 54% of patients (344 of 637), which rose to 63.1% of patients (465 of 737) in 2022.

Combination therapy was also associated with a significantly longer OS vs ADT monotherapy. Specifically, the mean OS was 40.3 months with combination therapy compared with 33 months with ADT monotherapy (HR, 0.80; 95% CI, 0.74 to 0.87).

There was no difference in OS between ARPI-based and docetaxel-based combination regimens. The mean OS was 40.4 months with ARPI combination therapy vs 40.2 months with docetaxel combination therapy (HR, 1.06; 95% CI, 0.92 to 1.22).

The study also assessed outcomes among 1540 patients who received combination therapy and had imaging reports for volume of disease. Those with high-volume disease demonstrated a significantly shorter survival; the mean OS was 33.3 months among those with high-volume disease compared with 62.5 months among those with low-volume disease (HR, 0.51; 95% CI, 0.43 to 0.60; 

Patients with high-volume disease were also more likely to receive combination therapy with docetaxel. Overall, 33.8% of patients with high-volume disease received docetaxel combination therapy vs 22.1% of patients with low-volume disease (

In patients with high-volume disease, data showed no difference in OS between those who received an ARPI combination vs those who received a docetaxel combination. Specifically, OS was 32.2 months among those who received an ARPI combination vs 34.7 months among those who received a docetaxel combination (HR, 1.06; 95% CI, 0.91 to 1.23).

However, in those with high-volume disease, combination therapy with an ARPI was associated with a longer progression-free survival (PFS) vs combination therapy with docetaxel. The mean PFS was 18.7 months with an ARPI combination vs 16.0 months with a docetaxel combination (HR, 0.80; 95% CI, 0.70 to 0.91).

Trends were similar in patients with low-volume disease. Data showed no difference in OS between those who received an ARPI vs docetaxel regimen (68.4 months vs 55.3 months; HR, 0.81; 95% CI, 0.58 to 1.13), but PFS was significantly longer among those who received an ARPI regimen. Specifically, the mean PFS was 39.7 months in those who received an ARPI combination vs 24.0 months in those who received a docetaxel regimen (HR, 0.57; 95% CI, 0.43 to 0.76).

"This research shows that these drugs have a dramatic effect on average patients in the VA, a group that is hard to treat," Schoen added. "This is the first large study that I am aware of that has compared chemotherapy vs hormonal therapies in matched patients in routine clinical practice."

The authors also concluded, “The data presented here suggest that an ARPI doublet combination treatment that avoids chemotherapy is a standard of care, and there is little evidence of benefit associated with a docetaxel doublet compared with an ARPI doublet."

“Future research into the role of docetaxel in triple combination is needed to elucidate the benefit of chemotherapy in mHSPC," they added.

1. Schoen MW, Doherty J, Eaton D, et al. Treatment patterns and survival among veterans with de novo metastatic hormone-sensitive prostate cancer. 

. 2025;8(5):e259433. doi:10.1001/jamanetworkopen.2025.9433

2. Treatment patterns, survival among veterans with de novo metastatic hormone-sensitive prostate cancer. News release. Saint Louis University. May 7, 2025. Accessed May 27, 2025. https://www.newswise.com/articles/treatment-patterns-survival-among-veterans-with-de-novo-metastatic-hormone-sensitive-prostate-cancer

Combination therapy for veterans with de novo metastatic hormone-sensitive prostate cancer (mHSPC) has increased over time, leading to significantly longer overall survival (OS) compared to androgen-deprivation therapy (ADT) monotherapy. The study analyzed 6216 veterans, revealing that combination therapy became predominant by 2020. No OS difference was found between androgen receptor pathway inhibitors (ARPI) and docetaxel combinations, but ARPI showed longer progression-free survival (PFS). High-volume disease patients had shorter OS, with docetaxel more frequently used. Future research is needed to explore docetaxel's role in triple combination therapies.

However, the data did not show any benefit of a docetaxel doublet vs an ARPI doublet.

Lee Zhao, MD

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