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“The differences in patient experience between UroLift System and Rezūm, particularly in terms of early recovery, sexual function, and overall satisfaction, are key considerations for both clinicians and patients selecting a treatment path," says Mark Rochester, MD, FRCS. 

UroLift may offer improved early recovery period vs Rezūm for BPH 

"The Inflation Reduction Act was a major step in the right direction. The question now is going to be, are commercial insurers going to follow Medicare and enact the same cap that they have as well," says Benjamin Pockros, MD, MBA.

Cutting drug costs for patients: key takeaways for urologists

"The combination demonstrated clinical activity and an acceptable safety profile in the perioperative setting for locally advanced, non-metastatic clear cell RCC," says Mehmet Asim Bilen, MD. 

Perioperative lenvatinib/pembrolizumab shows promise in non-metastatic ccRCC

The company plans to initiate the phase 2 monotherapy trial by mid-year. 

CD46-targeting ADC shows encouraging clinical activity in mCPRC

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Authors

Davis is an associate professor of medicine and urology and vice president for Cancer Care Network and Strategy at Vanderbilt University Medical Center, Nashville, Tennessee.

Multiple investigational agents have been developed and are being studied.

BCG-unresponsive NMIBC: Current evidence and options

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

Data from the phase 3 TALAPRO-2 trial (NCT03395197) showed that the combination of enzalutamide (Xtandi) plus talazoparib (Talzenna) led to a statistically significant and clinically meaningful improvement in overall survival (OS) vs enzalutamide alone in patients with metastatic castration-resistant prostate cancer (mCRPC).

 These data were recently presented at the 

2025 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium

, shares the OS results in patients stratified by HRR gene mutation status. Overall, both HRR mutation-negative and HRR mutation-positive patients demonstrated an improvement in OS with the combination vs enzalutamide alone, though the benefit was more pronounced in those who had HRR mutations.

Agarwal is professor of medicine and the director of the genitourinary oncology program at the Huntsman Cancer Institute of the University of Utah in Salt Lake City.

Neeraj Agarwal, MD, FACS, shares the OS results in patients stratified by HRR gene mutation status. 

Neeraj Agarwal, MD, on talazoparib/enzalutamide efficacy by HRR gene mutation status

In the subgroup analysis, the addition to talazoparib improved OS in patients who were HRR-deficient (n = 169; HR, 0.549; 95% CI, 0.364–0.826; 

= .0035) and in patients who were HRR–non-deficient/unknown (n = 636; HR, 0.878; 95% CI, 0.713–1.080; 

According to Agarwal, in the patients who did the not have HRR mutations, the OS was 46.6 months in the combination arm vs 37.4 months in the enzalutamide alone arm. Among those who did have HRR mutations, the OS was 45 months in the combination arm vs 31 months in the enzalutamide alone arm.

Agarwal concluded, “These are all meaningful improvement in survival, although survival advantage is more in patients who had HRR gene mutations. That’s why we should continue to obtain comprehensive genomic profiling or NGS testing for all patients with metastatic prostate cancer.”

1. Agarwal N, Azad A, Carles J, et al. Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as first-line treatment in unselected patients with metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 TALAPRO-2 trial. 

. 43, 2025 (suppl 5; abstr LBA18). doi:10.1200/JCO.2025.43.5_suppl.LBA18

"We see the overall survival, whether it is [in] all-comers, in HRR gene mutation-positive patients, or in HRR gene [mutation]-negative patients or [those] who did not have mutations, the overall survival is about 45 to 47 months," says Neeraj Agarwal, MD, FACS. 

Patients with benign prostatic hyperplasia (BPH) who underwent treatment with Aquablation achieved similar short-term symptom improvement to those who underwent transurethral laser enucleation of large prostates (LEP; 80 to 180 mL) while demonstrating lower rates of ejaculatory dysfunction and stress incontinence, according to 3-month data from the WATER III trial (NCT04801381).

However, patients who underwent LEP demonstrated superior outcomes regarding prostate volume reduction and urinary flow rate improvement.

The data were presented by Manuel Ritter, MD, at the 40

 Annual European Association of Urology Congress in Madrid, Spain. Ritter explained that since the WATER I and WATER II trials, Aquablation has been adapted to improve bleeding rates seen in larger prostates through the integration of electrocautery. Laser enucleation, at the same time, has become a gold standard approach due to its benefits over simple prostatectomy, but the procedure comes with a steep learning curve.

“It was the logical consequence to test these 2 techniques [at] the highest level possible: a prospective trial with randomized patients,” he stated.

Thus, the WATER III trial enrolled 202 patients with BPH and a prostate size between 80 mL to 180 mL. The study included randomized and non-randomized cohorts.

“The Bayesian statistical model allows us to borrow strength from the randomized cohort to the non-randomized cohort,” Ritter explained. “The other patients not being willing to consent to randomization have been offered to be part of the non-randomized cohort.”

In the randomized cohort, 35 patients were randomly assigned to Aquablation, and 32 patients were randomly assigned to holmium/thulium LEP (HoLEP/ThuLEP). In the non-randomized cohort, 63 patients elected to undergo Aquablation, and 56 patients elected to undergo LEP. In total, 98 patients in the Aquablation arm and 88 patients in the LEP arm were treated.

Demographics of each cohort were largely similar across arms, with the only notable difference being in age. The mean age was 65.2 years among patients who underwent Aquablation vs 67.5 years among patients who underwent LEP (

 = .02). The average duration of the procedure was 58.1 minutes in the Aquablation arm and 61.8 minutes in the LEP arm (

Aquablation demonstrated non-inferiority to LEP regarding the study’s primary end point of mean change in International Prostate Symptom Score (IPSS). Specifically, the change in IPSS from baseline to 3 months was 12.9 in the Aquablation arm vs 13.1 in the LEP arm (mean delta, 0.86; 95% CI, -1.6 to 3.2; 

 = .745). In the Aquablation arm, the baseline IPSS was 20.7, which decreased to 9.1 at 3 months. In the LEP arm, the baseline IPSS was 21.5, which decreased to 9.3 at 3 months.

Regarding the study’s secondary end points, urinary flow rate improvement (Qmax) from baseline to 3 months was greater in the LEP arm (

 < .0001). Patients in the LEP arm also saw a greater reduction in post-void residual (

 = .2956). However, patients in the Aquablation arm achieved a greater reduction in prostate size (

Clavien-Dindo (CD) grade 2 or higher or persistent grade 1 adverse events were reported in 38.8% of patients in the Aquablation arm vs 54.5% of patients in the LEP arm (estimated mean difference, -10%; 95% CI, -34% to 13%; P < .05).

Ritter added, “Higher grade complications were rare in both groups, with 8.2% in the Aquablation group and 5.6% in the laser enucleation group. One patient had to stay for 1 night on ICU due to hypovolemia.”

Bleeding risk was comparable between both arms. However, patients in the Aquablation arm achieved superior outcomes regarding sexual function and urinary incontinence following surgery.

Specifically, ejaculatory dysfunction in the 3 months following surgery was reported in 14.8% of patients in the Aquablation arm vs 77.1% of patients in the LEP arm (

 < .0001). Urinary incontinence was also lower in the Aquablation arm, with a rate of 8.7% compared with 20.0% among patients who underwent LEP (

 = .0690). On this, no patients reported stress urinary incontinence in the Aquablation arm, compared with 9.1% of patients in the LEP arm (

Ritter also noted, “Despite excluding UTI before surgery and giving antibiotic prophylaxis up to the standard of each study center, 29% of Aquablation patients and 24% of laser enucleation patients received antibiotic treatment during the 3 months after surgery.”

Patients included in this trial are expected to undergo follow-up for up to 5 years.

“The WATER III results are impressive, demonstrating that Aquablation therapy can achieve outcomes comparable to laser enucleation,” said Naeem Bhojani, MD, FRCSC, of the University of Montreal, in a news release on the findings.

 “The consistent efficacy coupled with the significantly lower rates of ejaculatory dysfunction and stress incontinence represents a meaningful advancement for patients seeking treatment for BPH. The effectiveness of Aquablation therapy is shown by its ability to achieve similar results as highly skilled and experienced laser enucleation surgeons.”

1. Ritter M, Stein J, Barber N, et al. WATER III: Aquablation vs. Transurethral laser enucleation of large prostates (80-180ml) in benign prostatic hyperplasia. Presented at 40

 Annual European Association of Urology Congress. Madrid, Spain. March 21-24, 2025. Abstract GC4

2. WATER III randomized-controlled trial results announced at European Association of Urology comparing Aquablation therapy to laser enucleation. News release. PROCEPT BioRobotics. Published online and accessed March 24, 2025. https://www.globenewswire.com/news-release/2025/03/24/3047778/0/en/WATER-III-Randomized-Controlled-Trial-Results-Announced-at-European-Association-of-Urology-Comparing-Aquablation-Therapy-to-Laser-Enucleation.html

Aquablation and transurethral laser enucleation of large prostates (LEP) offer similar short-term symptom relief for benign prostatic hyperplasia (BPH), with Aquablation showing lower rates of ejaculatory dysfunction and stress incontinence. LEP, however, provides superior prostate volume reduction and urinary flow rate improvement. The WATER III trial, involving 202 patients, demonstrated Aquablation's non-inferiority to LEP in symptom score changes. Aquablation also resulted in fewer adverse events and better sexual function outcomes. Both treatments had comparable bleeding risks, with follow-up planned for up to five years.

The mean change in IPSS from baseline to 3 months was 12.9 in the Aquablation arm vs 13.1 in the LEP arm.

WATER III: Aquablation achieves comparable outcomes to laser enucleation for BPH

Current and Emerging Treatment Landscape of mHSPC

Jack Andrews MD; Eugene Cone, MD; and Arash Rezazadeh, MD, discuss how metastatic hormone-sensitive prostate cancer presents clinically, explore current treatment standards including combination therapies, evaluate emerging data from the ARANOTE trial on darolutamide efficacy, consider quality of life factors in treatment selection, and examine how novel therapeutic approaches may reshape future care pathways.

Current and Emerging Treatment Landscape of mHSPC 

The policy environment surrounding telehealth is a volatile one, according to 

. While legislators have made several decisions to extend telehealth flexibilities that were implemented during the COVID-19 pandemic, they have failed to pass any language to secure its permanent coverage.

Given this uncertainty, urologists and other health care professionals may feel unsure on how to incorporate telehealth in their practice. After all, Congress must decide on telehealth’s future yet again by the end of September, or else these provisions will expire.

®, Ellimoottil offered reassuring advice to urologists who are unsure of how to approach telehealth in this shaky environment: continue with the mindset of business as usual. 

Chad Ellimoottil, MD, MS, offered reassuring advice to urologists who are unsure of how to approach telehealth in this shaky environment.

Chad Ellimoottil, MD, on how urologists should approach telehealth in changing policy environment

According to Ellimoottil, there is large support to continue coverage of telehealth flexibilities into the future, which make him optimistic about the potential for permanent coverage.

“People have seen the benefits of telehealth [and] practices have seen the benefits of telehealth over the last 4 years,” he said. “Folks do want to keep it the same. I think that it's very non-controversial from that standpoint.”

However, there are some areas of dissension, he explained.

“The areas where there is a little bit more debate are around how to create guardrails, or how to make sure that there's not a lot of fraud and abuse, so that's where the attention is. Fortunately, there [have] been big studies like from the Office of Inspector General that have found very little fraud and abuse among telehealth providers like us.”

Data such as these will help to inform telehealth's future.

"I say with a lot of confidence, just continue using telehealth as you are," says Chad Ellimoottil, MD, MS.

Nancy B. Davis, MD

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