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 “On the intention-to-treat efficacy analysis...the median PFS was numerically higher for the paclitaxel arm," said Aditya Dhanawat, MBBS, MD, DM.

RCT compares platinum/5-FU, platinum/paclitaxel in high-risk penile cancer

A recap of the FDA submissions and regulatory decisions in urology from May 2025.

FDA updates in urology: May 2025

The findings also lend further credence to the muscle-invasive bladder cancer treatment regimen, investigators reported.

NIAGARA: ctDNA analysis highlights durvalumab’s impact in MIBC

"This final analysis of this study continues to support nivo+ipi as a standard of care for patients with untreated RCC," says Robert J. Motzer, MD. 

Nivolumab/ipilimumab continues to show improved survival, durable response in aRCC

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“Some of the main implications for urologists is that the risk adapted utilization of BCG, which has been implemented as guidelines, should continue,” says Madison M. Wahlen.

Madison Wahlen on navigating the impact of the BCG shortage

"We found that patients whose care was impacted by shortages did not have statistically significantly worse recurrence outcomes compared to patients whose care was not impacted by shortages," says Madison M. Wahlen. 

Madison Wahlen on the BCG shortage’s impact on NMIBC outcomes

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

Findings from the phase 3 CREST (NCT04165317) study indicate significantly prolonged event-free survival (EFS) with sasanlimab plus BCG compared with BCG alone in patients with high-risk non–muscle invasive bladder cancer (NMIBC).

Neal D. Shore, MD, FACS, director of the Carolina Urologic Research Center in Myrtle Beach, South Carolina, presented the data during a plenary session at the 

2025 American Urological Association (AUA) Annual Meeting

“The [mechanism of action] for combining BCG with a PD-1 blocker has been well established up-regulating PD, and therefore the synergistic effect of adding a PD blocker. Of note, sasanlimab is delivered subcutaneously, which may be actually very advantageous for certain clinics, both [medical oncology] and [urology].”

The CREST study included 1055 patients with BCG-naïve, high-risk NMIBC that is high-grade Ta and/or carcinoma in situ (CIS) and had not received prior PD-(L)1, PD-L2, or CTLA-4 inhibitors or immunostimulatory agents. They were randomly assigned 1:1:1 to arm A (sasanlimab plus BCG induction and maintenance), arm B (sasanlimab plus BCG induction), and arm C (BCG induction plus maintenance). The primary end point was EFS for arm A vs arm C. Key secondary end points included EFS in arm B vs arm C, and overall survival (OS). Select secondary end points included complete response (CR) in patients with CIS, duration of CR in patients with CIS, safety, and quality of life.

A total of 352 patients were included in arm A and 351 were included in arm C. Median patient age was 67 years in both arms. A total of 280 (79.5%) and 284 (80.9%) patients were male in arms A and C, respectively. A total of 225 (63.9%) and 210 (59.8%) of patients were Caucasian in arms A and C, respectively, and 115 (32.7%) and 126 (35.9%) were Asian.

Regarding disease stage, “55% or higher were T1 patients. Twenty-five percent of this population was CIS, of which 15% was strictly CIS by itself. Looking at the patients and their maintenance of similar rates of BCG, if you look at the discontinuation rates, they're relatively comparable in the combination arm and the BCG arm. What that tells me is that adding sasanlimab did not impact the ability to deliver induction and maintenance BCG,” Shore said.

Shore reported that the risk of experiencing an EFS event was 32% lower in arm A vs arm C (HR=0.68; 95% CI: 0.49-0.94, 1-sided 

value=.0095). Recurrence of high-grade disease was observed in 26 (7.4%) patients in arm A vs 53 (15.1%) patients in arm C. Persistence of CIS was seen in 1 (0.3%) patient in each arm.

EFS was not found to be different between arm B and arm C. “The take-home for this is that BCG maintenance is effective and does matter,” Shore said. He also reported no meaningful difference between treatment arms when it came to interim OS.

Shore also highlighted CR and duration of response in patients with CIS. “In the patients with CIS, the probability of a continued complete response at 36 months was 92% vs 67.7%. I think that's a rather compelling finding,” Shore said.

In terms of adverse events, the safety profile was reported to be consistent with the known safety profile for each agent.

“We didn't find anything that we hadn't anticipated for this class of therapies, whether it was BCG or a checkpoint inhibitor,” Shore said.

In addition, quality of life was maintained for patients receiving sasanlimab in combination with BCG induction plus maintenance.

“In conclusion, this is the first [of 4 large phase 3 trials evaluating checkpoint blockade in BCG-naïve patients] to show and report here at the AUA 2025…a statistically significant prolongation of EFS with sasanlimab in combination with BCG. [In] patients with CIS the probability of continued CR was greater for the combination—92% vs 68% at 36 months. The safety profile was as expected. I think it's important to recognize the unique subcutaneous administration, and very importantly, that we will need continued collaborative, multi-disciplinary efforts to make sure and optimize shared decision-making for patients who are at risk,” Shore concluded.

In a news release about the results, Megan O’Meara, MD, Interim Chief Development Officer of Pfizer Oncology commented, “Today’s pivotal phase 3 CREST results offer a much-needed therapeutic breakthrough and spotlight sasanlimab as the first immunotherapy combination with BCG to significantly improve outcomes for patients with BCG-naïve, high-risk NMIBC in over three decades. The CREST findings are especially impactful for these patients with early-stage cancer who may benefit the most from innovative treatment regimens, including a subcutaneous immune checkpoint inhibitor, that delay disease recurrence or progression. These results underscore our long-standing commitment to patients with bladder cancer across all stages of the disease. We look forward to working with global regulatory authorities to potentially bring sasanlimab as an important new treatment option to patients with high-risk NMIBC.”

1. Shore ND, Powles T, Bedke J, et al. Sasanlimab in combination with Bacillus Calmette-Guérin improves event-free survival versus Bacillus Calmette Guérin as standard of care in high-risk non-muscle invasive bladder cancer: Phase 3 CREST study results. 

2. Pfizer’s sasanlimab combination significantly improves event-free survival in BCG-naïve, high-risk non-muscle invasive bladder cancer. News release. Pfizer. April 26, 2025. Accessed April 26, 2025. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-sasanlimab-combination-significantly-improves-event

The phase 3 CREST study demonstrated that sasanlimab combined with BCG significantly prolongs event-free survival (EFS) compared to BCG alone in patients with high-risk non-muscle invasive bladder cancer (NMIBC). The study involved 1055 BCG-naïve patients, with a primary focus on EFS between treatment arms. Results showed a 32% lower risk of EFS events in the combination arm. Complete response rates in patients with carcinoma in situ (CIS) were notably higher with the combination therapy. The safety profile was consistent with known data, and quality of life was maintained.

“In the patients with CIS, the probability of a continued complete response at 36 months was 92% vs 67.7%," said Neal D. Shore, MD, FACS. 

CREST: Significant EFS boost seen with sasanlimab plus BCG in NMIBC

 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.

“The increased use of combination therapy over time is expected, as implementation of novel therapies typically occurs over several years,” the authors noted. “To our knowledge, there is no large randomized clinical trial of [androgen receptor pathway inhibitors] (ARPIs) vs docetaxel doublet combinations in mHSPC, and it is unlikely that such a trial of 2 drug combinations will be performed with OS as the primary end point.”

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).

“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,” the authors concluded.

They also noted, “Future research into the role of docetaxel in triple combination is needed to elucidate the benefit of chemotherapy in mHSPC.”

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.

Combination therapy linked to longer OS vs ADT in veterans with mHSPC

The Ibex Prostate AI-powered solution demonstrated the ability to accurately identify and grade prostate cancer in the primary diagnosis of prostate needle biopsy (PNB) specimens, according to data presented at the United States and Canadian Academy of Pathology (USCAP) annual meeting in Baltimore, Maryland.

The study was conducted through a collaboration between Ibex Medical Analytics and the University of Pittsburgh Medical Center in Pennsylvania.

In addition to Ibex Prostate, Ibex Medical Analytics offers 2 other AI-based solutions with indications in breast cancer and gastric cancer. Data on those tools were also presented at the USCAP meeting.

"[Ibex] offers an unparalleled breadth of detection capabilities going well beyond cancer and becoming an integral part of everyday clinical practice in laboratories, hospitals, and health systems globally. With these outstanding outcomes achieved in leading US health care institutions across various tissue types, amplified by very positive user feedback, our technology continues to set the standard for AI solutions in pathology, helping clinicians improve patient outcomes,” said Chaim Linhart, PhD, in a news release on the data.

 Linhart is the chief technology officer and co-founder of Ibex Medical Analytics.

Overall, data from the Ibex Prostate study showed that in pre-classifying parts with the likelihood to be benign or malignant, Ibex Prostate demonstrated an area under the curve of 0.994 (95% CI, 0.99-0.998), a negative predictive value of 97.5% (95% CI, 95.1%-98.9%), and a positive predictive value of 99.2% (95% CI, 97.8%-99.8%). In total, the AI solution marked 17.9% of parts as suspicious (medium likelihood), with 78% of those being classified as benign and 22% as malignant per the pathologist.

Further, agreement between the AI tool and the pathologists in regard to Gleason group (GG) grading was high at 90% (defined as a complete agreement or a difference of 1 GG).

The user feedback from pathologists was also positive, with a satisfaction mark of 95% in regard to Gleason scoring, 90% in perineural invasion detection, and 95% in tissue and tumor length automated measurements. Overall, participating pathologists felt that there is potential to increase diagnostic efficiency by using the AI-powered tool in a clinical setting.

In total, the investigators in the study assessed 206 cases, which were composed of 860 parts and 1159 hematoxylin and eosin (H&E)-stained slides. The H&E-stained slides were scanned at 40x magnification. PNB specimens were collected from October 2022 to February 2023 and selected at random for AI analysis and subsequent review by genitourinary (GU) pathologists.

The AI solution was used for the prospective primary diagnosis of PNBs by 4 trained GU pathologists. The slides were also reviewed by pathologists via microscopic examination. Final diagnoses were either categorized as malignant, atypical small acinar proliferation, or benign.

The investigators concluded, “We report the successful implementation of a multi-feature AI solution that automatically imparts clinically relevant diagnostic parameters regarding prostate cancer, grading, measurements, and other pathologic features. The solution demonstrated its capability to accurately detect cancer and contribute to diagnostic quality and can serve as a valuable tool for pathologists in clinical decision-making in routine pathology practice.”

1. Korentzelos D, Deebajah MM, Quiroga-Garza GM, et al. Routine use of an artificial intelligence solution for primary diagnosis of prostate biopsies in clinical practice. Presented at: United States and Canadian Academy of Pathology Annual Meeting. March 23-28, 2024. Baltimore, Maryland. Poster 110

2. Ibex presents new data from multiple studies showcasing accuracy of AI in prostate, breast and gastric cancer diagnosis. News release. Ibex Medical Analytics. March 21, 2024. Accessed March 26, 2024. https://www.prnewswire.com/news-releases/ibex-presents-new-data-from-multiple-studies-showcasing-accuracy-of-ai-in-prostate-breast-and-gastric-cancer-diagnosis-302095787.html

Ibex Prostate, an AI-powered solution, demonstrated high accuracy in identifying and grading prostate cancer in needle biopsy specimens, as presented at the USCAP annual meeting. The study, conducted with the University of Pittsburgh Medical Center, showed an area under the curve of 0.994, with high predictive values. The AI tool achieved a 90% agreement with pathologists on Gleason grading. User feedback was positive, indicating potential for increased diagnostic efficiency. The study assessed 206 cases, highlighting the AI's capability to enhance diagnostic quality in routine pathology practice.

Overall, participating pathologists felt that there is potential to increase diagnostic efficiency by using Ibex Prostate in a clinical setting. 

Ibex Prostate demonstrates diagnostic value in prostate cancer

How common is a diagnosis of de novo metastatic prostate cancer? In an interview with 

, breaks down the answer to this question and more in the wake of former President Joe Biden’s recent cancer diagnosis.

According to Weiner, while it’s uncommon for men in the US to be diagnosed at this late stage of disease, it can happen in those who have stopped screening.

He explained, “For someone who is the former president's age range, he would certainly be above the typical age range that we might recommend screening, and certainly might be above the age range where we would say someone who was screening might want to consider stopping screening. While it's not common this day and age in the US to be diagnosed with metastatic prostate cancer, it still does happen.”
Weiner is a urologist at Cedars-Sinai Medical Center in Los Angeles, California.

Adam B. Weiner, MD, discusses prognosis and treatment options for men with metastatic prostate cancer in light of President Biden's recent cancer diagnosis.

De novo metastatic prostate cancer: Understanding Biden’s prognosis and treatment

Weiner also added, “President Biden was diagnosed with de novo metastatic prostate cancer. There are a number of great options for him at this point in terms of treatment.”

Depending on a number of factors, overall survival for patients in this disease state ranges from 5 to 10 years, according to Weiner. Ultimately, though, the decision for what treatment to pursue will be made with a few considerations in mind, including the disease volume, other medical issues, and more.

1. Biden diagnosed with ‘aggressive form’ of prostate cancer. CNN. May 19, 2025. Accessed May 22, 2025. https://edition.cnn.com/2025/05/18/politics/joe-biden-prostate-cancer

A prostate cancer expert breaks down likelihood of a diagnosis of metastatic prostate cancer and touches on available treatment options.  

Madison M. Wahlen

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