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European Society for Medical Oncology (ESMO) Congress 2025,

hosts Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, met to discuss the presentations and data sets that may have the biggest impacts across genitourinary (GU) cancer care. Bupathi is executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers. Garmezy is associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers.

Bupathi and Garmezy outlined the top 5 abstracts from the meeting that have the potential to change or inform clinical practice across different GU malignancies. Notable presentations in bladder cancer, prostate cancer, kidney cancer, and other patient populations included the following:

#5: Phase 3 CAPItello-281 Trial (NCT04493853)

, combining capivasertib (Truqap) with abiraterone acetate, prednisone, and androgen deprivation therapy (ADT) prolonged radiographic progression-free survival (rPFS) among patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (HSPC).

Data revealed a median rPFS of 33.2 months (95% CI, 25.9-44.2) in the capivasertib arm vs 25.7 months (95% CI, 22.0-29.9) in the placebo arm (HR, 0.81; 95% CI, 0.66-0.98; 

#4: Phase 3 RC48-C016 Trial (NCT05302284)

Combining disitamab vedotin (PF-08046051) with toripalimab-tpzi (Loqtorzi) in the frontline setting significantly improved outcomes vs standard chemotherapy among patients with HER2-expressing locally advanced or metastatic urothelial carcinoma, according to data from the 

Per blinded independent review committee (BIRC) assessment, the median PFS was 13.1 months (95% CI, 11.1-16.7) in the disitamab vedotin arm and 6.5 months (95% CI, 5.7-7.4) in the chemotherapy arm (HR, 0.36; 95% CI, 0.28-0.46; 

 <.0001). Additionally, the median overall survival (OS) was 31.5 months (95% CI, 21.7-not evaluable [NE]) vs 16.9 months (95% CI, 14.6-21.7) in each respective arm (HR, 0.54; 95% CI, 0.41-0.73; 

Findings from the RAMPART trial showed that adjuvant therapy with durvalumab (Imfinzi) plus tremelimumab-actl (Imjudo) following renal cell carcinoma (RCC) resection improved disease-free survival (DFS) compared with active monitoring.

The 3-year DFS rates were 81% in the durvalumab/tremelimumab arm vs 73% in the active monitoring arm across the intent-to-treat (ITT) population (HR, 0.65; 95% CI, 0.45-0.93; 

 = .0094). Additional data revealed that the DFS benefit associated with the durvalumab combination may have been driven by outcomes observed in the higher-risk population (HR, 0.52; 95% CI, 0.34-0.80; 

#2: Phase 3 PSMAddition Trial (NCT04720157)

Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) plus ADT and an androgen receptor pathway inhibitor (ARPI) demonstrated statistically significant improvements in rPFS among patients with prostate specific-membrane antigen (PSMA)–positive metastatic HSPC in the 

Data showed improvements with the lutetium Lu 177 vipivotide tetraxetan regimen vs an ARPI plus ADT alone in terms of rPFS (HR, 0.72; 95% CI, 0.58-0.90; 

 = .002) and OS (HR, 0.84; 95% CI, 0.83-1.13; 

#1: Phase 3 KEYNOTE-905/EV-303 Trial (NCT03924895)

 showed improvements in event-free survival (EFS) among patients with muscle-invasive bladder cancer (MIBC) who were not eligible for or refused cisplatin-based chemotherapy following treatment with perioperative enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) with radical cystectomy and standard pelvic lymph node dissection.

 The median EFS was not reached (NR; 95% CI, 37.3-NR) in the enfortumab vedotin arm vs 15.7 months (95% CI, 10.3-20.5) in the control arm, in which patients underwent radical cystectomy and standard pelvic lymph node dissection followed by observation (HR, 0.40; 95% CI, 0.28-0.57; 

Fizazi K, Clarke NW, De Santis M, et al. A phase III study of capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281. Presented at European Society for Medical Oncology (ESMO) Congress 2025; October 17-21, 2025; Berlin, Germany. Abstract 2383O.

Sheng X, Zeng G, Zhang C, et al. Disitamab vedotin (DV) plus toripalimab (T) versus chemotherapy (C) in first-line (1L) locally advanced or metastatic urothelial carcinoma (la/mUC) with HER2-expression. Presented at European Society for Medical Oncology (ESMO) Congress 2025; October 17-21, 2025; Berlin, Germany. Abstract LBA7.

Larkin J, Powles TB, Frangou E, et al. First results from RAMPART: an international phase III randomised-controlled trial of adjuvant durvalumab monotherapy or combined with tremelimumab for resected primary renal cell carcinoma (RCC) led by MRC CTU at UCL. Presented at European Society for Medical Oncology (ESMO) Congress 2025; October 17-21, 2025; Berlin, Germany. Abstract LBA93.

Tagawa ST, Sartor O, Piulats JM, et al. Phase III trial of [177Lu]Lu-PSMA-617 combined with ADT + ARPI in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (PSMAddition). Presented at European Society for Medical Oncology (ESMO) Congress 2025; October 17-21, 2025; Berlin, Germany. Abstract LBA6.

Vulsteke C, Kaimakliotis HZ, Danchaivijitr P, et al. Perioperative enfortumab vedotin plus pembrolizumab in participants with muscle-invasive bladder cancer who are cisplatin-ineligible: phase 3 KEYNOTE-905 study. Presented at European Society for Medical Oncology (ESMO) Congress 2025; October 17-21, 2025; Berlin, Germany. Abstract LBA2.

Experts highlight the top 5 presentations from ESMO 2025 that may have long-term clinical implications for genitourinary cancer management.

What Were The Most Impactful GU Oncology Data From ESMO 2025?

European Society for Medical Oncology Congress (ESMO) 2025,

hosts Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, convened to discuss the late-breaking abstracts and presentations in genitourinary cancer management they anticipated the most. Bupathi is executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers. Garmezy is associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers.

The hosts reviewed upcoming trial data that may shift therapeutic standards across bladder cancer, prostate cancer, kidney cancer, and other genitourinary malignancy populations. Presentations of interest included those on the following studies:

Investigators assessed whether the addition of lutetium Lu 177 vipivotide tetraxetan (Pluvicto) to androgen deprivation (ADT) and androgen receptor pathway inhibitors (ARPIs) could improve radiographic progression-free survival (rPFS) vs standard of care alone in patients with metastatic hormone-sensitive prostate cancer.

Prior topline data showed a significant rPFS improvement in the lutetium Lu 177 arm.

Findings may support moving radioligand therapy to an earlier prostate cancer treatment setting.

Phase 3 KEYNOTE-905/EV-303 trial (NCT03924895)

Patients with muscle-invasive bladder cancer who were ineligible for cisplatin were assigned to receive surgery plus perioperative pembrolizumab (Keytruda) and enfortumab vedotin-ejfv (Padcev) or surgery alone.

, statistically significant and clinically meaningful rPFS and overall survival (OS) improvements occurred in the enfortumab vedotin plus pembrolizumab arm.

Data may pose questions about the future role that chemotherapy may play in the perioperative space among patients with MIBC.

Investigators evaluated durvalumab (Imfinzi) with or without tremelimumab-actl (Imjudo) among patients with resected primary renal cell carcinoma.

If the data are positive, trials like RAMPART may clarify the role that immunotherapy can play in the perioperative treatment setting.

An international prospective open-label, randomized, phase III study comparing 177Lu-PSMA-617 in combination with SoC, versus SoC alone, in adult male patients with mHSPC (PSMAddition). ClinicalTrials.gov. Updated September 23, 2025. Accessed October 15, 2025. https://tinyurl.com/ycbktner

Novartis Pluvicto™ demonstrates statistically significant and clinically meaningful rPFS benefit in patients with PSMA-positive metastatic hormone-sensitive prostate cancer. News release. Novartis. June 2, 2025. Accessed October 14, 2025. https://tinyurl.com/fedzdhfx

Perioperative pembrolizumab (MK-3475) plus cystectomy or perioperative pembrolizumab plus enfortumab vedotin plus cystectomy versus cystectomy alone in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MK-3475-905/​KEYNOTE-905/​EV-303). ClinicalTrials.gov. Updated August 28, 2025. Accessed October 15, 2025. https://tinyurl.com/5ddk6hrw

PADCEV plus KEYTRUDA significantly improves survival for certain patients with bladder cancer when given before and after surgery. News release. Pfizer and Astellas Pharma. August 12, 2025. Accessed October 15, 2025. https://tinyurl.com/mtnvfvv2

Renal Adjuvant MultiPle Arm Randomised Trial (RAMPART). ClinicalTrials.gov. Updated September 7, 2020. Accessed October 15, 2025. https://tinyurl.com/26w8whuk

European Society for Medical Oncology Congress (ESMO)

Experts highlight anticipated sessions at the 2025 ESMO Congress, including those on the PSMAddition and EV-303 trials. 

Exploring the ESMO 2025 Presentations That May Shift GU Oncology

FDA approval of the gemcitabine intravesical system

 (Inlexzo; formerly TAR-200) for patients with high-risk, Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle-invasive bladder cancer (NMIBC), Gary Steinberg, MD, discussed how this regulatory decision may impact the treatment paradigm.

Steinberg, a professor in the Department of Urology at Rush University, highlighted an unmet need for those with BCG-unresponsive, high-grade NMIBC. With a different mechanism of action compared with prior therapeutic choices in the field, he stated that the gemcitabine intravesical system may allow patients and physicians to benefit tremendously. Based on supporting data from the phase 2 SunRISe-1 trial (NCT04640623), he described how the gemcitabine intravesical system may replace prior standards such as intravesical gemcitabine plus docetaxel.

The conversation also touched upon considerations for preventing the risk of progression to metastatic disease with delayed cystectomy, as Steinberg emphasized following up with patients via cystoscopies, urinary cytologies, CT scans, or MRI imaging after treatment with the intravesical system. Steinberg also detailed strategies for mitigating urinary frequency, dysuria, and other toxicities associated with the therapy. He noted a “fine line” regarding bladder medication administration to older patient populations, as these practices may cause adverse effects such as dry mouth, constipation, and blurry vision.

Looking ahead, Steinberg illustrated a need to clarify the immunologic effects of regimens like the gemcitabine intravesical system, which can inform the use of additional therapeutic combinations down the road. He highlighted how other novel agents like cretostimogene grenadenorepvec (CG0070) may further improve outcomes in the NMIBC landscape.

“One of the key questions that we all need to ask with all our treatments is not about the patients who respond, but about the patients who do not respond,” Steingerg stated regarding the potential next steps for research. “We can begin to understand mechanisms of resistance so that we can target those mechanisms of resistance and treat them better.”

U.S. FDA approval of INLEXZO (gemcitabine intravesical system) set to transform how certain bladder cancers are treated. News release. Johnson & Johnson. September 9, 2025. Accessed September 22, 2025. https://tinyurl.com/4zjz22z7

Prospective data observed with the gemcitabine intravesical system may be superior to prior reports of other therapies in BCG-unresponsive NMIBC.

Gemcitabine Intravesical System Offers Tremendous Benefits in NMIBC

hosts Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, discussed the role that circulating tumor DNA (ctDNA) may play in the monitoring and management of genitourinary cancers as well as other disease types with their colleague, Arnab Basu, MBBS, MPH, FACP.

The group began by providing an overview of ctDNA’s importance in the field, with Basu highlighting his initial use of the marker when treating patients with colorectal cancer who were experiencing toxicity in the adjuvant setting. Additionally, Basu distinguished between tumor-informed and tumor-uninformed testing, emphasizing an approach that monitors for actionable genes that can inform targeted decision-making from a therapeutic standpoint. Describing how the chance of a false positive is less than 1%, Basu stated that a positive result in the adjuvant setting almost certainly guarantees the need for therapy.

As part of the discussion, the experts considered the utility of ctDNA based on prior findings from studies like the phase 3 NIAGARA trial (NCT03732677), in which higher ctDNA clearance from baseline to the time before radical cystectomy correlated with an enhanced benefit with the addition of durvalumab (Imfinzi) to neoadjuvant chemotherapy. Regarding the potential next steps in the field, the group spoke about the potential use of urine ctDNA testing in bladder cancer, the possibility of investigating the de-escalation of imaging, and the need for additional cross-comparison data on different mechanisms of ctDNA testing.

Bupathi is executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers. Garmezy is associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers. Basu is the senior associate consultant and a medical oncologist specializing in the care of genitourinary cancers at Mayo Clinic Comprehensive Cance Center.

Powles T, Van Der Heijden MS, Wang Y, et al. Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA. 

2025;43(suppl 16):4503. doi:10.1200/JCO.2025.43.16_suppl.4503

Experts discuss key considerations for applying ctDNA to clinical practice, such as distinguishing between tumor-informed and tumor-uninformed testing.

Diving Into the Practical Applications of ctDNA in Oncology Care

While attending the 2025 World Conference on Genitourinary Cancers (World GU), 

 hosts Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, spoke with various experts and presenters about critical developments that may improve the treatment of patients with different genitourinary malignancies. Bupathi is executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers. Garmezy is associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers.

In this episode, Bupathi and Garmezy explored the conference halls to chat with several colleagues and peers who presented on topics related to the care of those with prostate cancer, kidney cancer, bladder cancer, and other genitourinary malignancies. The hosts exchanged ideas on how to elevate the quality of care for these patients in a community-based setting with the following attendees:

Mehmet Asim Bilen, MD, a professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine and director of the Genitourinary Medical Oncology Program at Winship Cancer Institute of Emory University;

Sid Sadler, a patient advocate and survivor of kidney cancer;

Kerry R. Schaffer, MD, an assistant professor of Medicine in the Division of Hematology and Oncology of the Department of Medicine at Vanderbilt University Medical Center;

Mark T. Fleming, MD, a board-certified medical oncologist at Virginia Oncology Associates;

Jeff Yorio, MD, a medical oncologist who serves as the Central Texas Research Site Leader for Texas Oncology and SCRI;

Mike Lattanzi, MD, a medical oncologist with a focus on genitourinary malignancies at Texas Oncology;

Elizabeth Kessler, MD, an associate professor of Medical Oncology at the University of Colorado;

Benjamin L. Maughan, MD, PharmD, an associate professor in the Division of Medical Oncology at Huntsman Cancer Institute;

and Alan Tan, MD, a genitourinary oncology and melanoma specialist at Vanderbilt-Ingram Cancer Center as well as an assistant professor of Medicine in the Division of Hematology and Oncology at Vanderbilt University Medical Center.

Panelists and presenters attending World GU 2025 shared their perspectives on optimizing the management of prostate, kidney, and bladder cancers.

Episode 14: Multidisciplinary Care Insights Across World GU 2025

 hosts Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, traveled to the 2025 World Conference on Genitourinary Cancers (World GU) to speak with different experts about important advances and key takeaways related to the care of patients with genitourinary malignancies. Bupathi is executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers. Garmezy is associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers.

In this episode, Bupathi and Garmezy sat down with Sam S. Chang MD, MBA, and Jeff Yorio, MD, to exchange knowledge on elevating the efficacy of multidisciplinary care for patients with prostate cancer, kidney cancer, and bladder cancer in a community-based setting. Chang is the chief surgical officer and the Urologic Oncology division chief at the Vanderbilt Ingram Cancer Center. Yorio is a medical oncologist who serves as the Central Texas Research Site Leader for Texas Oncology and SCRI.

The conversation partly focused on overcoming challenges associated with prostate cancer management in a community practice. Chang highlighted strategies for risk stratifying disease based on previously published guidelines, noting the importance of surveillance depending on a patient’s observed degree of risk. Additionally, the experts discussed how factors such as Decipher® Prostate scores, MRI scans, and prostate-specific antigen (PSA) levels may factor into the decision to surveil patients with prostate cancer.

Regarding kidney cancer, the group spoke about strategies for deciding between monitoring patients or expediting intervention with modalities like nephrectomy or cryoablation. An observed mass of less than 2 cm, for example, represented a situation where surveillance could be optimal. The experts also detailed appropriate circumstances for offering immunotherapy and tyrosine kinase inhibitor (TKI)–based regimens upfront prior to surgery.

As part of the discussion on bladder cancer management, the group emphasized improving systemic therapies and locally assessing the bladder more efficiently. Additionally, with a newfound “embarrassment of riches and possibilities” regarding the development and approval of novel intravesical therapies, the experts discussed how medical oncologists can best collaborate with urologists to monitor patients undergoing this type of treatment.

A group of community and academic oncologists exchanged ideas on optimizing therapy across different prostate, kidney, and bladder cancer populations.

Elevating Community Oncology Care: Insights From World GU 2025

Episode 13: Perspectives on Optimizing Community Care at World GU 2025

World GU Ep 2

At the 2025 World Conference on Genitourinary Cancers (World GU), 

 hosts Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, spoke with different experts about critical developments in the treatment of those with genitourinary cancers. Bupathi is executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers. Garmezy is associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers.

In this episode, Bupathi and Garmezy met with Sam S. Chang MD, MBA, and Jeff Yorio, MD, to share ideas on improving the efficacy of multidisciplinary care for patients with prostate cancer, kidney cancer, and bladder cancer in a community practices. Chang is the chief surgical officer and the Urologic Oncology division chief at the Vanderbilt Ingram Cancer Center. Yorio is a medical oncologist who serves as the Central Texas Research Site Leader for Texas Oncology and SCRI.

The conversation first touched upon optimizing prostate cancer management in a community-based setting. Chang highlighted strategies for risk stratifying disease based on previously published guidelines, noting how the utility of surveillance may depend on a patient’s observed degree of risk. Additionally, the experts discussed how factors such as Decipher® Prostate scores, MRI scans, and prostate-specific antigen (PSA) levels may influence the decision to surveil patients with prostate cancer.

The group also spoke about strategies for deciding between monitoring patients or expediting intervention with modalities like nephrectomy or cryoablation for those with kidney cancer. An observed mass of less than 2 cm, for example, represented a situation where surveillance could be more preferable. The experts also detailed appropriate conditions for administering immunotherapy and tyrosine kinase inhibitor (TKI)–based regimens upfront prior to surgery.

Regarding bladder cancer management, the group emphasized improving systemic therapies and locally assessing the bladder more efficiently. Additionally, with a newfound “embarrassment of riches and possibilities” related to the development and approval of novel intravesical therapies, the experts discussed how medical oncologists can effectively collaborate with urologists to monitor patients undergoing this type of treatment.

Experts discuss considerations for improving the care of patients with prostate, kidney, and bladder cancer in community-based practices at World GU 2025.

Episode 13: Perspectives on Optimizing Community Care at World GU 2025  

hosts Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, traveled to the 2025 World Conference on Genitourinary Cancers (World GU) to speak with various experts about key advances in genitourinary oncology. As part of one discussion, Bupathi and Garmezy sat down with Bradley G. Somer, MD, to exchange ideas about the management of genitourinary cancers harboring variant histologies, which included such populations as those with prostate cancer, bladder cancer, and kidney cancer.

Regarding prostate cancer, the group highlighted potential treatment strategies for patient subgroups such as those with small cell histology or neuroendocrine differentiation. The discussion explored how modalities such as androgen deprivation therapy, chemotherapy, and radiation may factor into the care of patients with prostate cancer harboring variant histologies, especially in the context of a community oncology setting.

Next, the conversation focused on methods for managing papillary, plasmacytoid, small cell, and other disease variants in the context of bladder cancer. Based on previously published data and prior clinical experience, the group discussed the appropriate circumstances for implementing regimens such as enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) or other immunotherapy approaches depending on how a patient presents with bladder cancer.

Additionally, the group reviewed strategies for managing clear cell, papillary, and chromophobe variants in kidney cancer along with other disease histologies. The experts considered key factors for deciding on when to administer VEGF inhibitors and other tyrosine kinase inhibitor combinations based on the observed histology.

Bupathi is executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers. Garmezy is associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers. Somer is a medical oncologist, senior partner on the Executive Cancer Council, and president at West Cancer Center & Research Institute.

At World GU 2025, experts discussed forming treatment strategies for patients with variant histologies across prostate, bladder, and kidney cancer.   

Optimizing Care Planning for Variant Histology Populations at World GU 2025

, hosts Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, spoke with Nabil Adra, MD, about testicular cancer care. The discussion gave a comprehensive overview of managing germ cell tumors, offering practical pearls for community oncologists.

Discover key takeaways on tumor markers, the BEP vs. EP debate, and the role of surgery in stage II testicular cancer. 

Genitourinary Cancers

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