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In the newest episode of Oncology Decoded, hosts Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, spoke about the implementation of artificial intelligence (AI)–based tools and large language models (LLMs) into the study and management of genitourinary malignancies. Leveraging his background in biomedical informatics, Bupathi broke down the specific tools that can assist with documentation, digital pathology, real-time diagnostics, and other relevant clinical applications. The conversation helped differentiate between modalities like LLMs, which assist with documentation, chart summarization, and clinical trial matching, and multimodal AI, a tool that involves combining genomics, laboratory values, and other data to generate patient-level insights. Given the growing prevalence of LLMs like ChatGPT and Claude for resolving menial tasks, Bupathi emphasized that these platforms will not replace physicians who can share human oversight and expertise with patients. In the realm of digital pathology, the hosts discussed how AI tools like ArteraAI can help collect tumor grades and prognostic information from Hematoxylin and Eosin slides and potentially mitigate the subjectivity of Gleason scores through consistent patterns that humans may misinterpret over time. Additionally, Bupathi described how AI can remove subjectivity from imaging by generating mathematical calculations for standardized uptake value metrics on PET scans in place of visual estimation. Regarding the future of the field, the hosts envisioned a type of AI tool that may synthesize years of patient data into a concise synopsis, which may help treat patients with complex histologies like castration-resistant disease. Overall, they predicted a shift in which specialized AI agents could communicate with one another to present synthesized data and recommendations to human clinicians. Bupathi and Garmezy are executive cochairs of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI). Additionally, Bupathi is the president and a medical oncologist with Rocky Mountain Cancer Centers, specializing in solid tumors and genitourinary cancers. Garmezy is the associate director of genitourinary research for SCRI and a medical oncologist at SCRI Oncology Partners, specializing in genitourinary cancers.

In this episode of Oncology Decoded, hosts Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, discussed treatment for urothelial carcinoma following updates from the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. With enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) now the frontline standard, the hosts focused on emerging biomarker-driven strategies that show efficacy after progression on first-line care. Bupathi outlined the current algorithm, with platinum-based chemotherapy—typically gemcitabine plus carboplatin—representing the most common second-line option. Beyond chemotherapy, sacituzumab govitecan-hziy (Trodelvy) retained its NCCN category 2 recommendation despite losing its FDA accelerated approval in urothelial carcinoma after the confirmatory phase 3 TROPiCS-04 trial (NCT04527991) did not yield an overall survival benefit. For biomarker-selected patients, erdafitinib (Balversa) is available for FGFR3-altered disease, and fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) is FDA-approved for HER2 immunohistochemistry (IHC) 3+ solid tumors, including bladder cancer. Garmezy, an investigator on the phase 1 NEXUS-01 trial (NCT06465069), discussed data on LY4052031, a nectin-4-directed antibody drug conjugate (ADC) carrying a topoisomerase payload, in patients previously treated with enfortumab vedotin, which also targets nectin-4 but delivers a different payload class. The trial showed response rates of 30% to 40% in that population, with some durable responses, suggesting resistance to enfortumab vedotin often reflects payload-specific resistance rather than loss of nectin-4 expression. Garmezy described the data as hypothesis-generating. Regarding patients who progress on frontline enfortumab vedotin plus pembrolizumab, the hosts said they would prioritize a biomarker-directed option, such as erdafitinib for FGFR3 alterations or T-DXd for HER2 expression, when a trial is not available, while reserving chemotherapy for later lines. Given the lack of comparative data to help guide a choice between erdafitinib and T-DXd when a patient has both an FGFR3 alteration and HER2 expression, the hosts noted that selections come down to shared decision-making around toxicity profile and route of administration. Bupathi and Garmezy are executive cochairs of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI). Additionally, Bupathi is the president and a medical oncologist with Rocky Mountain Cancer Centers, specializing in solid tumors and genitourinary cancers. Garmezy is the associate director of genitourinary research for SCRI and a medical oncologist at SCRI Oncology Partners, specializing in genitourinary cancers.  References Gilead provides update on US indication for Trodelvy in metastatic urothelial cancer. News release. Gilead Sciences, Inc. October 18, 2024. Accessed July 14, 2026. https://tinyurl.com/hyk3fhmf FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma. News release. FDA. January 19, 2024. Accessed July 14, 2026. https://tinyurl.com/bddc5zz9 FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors. News release. FDA. April 5, 2024. Accessed July 14, 2026. https://tinyurl.com/567c9akx Iyer G, Gao X, Wei AZ, et al. Initial results from NEXUS-01, a phase 1 study of LY4052031, an antibody-drug conjugate targeting Nectin-4, in participants with advanced or metastatic urothelial carcinoma. J Clin Oncol. 2026;44(16 suppl):4508. doi:10.1200/JCO.2026.44.16_suppl.4508

In the newest episode of Oncology Decoded, hosts Manojkumar Bupathi, MD, MS; and Benjamin Garmezy, MD, discussed takeaways from the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting that may guide clinical practice. Following their initial conversation on the most critical presentations in prostate cancer, Bupathi and Garmezy spoke about additional presentations that may influence decision-making in the clinic for patients with bladder cancer and kidney cancer. Bupathi and Garmezy are executive cochairs of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI). Additionally, Bupathi is president and medical oncologist with Rocky Mountain Cancer Centers, specializing in solid tumors and genitourinary cancers. Garmezy is the associate director of genitourinary research for SCRI and a medical oncologist at SCRI Oncology Partners, specializing in genitourinary cancers. They discussed the following presentations: EV-302Long-term data from the phase 3 EV-302/KEYNOTE-A39 trial (NCT04223856) showed that enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) demonstrated a sustained overall survival (OS) benefit compared with platinum-based chemotherapy in the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma. With a median follow-up of 42.8 months, the median OS was 33.6 months (95% CI, 26.6-39.8) in the enfortumab vedotin arm vs 15.9 months (95% CI, 13.6-18.3) in the chemotherapy arm (HR, 0.53; 95% CI, 0.45-0.63). Additionally, the objective response rate (ORR) was 67.5% vs 44.2% in each respective arm. Overall, the long-term data reinforced enfortumab vedotin plus pembrolizumab as a frontline standard of care for patients with locally advanced or metastatic urothelial carcinoma. RAMPARTIn the phase 3 RAMPART trial (NCT03288532), combining durvalumab (Imfinzi) with tremelimumab-actl (Imjudo) showed a statistically significant improvement in disease-free survival (DFS) vs active monitoring among patients with resected primary renal cell carcinoma, although no significant improvement was observed with durvalumab monotherapy. According to the hosts, these findings may introduce some uncertainty surrounding the increased uptake of PD-L1 inhibitors in this patient population. Data showed that durvalumab monotherapy reduced the risk of disease recurrence or death by 26%, although this improvement did not cross the prespecified threshold for statistical significance (HR, 0.74; 95% CI, 0.53-1.04; 1-sided P = .041). The 3-year DFS rates were 78% with durvalumab alone vs 72% with active monitoring. References Powles TB, van der Heijden MS, Bedke J, et al. Enfortumab vedotin plus pembrolizumab vs chemotherapy for previously untreated locally advanced or metastatic urothelial carcinoma: 3.5-year follow-up and response analyses from the phase 3 EV-302 study. J Clin Oncol. 2026;44(suppl 16):4507. doi:10.1200/JCO.2026.44.16_suppl.4507 Larkin JM, Powles T, Frangou E, et al. Durvalumab monotherapy versus active monitoring for resected primary renal cell carcinoma in RAMPART: an international, phase 3, randomized controlled trial. J Clin Oncol. 2026;44(suppl 17):LBA4511. doi:10.1200/JCO.2026.44.17_suppl.LBA4511

In the newest episode of Oncology Decoded, hosts Manojkumar Bupathi, MD, MS; and Benjamin Garmezy, MD, provided a recap of the most critical presentations and data to emerge from the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Specifically, they highlighted the late-breaking abstracts that may transform the standard of care for different prostate cancer populations. Bupathi and Garmezy are executive cochairs of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI). Additionally, Bupathi is president and medical oncologist with Rocky Mountain Cancer Centers, specializing in solid tumors and genitourinary cancers. Garmezy is the associate director of genitourinary research for SCRI and a medical oncologist at SCRI Oncology Partners, specializing in genitourinary cancers. Together, they dissected updated results from the following trials: TALAPRO-3In the phase 3 TALAPRO-3 trial (NCT04821622), combining talazoparib (Talzenna) with enzalutamide (Xtandi) significantly improved radiographic progression-free survival (rPFS) vs standard enzalutamide monotherapy among patients with metastatic castration-sensitive prostate cancer (CSPC) harboring homologous recombination repair (HRR) alterations. Based on investigator assessment, the median rPFS was not reached (NR; 95% CI, NR-NR) with the talazoparib combination vs 45.8 months (95% CI, 37.7-NR) with enzalutamide plus placebo (HR, 0.481; 95% CI, 0.357-0.647; P .0001). Overall, the data supported talazoparib plus enzalutamide as a potential treatment option for patients with HRR-altered metastatic CSPC and highlighted the importance of early molecular testing in prostate cancer. PROTEUSFindings from the phase 3 PROTEUS trial (NCT03767244) demonstrated a reduced risk of death or metastasis with apalutamide (Erleada) plus androgen deprivation therapy (ADT) vs placebo plus ADT among patients with high-risk localized or locally advanced prostate cancer. With a median follow-up of 61.7 months, 8.9% of patients in the apalutamide group experienced a pathological complete response (pCR) vs 1% of those who received placebo (OR, 10.17; 95% CI, 5.27-19.64; P .001). The likelihood of metastasis-free survival at 5 years was 78.2% vs 73.5% in each respective arm (HR, 0.80; 95% CI, 0.67-0.96; P = .02). According to the study investigators, results from PROTEUS may support apalutamide plus ADT and radical prostatectomy as a new standard of care for patient with high-risk localized or locally advanced disease. References Agarwal N, Matsubara N, Azad A, et al. TALAPRO-3: Talazoparib (TALA) + enzalutamide (ENZA) compared with placebo (PBO) + ENZA for the treatment of patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) harboring homologous recombination repair (HRR) gene alterations. J Clin Oncol. 2026;44(suppl 17):LBA5007. doi:10.1200/JCO.2026.44.17_suppl.LBA5007 Taplin ME, Gleave M, Shore N, et al. Perioperative (neoadjuvant and adjuvant) apalutamide (APA) + androgen deprivation therapy (ADT) vs placebo (PBO) + ADT with radical prostatectomy (RP) in high-risk localized or locally advanced prostate cancer (HR LPC/LAPC): final analysis of the PROTEUS phase 3 study. J Clin Oncol. 2026;44(suppl 17):LBA1. doi:10.1200/JCO.2026.44.17_suppl.LBA1

In the newest episode of Oncology Decoded, hosts Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, convened with their colleagues Suzanne B. Merrill, MD, FACS, and Mark D. Tyson, II, MD, MPH. They broke down the current treatment paradigm for those with non–muscle-invasive bladder cancer (NMIBC) by discussing how novel therapeutic modalities, patient selection criteria, and other practical considerations fit into effective clinical strategies.  The discussion began with an overview of the effectiveness and limitations associated with Bacillus Calmette-Guérin (BCG), and how clinical trials like the phase 3 KEYNOTE-676 (NCT03711032) and phase 3 POTOMAC (NCT03528694) studies may support novel treatment regimens that incorporate checkpoint inhibitors. The group discussed how immunotherapy agents like pembrolizumab (Keytruda) may play important roles in the treatment of patients with NMIBC, especially in the event of BCG-unresponsive disease or BCG shortages.  Additionally, the experts spoke about forming effective collaborations between urologists and medical oncologists to optimally care for patients. Specifically, Merrill emphasized a dedicated team approach to check symptoms, process referrals, and handle other tasks when treating patients who are receiving immune checkpoint inhibitors for their diseases. The conversation concluded with the group emphasizing the development of novel treatment delivery systems across the NMIBC space, which may improve outcomes and positively impact patients from a quality-of-life perspective. Drs. Bupathi and Garmezy are executive cochairs of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI). Additionally, Dr. Bupathi is president and a medical oncologist with Rocky Mountain Cancer Centers, specializing in solid tumors and genitourinary cancers. Dr. Garmezy is the associate director of genitourinary research for SCRI and a medical oncologist at SCRI Oncology Partners, specializing in genitourinary cancers. Merill is a board-certified urologic surgeon at Colorado Urology. Tyson is a urologic oncologist with a subspecialty interest in bladder cancer at Mayo Clinic in Arizona.

In the latest episode of Oncology Decoded, hosts Manojkumar Bupathi, MD, MS; and Benjamin Garmezy, MD, spoke about the clinical utility of enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) for those with muscle-invasive bladder cancer (MIBC) and similar patient populations. They highlighted the “transformational” potential of this therapeutic regimen in the context of findings from the phase 3 KEYNOTE-B15/EV-304 trial (NCT04700124) that investigators presented at the 2026 ASCO Genitourinary Cancers Symposium.Although certain data from the EV-304 trial, including the improvements in pathologic complete responses (pCRs) with the enfortumab vedotin combination over gemcitabine/cisplatin, represent “historical gamechangers”, the hosts pointed towards some uncertainty related to outcomes for those with varying or mixed histologies. According to Bupathi, it may still make sense to administer chemotherapy with immunotherapy in some of these subgroups.  The hosts also considered how many cycles of enfortumab vedotin plus pembrolizumab should be administered across the neoadjuvant and adjuvant settings, noting how markers like circulating tumor DNA may help inform treatment schedules. Additionally, they highlighted a need for additional research to clarify whether cystectomy could be spared for patients receiving this combination regimen while translating the benefits observed in trials like EV-304 to the real world. The discussion also touched upon the treatment of those with metastatic disease, as the hosts considered how dosing cycles, consolidated radiotherapy, and cystectomy with nodal dissection fit into the treatment algorithm for these patients. Garmezy and Bupathi also discussed how the efficacy and safety of the enfortumab vedotin combination compared with gemcitabine plus nivolumab (Opdivo), noting how the EV-304 regimen may be simpler to administer and manage. Bupathi and Garmezy are executive cochairs of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI). Additionally, Bupathi is president of and a medical oncologist with Rocky Mountain Cancer Centers, specializing in solid tumors and genitourinary cancers. Garmezy is the associate director of genitourinary research for SCRI and a medical oncologist at SCRI Oncology Partners, specializing in genitourinary cancers. ReferenceGalsky MD, Valderrama BP, Maruzzo M, et al. Neoadjuvant and adjuvant enfortumab vedotin (EV) plus pembrolizumab (pembro) for participants with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin: Randomized, open-label, phase 3 KEYNOTE-B15 study. J Clin Oncol. 2026;44(suppl 7):LBA630. doi: 10.1200/JCO.2026.44.7_suppl.LBA630

Following the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, Oncology Decoded hosts Manojkumar Bupathi, MD, MS; and Benjamin Garmezy, MD, met to break down the key trials and presentations that may help move the needle in genitourinary oncology. Together, they reviewed findings and clinical implications across various bladder cancer, kidney cancer, and prostate cancer populations. Among several sessions highlighted during their discussion, the experts covered the following presentations: 1.        Phase 3 KEYNOTE-B15 Trial (NCT04700124) a.        Enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) significantly prolonged event-free survival (EFS) outcomes vs gemcitabine plus cisplatin among patients with muscle-invasive bladder cancer (MIBC; HR, 0.53; 95% CI, 0.41-0.70; P .001). b.       The rate of pathological complete response also improved by an estimated difference of 23.4% (95% CI, 16.7%-29.8%; P .001) with the enfortumab vedotin combination. c.        Data from this trial point towards the potential removal of chemotherapy in the perioperative therapy landscape. 2.        Phase 3 LITESPARK-011 Trial (NCT04586231) a.        Belzutifan (Welireg) plus lenvatinib (Lenvima) improved progression-free survival (PFS; HR, 0.70; 95% CI, 0.59-0.84; P = .00007) and responses vs cabozantinib (Cabometyx) monotherapy among those with advanced clear cell renal cell carcinoma. b.       Data showed a median duration of response (DOR) of 23.0 months with the belzutifan combination vs 12.3 months with cabozantinib. c.        Findings may support an eventual FDA approval of belzutifan/lenvatinib in this patient population. 3.        Phase 3 PEACE-3 Trial (NCT02194842) a.        Combining enzalutamide (Xtandi) with radium-223 (Xofigo) boosted overall survival (OS) compared with enzalutamide alone among patients with metastatic castration-resistant prostate cancer (HR, 0.75; 95% CI, 0.60-0.95; P = .0078). b.       Previously reported rPFS improvements with the combination were sustained with longer follow-up, as data showed a median rPFS of 19.2 months vs 16.4 months in the experimental and comparator arms, respectively. Drs. Bupathi and Garmezy are executive cochairs of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI). Additionally, Dr. Bupathi is president and a medical oncologist with Rocky Mountain Cancer Centers, specializing in solid tumors and genitourinary cancers. Dr. Garmezy is the associate director of genitourinary research for SCRI and a medical oncologist at SCRI Oncology Partners, specializing in genitourinary cancers. References Galsky MD, Valderrama BP, Maruzzo M, et al. Neoadjuvant and adjuvant enfortumab vedotin (EV) plus pembrolizumab (pembro) for participants with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin: randomized, open-label, phase 3 KEYNOTE-B15 study. J Clin Oncol. 2026;44(suppl 7):LBA630. doi:10.1200/JCO.2026.44.7_suppl.LBA630 Motzer RJ, Park SH, McDermott RS, et al. Belzutifan (bel) plus lenvatinib (lenva) versus cabozantinib (cabo) for advanced renal cell carcinoma (RCC) after anti-PD-(L)1 therapy: open-label phase 3 LITESPARK-011 study. J Clin Oncol. 2026;44(suppl 7):417. doi:10.1200/JCO.2026.44.7_suppl417 Gallardo E, Tombal BF, Saad F, et al. Final overall survival results from the EORTC 1333/PEACE-3 trial: enzalutamide with or without radium-223 in metastatic castration-resistant prostate cancer. J Clin Oncol. 2026;44(suppl 7):15. doi:10.1200/JCO.2026.44.7_suppl.15

In the latest episode of Oncology Decoded, hosts Manojkumar Bupathi, MD, MS; and Benjamin Garmezy, MD, convened with Meredith Pelster, MD, MSCI; and Jason Henry, MD. Together, they looked back at the presentations and data shared at the 2026 ASCO Gastrointestinal Cancers Symposium that may have long-term impacts on community oncology practice across different gastrointestinal (GI) malignancies, including pancreatic cancer and colorectal cancer (CRC). Trials and sessions of interest included the following: Phase 1 Trial (NCT06179160) of INCB161734 o   INCB161734, an investigational KRAS G12D small molecule inhibitor, displayed a manageable safety profile among patients with advanced or metastatic pancreatic ductal adenocarcinoma. o   The agent produced a disease control rate of 73% (n = 16/22) given at 600 mg once daily and 86% (n = 25/29) when given at 1200 mg once daily. Phase 3 BREAKWATER Trial (NCT04607421) o   Among those with BRAF V600E-mutated metastatic CRC, encorafenib (Braftovi) plus cetuximab (Erbitux) and chemotherapy improved the overall response rate (ORR) at 64.4% vs 39.2% with chemotherapy with or without bevacizumab (Avastin) in the control arm (OR, 2.76; 95% CI, 1.42-5.35; P = .001). o   Overall, the data supported the encorafenib-based combination as a new potential standard of care in BRAF V600E-mutated metastatic CRC. o   The FDA recently granted traditional approval to the encorafenib regimen based on data from the BREAKWATER trial. Phase 3 COMMIT Trial (NCT02997228) o   Chemotherapy in combination with bevacizumab and atezolizumab (Tecentriq) improved outcomes among patients with mismatch repair deficient (dMMR) or microsatellite instability–high (MSI-H) metastatic CRC vs atezolizumab alone. o   Data showed a median progression-free survival (PFS) of 30.0 months vs 4.3 months in the combination and monotherapy arms, respectively. Bupathi is the executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and a medical oncologist with Rocky Mountain Cancer Centers, specializing in solid tumors and genitourinary cancers. Garmezy is the associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and a medical oncologist at SCRI Oncology Partners, specializing in genitourinary cancers. Pelster is associate director of GI Cancer Research at SCRI Oncology Partners and specializes in treating GI cancers as well as head and neck cancers. Henry is associate director of Drug Development at Sarah Cannon. References Wainberg ZA, Henry JT, Park H, et al. Preliminary phase 1 results of INCB161734, a novel oral Kirsten rat sarcoma (KRAS) G12D inhibitor, as monotherapy or in combination with chemotherapy for advanced/metastatic pancreatic duct adenocarcinoma (PDAC). J Clin Oncol. 2026;44(suppl 2):654. doi:10.1200/JCO.2026.44.2_suppl.654 Kopetz S, Wasan HS, Yoshino HS, et al. BREAKWATER: primary analysis of first-line (1L) encorafenib + cetuximab (EC) + FOLFIRI in BRAF V600E-mutant metastatic colorectal cancer (mCRC). J Clin Oncol. 2026;44(suppl 2):13. doi:10.1200/JCO.2026.44.2_suppl.13 FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation. News release. FDA. February 24, 2026. Accessed February 25, 2026. https://tinyurl.com/4xr84a6y Rocha Lima CMS, Yothers G, George TJ, et al. Colorectal Cancer Metastatic dMMR Immunotherapy (COMMIT) study: a randomized phase III study of atezolizumab (atezo) monotherapy versus mFOLFOX6/bevacizumab/atezo (FFX/bev) in the first-line treatment of patients (pts) with deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC)— NRG-GI004/SWOG-S1610. J Clin Oncol. 2026;44(suppl 2):14. doi:10.1200/JCO.2026.44.2_suppl.14

In a special episode of Oncology Decoded, hosts Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, spoke with their colleague Debapriya Mondal, MBBS, MD, DrNB, who connected to the conversation from India. Collectively, the trio reviewed how clinical practice may differ in US- and India-based institutions, specifically as it relates to the treatment of patients with prostate cancer.  According to Mondal, while prostate cancer does not represent one of the top 5 most diagnosed cancer types in India overall, patients appear to present with disease more often in cities like New Delhi, Kolkata, and Bangalore. Additionally, many patients in India appear to be diagnosed with more advanced stages of disease compared with reports in the US.  Regarding medical practices in the US and India, the group discussed potential differences in treatment pathways and specialties that are initially involved in care. Additionally, they highlighted how urologists decide on sequencing androgen deprivation therapy, androgen receptor pathway inhibitors, and other modalities based on region-specific considerations. The conversation also touched upon the costs of various therapies between regions, as Mondal outlined how patients in India may have access to cheaper generic products for reference drugs like olaparib (Lynparza) and rucaparib (Rubraca). Despite other differences in terms of insurance coverage and barriers to treatment access between regions, the group noted certain international similarities in their respective treatment models, including strategies for the management of advanced or localized disease.  Bupathi is the executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and a medical oncologist with Rocky Mountain Cancer Centers, specializing in solid tumors and genitourinary cancers. Garmezy is the associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and a medical oncologist at SCRI Oncology Partners, specializing in genitourinary cancers. Mondal is a consultant medical oncologist from Foris Healthcare in Kolkata, West Bengal, India.

In the latest episode of Oncology Decoded, hosts Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, wound the clock back to 2025 to discuss the key findings and clinical developments that may propel the genitourinary oncology field forward. Following a breakdown of last year’s breakthroughs in kidney cancer and bladder cancer care, the hosts reviewed the biggest headlines and milestones of 2025 related to prostate cancer management and research.  Bupathi is the executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and a medical oncologist with Rocky Mountain Cancer Centers, specializing in solid tumors and genitourinary cancers. Garmezy is the associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and a medical oncologist at SCRI Oncology Partners, specializing in genitourinary cancers. Together, they spoke about several major prostate cancer happenings throughout 2025, including but not limited to: ·      The FDA Approval of the Phase 3 ARANOTE Trial (NCT04736199) Regimeno   In June 2025, the FDA approved darolutamide (Nubeqa) for patients with metastatic castration-sensitive prostate cancer (CSPC) based on findings from the phase 3 ARANOTE trial. o   Topline data showed a median radiographic progression-free survival (rPFS) that was not reached (NR) with darolutamide vs 25 months (95% CI, 19-NR) with placebo (HR, 0.54; 95% CI, 0.41-0.71; P .0001). o   This approval may grant easier access to darolutamide, especially for the treatment of patients who are older or who present with certain neurocognitive disorders. ·      The FDA Approval of the Phase 3 AMPLITUDE Trial (NCT04497844) Regimeno   December 2025 saw the FDA approval of niraparib and abiraterone acetate (Akeega) plus prednisone for adults with suspected or deleterious BRCA2-mutated CSPC. o   Supporting data from the phase 3 AMPLITUDE trial showed a median rPFS that was not estimable (NE; 95% CI, 41 months-NE) in the niraparib arm vs 26 months (95% CI, 18-28) in the placebo arm among 323 patients with BRCA2-mutated disease. o   This approval for patients with BRCA2-mutations reinforces the importance of conducting upfront genetic testing. ·      Phase 3 PSMAddition Trial (NCT04720157)o   Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) plus an androgen receptor pathway inhibitor (ARPI) and androgen deprivation therapy (ADT) significantly prolonged rPFS vs ARPI/ADT treatment alone among patients with prostate specific-membrane antigen (PSMA)–positive metastatic hormone-sensitive prostate cancer (HR, 0.72; 95% CI, 0.58-0.90; P = .002). o   Other data from ESMO Congress 2025 showed that the lutetium Lu 177 combination numerically improved the overall response rate at 85.3% (95% CI, 79.9%-89.6%) vs 80.8% (95% CI, 74.8%-85.8%) in the control arm. o   The safety profile observed in the trial may raise questions over whether it is worthwhile to administer all 6 cycles of lutetium Lu 177 to patients. References FDA approves darolutamide for metastatic castration-sensitive prostate cancer. News release. FDA. June 3, 2025. Accessed January 20, 2026. https://tinyurl.com/yhde24zj FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer. News release. FDA. December 12, 2025. Accessed January 20, 2026. https://tinyurl.com/rcxaj98 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). Ann Oncol. 2025;36(suppl 2):S1627-S1628. doi:10.1016/j.annonc.2025.09.101

As part of ushering in the new year, Oncology Decoded hosts Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, looked back on the most exciting advancements that shook up the genitourinary oncology landscape throughout 2025. Specifically, they highlighted the clinical trial readouts, regulatory milestones, and other breakthroughs that made 2025 a “remarkable year” in kidney cancer and bladder cancer care.Bupathi is the executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and a medical oncologist with Rocky Mountain Cancer Centers, specializing in solid tumors and genitourinary cancers. Garmezy is the associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and a medical oncologist at SCRI Oncology Partners, specializing in genitourinary cancers. Together, they reviewed several key moments in kidney and bladder cancer research, including but not limited to:·      The FDA Approval of The EV-303 Trial (NCT03924895) Regimeno   In November 2025, the FDA approved a neoadjuvant/adjuvant regimen consisting of pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) plus enfortumab vedotin-ejfv (Padcev) for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin.o   “Incredible” data from the phase 3 KEYNOTE-905/EV-303 trial supported the approval, which showed an improvement in event-free survival with the enfortumab vedotin combination vs surgery alone (HR, 0.40; 95% CI, 0.28-0.57; P .0001).o   The approval may lead to a “paradigm shift” in the treatment of this MIBC population. ·      The Phase 3 POTOMAC Trial (NCT03528694)o   Data showed a meaningful disease-free survival (DFS) improvement when adding durvalumab (Imfinzi) to Bacillus Calmette-Guérin (BCG) among patients with BCG-naïve, high-risk NMIBC (HR, 0.68; 95% CI, 0.50-0.93; P = .0154).o   Frontline immunotherapy-based regimens may “complicate” how to think about treating patients with NMIBC later down the line.·      The Phase 3 RAMPART Trial (NCT03288532)o   Adjuvant treatment with durvalumab (Imfinzi) plus tremelimumab-actl (Imjudo) improved DFS compared with active monitoring among patients who underwent resection of primary renal cell carcinoma (RCC; HR, 0.65; 95% CI, 0.45-0.93; P = .0094).o   Following previous unsuccessful trials assessing immunotherapy in adjuvant RCC, the results of RAMPART demonstrate how immunotherapy can work in this space.References FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer. News release. FDA. November 21, 2025. Accessed January 5, 2026. https://tinyurl.com/bdfhmhnk De Santis M, Palou Redorta J, Nishiyama H, et al. Durvalumab in combination with BCG for BCG-naive, high-risk, non-muscle-invasive bladder cancer (POTOMAC): final analysis of a randomised, open-label, phase 3 trial. Lancet. 2025;406(10516):2221-2234. doi:10.1016/S0140-6736(25)01897-5 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. Ann Oncol. 2025;36(suppl 2):S1750. doi:10.1016/j.annonc.2025.09.110

In the latest episode of Oncology Decoded, hosts Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, broke down the treatment decision-making process for patients who present with oligometastatic kidney cancer. The experts zeroed in on this topic following their attendance at the 2025 International Kidney Cancer Symposium (IKCS), which featured a variety of sessions discussing the oligometastatic treatment setting.The conversation opened with an aim to better define what oligometastatic disease constitutes for patients. Bupathi noted how patients can present with synchronous, metachronous, or oligoprogressive cancer based on when metastases appear around the time of diagnosis. Furthermore, the specific nature of a patient’s metastases may influence their treatment course. For example, in the case of a patient with de novo metastatic clear cell disease and lung metastases, Bupathi recommended the use of systemic therapy followed by cytoreduction, and the possibility of nephrectomy plus stereotactic body radiotherapy directed to the metastases.Garmezy also emphasized distinguishing between de novo and recurrent disease, as both types necessitate the development of different treatment goals. For patients with recurrent oligometastatic disease, the primary goal of therapy may entail increasing the cure rate or extending treatment-free survival, depending on individual circumstances. Moreover, specific patient factors may influence the decision on whether to combine immunotherapy with radiotherapy.In terms of standardizing a therapeutic approach for patients who present with oligometastatic disease, the hosts stressed the importance of strengthening efforts across multidisciplinary clinics and collaborating with radiology colleagues to better identify which sites of metastasis are progressing in patients. Bupathi is an executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and a medical oncologist with Rocky Mountain Cancer Centers, specializing in solid tumors and genitourinary cancers. Garmezy is the associate director of genitourinary research, an executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI, and a medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers.

Following the European Society for Medical Oncology (ESMO) Congress 2025, Oncology Decoded 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)In the CAPItello-281 trial, 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).1 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; P = .034).#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 RC48-C016 trial.2 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; P .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; P .0001).#3: Phase 3 RAMPART Trial (NCT03288532)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.3 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; P = .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; P = .0016).#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 PSMAddition trial.4 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; P = .002) and OS (HR, 0.84; 95% CI, 0.83-1.13; P = .125).#1: Phase 3 KEYNOTE-905/EV-303 Trial (NCT03924895)Findings from the KEYNOTE-905/EV-303 trial 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.5 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; P .0001).References 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.

Ahead of the European Society for Medical Oncology Congress (ESMO) 2025, Oncology Decoded 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:- Phase 3 PSMAddition trial (NCT04720157)o 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.o Prior topline data showed a significant rPFS improvement in the lutetium Lu 177 arm.o Findings may support moving radioligand therapy to an earlier prostate cancer treatment setting.- Phase 3 KEYNOTE-905/EV-303 trial (NCT03924895)o 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.o According to previous topline results, statistically significant and clinically meaningful rPFS and overall survival (OS) improvements occurred in the enfortumab vedotin plus pembrolizumab arm.o Data may pose questions about the future role that chemotherapy may play in the perioperative space among patients with MIBC.-  Phase 3 RAMPART trial (NCT03288532)o  Investigators evaluated durvalumab (Imfinzi) with or without tremelimumab-actl (Imjudo) among patients with resected primary renal cell carcinoma.o If the data are positive, trials like RAMPART may clarify the role that immunotherapy can play in the perioperative treatment setting.  References 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

In this episode of Oncology Decoded, 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.ReferencePowles 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. J Clin Oncol. 2025;43(suppl 16):4503. doi:10.1200/JCO.2025.43.16_suppl.4503