News|Articles|February 24, 2026

Experts Preview Practice-Changing Data Ahead of 2026 ASCO GU

Author(s)Ryan Scott
Fact checked by: Alex Biese
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Key Takeaways

  • Perioperative enfortumab vedotin plus pembrolizumab in KEYNOTE-B15/EV-304 met event-free and overall survival end points versus gemcitabine-cisplatin, with tolerability and post-cystectomy feasibility key to adoption.
  • ctDNA-informed adjuvant strategies are advancing, with IMvigor011 using Signatera to trigger atezolizumab upon ctDNA positivity and ongoing analyses needed to define benefiting subgroups.
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Oncologists highlight key 2026 ASCO GU studies in bladder, prostate, kidney and testicular cancers that could reshape treatment and personalize care.

As the cancer community gets ready for the 2026 ASCO Genitourinary (GU) Cancers Symposium, we at CURE are focusing on what the latest research could mean for people living with bladder, prostate, kidney, testicular and other genitourinary cancers. This annual meeting often brings news about new treatments, better ways to use current therapies and ways that may help doctors personalize care.

To help break down what to watch for, we spoke with leading cancer specialists about the studies they are most excited to see and how the results could affect patients now and in the future. We asked them a simple question: Which updates are you most looking forward to, and why do they matter for patients and their families?

Here is what they shared.

Bladder Cancer

Dr. Emre Yekedüz, a medical oncologist at Dana-Farber Cancer Institute, and a faculty member at Ankara University in Türkiye: I am really excited about several studies. First, in bladder cancer, we have the phase 3 KEYNOTE-B15/EV-304, which is evaluating perioperative Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab), an immunotherapy combination, versus standard chemotherapy in muscle-invasive bladder cancer. This study could redefine our curative approach in this setting.

On the other hand, we are also seeing important ctDNA-driven strategies, with data coming from the IMvigor011 trial and additional biomarker work from the NIAGARA trial. These trials move us closer to truly personalized adjuvant therapy in bladder cancer.

Dr. Guru P. Sonpavde, medical director of genitourinary oncology; assistant director of the Clinical Research Unit and Christopher K. Glanz Chair for Bladder Cancer Research at the AdventHealth Cancer Institute: Regarding bladder cancer, I think the number one highlight of the symposium is the phase 3 KEYNOTE-B15/EV-304 clinical trial. This is a phase 3 trial evaluating the combination of Padcev plus Keytruda versus gemcitabine-cisplatin in cisplatin-eligible patients with muscle-invasive bladder cancer. We already know from a press release that this combination was superior to gemcitabine and cisplatin; primary and secondary end points were met for event-free survival and overall survival. The results are eagerly awaited and expected to be practice-changing.

The second trial I want to mention, also in bladder cancer, is an update of sub-analyses from the IMvigor011 trial. This trial examined adjuvant Tecentriq (atezolizumab) in high-risk muscle-invasive bladder cancer, with or without neoadjuvant cisplatin-based chemotherapy, where patients were randomized to Tecentriq or placebo upon conversion to ctDNA positivity using the commercially available Signatera platform.

This study was reported as positive at the 2025 ESMO Congress, where Tecentriq was superior to placebo when patients received it for up to one year post-radical cystectomy. We need to see what further analyses have been done and whether they support specific subgroups potentially benefiting more before we are ready to accept this in the clinic.

Dr. Michael Serzan, medical oncologist, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute; and instructor of medicine, Harvard Medical School: The results of phase 3 KEYNOTE-B15/EV-304 clinical trial are poised to influence the field. This study investigates perioperative Padcev plus Keytruda prior to cystectomy, followed by adjuvant Padcev plus Keytruda versus standard neoadjuvant cisplatin-based therapy.

Last fall at the 2025 ESMO Congress, the combination showed positive results for this combination in cisplatin-ineligible patients. A press release confirmed it met its primary end point of improved overall survival. We are curious to see the tolerability of this regimen in the neoadjuvant space and how well patients handle the combination after surgery.

Prostate Cancer

Yekedüz: Regarding prostate cancer, the EORTC 1333 'PEACE-3' will present final overall survival data at this meeting. We also have other PSMA-targeted strategies that represent major advances in the precision treatment of prostate cancer. Furthermore, biomarker-related trials like CAPItello-281 and the AMPLITUDE trials continue to refine how we use targeted therapies in molecularly selected populations.

Sonpavde: [We are looking forward to] an update of the EORTC 1333 'PEACE-3' trial, which combined Xtandi (enzalutamide) with Xofigo (radium 223) as first-line therapy for metastatic castration-resistant prostate cancer (mCRPC). In [previous] readouts, the combination improved outcomes compared with Xtandi alone. Most of the trial population was not exposed to a previous AR pathway inhibitor in the castration-sensitive space, so the relevance in the current era, where most patients receive an AR pathway inhibitor earlier, is unclear. We know the combination improved both progression-free survival and overall survival, so we will wait to see what new updates come from this specific trial readout.

Kidney (Renal Cell) Cancer

Yekedüz: When it comes to kidney cancer, we have the LITESPARK-022 and LITESPARK-011 trials exploring combinations of Welireg (belzutifan), a HIF-2 alpha inhibitor used in the advanced setting. These trials could potentially expand our treatment options in both the adjuvant and advanced settings of renal cell carcinoma.

Sonpavde: This is the year of Welireg, a HIF-2 alpha inhibitor. Press releases show that two phase 3 trials are already positive for Welireg in clear cell renal cell carcinoma (RCC).

First is the phase 3 LITESPARK-011 trial in the salvage setting for advanced clear cell RCC following PD-1/L1 inhibition. In this trial, Welireg combined with Lenvima (lenvatinib) was superior to Cabometyx (cabozantinib). This trial is potentially practice-changing. The second is the phase 3 LITESPARK-022 trial, which examined Welireg in the adjuvant setting post-surgery for high-risk clear cell RCC, where the combination of Welireg and Keytruda beat Keytruda combined with a placebo.

Dr. Chandler Park, a medical oncologist of Genitourinary Medical Oncology, at the Norton Healthcare Institute, in Louisville, Kentucky: I am very excited about ASCO GU this year, and front and center will be kidney cancer. The LITESPARK-022 study builds on the standard-of-care, which is Keytruda. In this large, randomized phase 3 trial, patients received adjuvant Keytruda versus Keytruda plus Welireg. Welireg is a novel oral medication that lowers the risk of recurrence by decreasing angiogenesis and increasing the intravascular response. A press release has already noted an improvement in disease-free survival. As a physician, I will be looking closely at the side-effect profile, as Welireg can cause anemia and hypoxia. We need to ensure that preventing recurrence does not compromise patient safety.

The second kidney cancer study involving Welireg is LITESPARK-011 in the second-line space. The question is: What happens if first-line treatment fails? LITESPARK-011 is an open-label phase 3 trial for patients who progressed on first-line immunotherapy, comparing Welireg plus Lenvima versus Cabometyx. Press releases show an improvement in progression-free survival, meaning the combination prevents the cancer from progressing for a longer period. However, we must look at the quality of life, including the profile for diarrhea, hypertension, and hand-foot syndrome, to see if this truly becomes the new standard.

The third important study involves SBRT (stereotactic body radiation therapy). I describe SBRT to students like a laser pen – a very narrow, precise scope. Radiation oncologists use this "fine-tooth" technology to target and kill cancer specifically. Data suggests that if you have three to five spots on a scan, you can "zap" those areas to prevent further spread. This year, data on SBRT along with a new marker called KIM-1 (kidney injury molecule 1) will be presented. Similar to how we use PSA for prostate cancer, KIM-1 is emerging as a marker for kidney cancer. The presentation will show circulating KIM-1 levels in patients receiving SBRT, which may reveal whether we can use pinpoint radiation and follow blood concentrations rather than immediately switching systemic treatments.

Serzan: In adjuvant kidney cancer, we have the LITESPARK-022 study. This builds on data supporting the use of Keytruda for patients with high-risk resected clear cell kidney cancer. While we know a year of Keytruda improves disease-free and overall survival, many patients still experience recurrence. LITESPARK-022 randomizes these high-risk patients to either a year of standard-of-care Keytruda or Keytruda plus the HIF-2 alpha inhibitor Welireg. We know from a press release that this is a positive study improving event-free survival, but we are interested in the magnitude of benefit, identifying specific subgroups that benefit most, and observing the side-effect profile of using Welireg earlier in the disease space.

We also have the LITESPARK-011 study for patients with refractory clear cell kidney cancer that has progressed on anti-PD-1 therapy. This trial randomizes patients to either Lenvima plus Welireg or Cabometyx. It is a positive study, but we want to see the real benefit of adding these two together after progression on immunotherapy and how their side effect profiles compare. While VEGF TKIs are the standard for refractory disease, the benefit of this specific combination is very intriguing.

Testicular Cancer

Yekedüz: The CLARITY study is valuable to note in testicular cancer, which is evaluating microRNA as a surveillance biomarker that could dramatically change follow-up for early-stage disease.

Transcript has been edited for clarity and conciseness.

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