Experts Recount the Most Notable Data From the 2026 Genitourinary Cancers Symposium

During the 2026 Genitourinary Cancers Symposium (ASCO GU), which was held from February 26 through 28, 2026, in San Francisco, California, experts in genitourinary cancer care from across the world convened to share new data in renal cell carcinoma (RCC), urothelial carcinoma, and prostate cancer. Notable presentations included data from the first interim analysis of the phase 3 LITESPARK-022 trial (NCT05239728), results from the final analysis of the SunRISE-2 study (NCT04658862), findings from the phase 3 KEYNOTE-B15/EV-304 trial (NCT04700124) and final data from the phase 3 EORTC 1333/PEACE-3 trial (NCT02194842).

OncLive® spoke with the following experts on-site during the meeting to get their perspective on some of the most notable news that were presented during it:

• Toni K. Choueiri, MD, the director of the Lank Center for Genitourinary Oncology and the medical director of International Strategic Initiatives at Dana-Farber Cancer Institute, as well as the Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School, both in Boston, Massachusetts.
• Chandler H. Park, MD, FACP, a medical oncologist at Norton Cancer Institute in Louisville, Kentucky.
• Andrea Necchi, MD, associate professor of oncology at Vita-Salute San Raffaele University and director of Genitourinary Medical Oncology at IRCCS San Raffaele Hospital in Milan, Italy.
• Matthew D. Galsky, MD, the deputy director and director of genitourinary medical oncology; codirector of the Center of Excellence for Bladder Cancer; and a professor of medicine, hematology and medical oncology, and urology, at the Mount Sinai Tisch Cancer Center, in New York, New York.
• Enrique Gallardo, MD, a consultant oncologist at Parc Taulí Hospital Universitari in Sabadell, Spain.

How could LITESPARK-022 data reshape the adjuvant treatment landscape of ccRCC?

Choueiri: [LITESPARK-022] was the first trial to build on adjuvant pembrolizumab [Keytruda] in [this [patient population]. We're pushing the envelope [and] more patients are going to be around for the next generation of drugs. [We are] quite happy with these data and I'm sure this is not the end. There will be more data coming out of LITESPARK-022.

Oncologists should familiarize themselves with belzutifan [Welireg], because it's going to be part of the treatment armamentarium in most of lines of therapy, even in the adjuvant setting. The 2 things to remember are [the risks of] anemia and hypoxia. [Oncologists should also] be familiar with dose reduction…dose interruption, and, most importantly, erythropoiesis-stimulating agentuse, as well as blood transfusion if needed.

Park: LITESPARK-022 [was] a highlight of not only the RCC session but of ASCO GU as a whole.

Findings from LITESPARK-022 supported the February 2026 supplemental new drug applications (sNDAs) seeking the approval of the HIF-2α inhibitor belzutifan (Welireg) in combination with pembrolizumab or berahyaluronidase alfa-pmph (Keytruda Qlex) for the adjuvant treatment of adult patients with renal cell carcinoma (RCC) with a with a clear cell component at an increased risk of recurrence following nephrectomy.^1,2 These sNDAs are under priority review by the FDA.

What did the data from the final analysis of SunRISE-2 show?

Necchi: [SunRISE-2] did not meet its primary end point of improving bladder-intact event-free survival [BI-EFS] [with the gemcitabine intravesical system (Gem-iDRS; Inlexzo; previously TAR-200) plus cetrelimab (JNJ-63723283)]. In both arms, the estimates with chemoradiotherapy and experimental therapy at 1 year were particularly promising and higher than expected.³ Chemoradiotherapy [performed better than] we expected when the study was initially conceived. [However], Gem-iDRS and cetrelimab provided complete response [CR] and BI-EFS outcomes that were still compelling and warrant further investigation in [patients with muscle-invasive bladder cancer (MIBC) not receiving radical cystectomy].

How could KEYNOTE-B15 data affect the perioperative landscape of MIBC?

Galsky: [Results from KEYNOTE-B15] showed remarkable consistency with [those from the phase 3] KEYNOTE-905 study [NCT03924895], particularly [in terms of] the pathological CR rate end point.⁴ [We now have] 2 phase 3 studies showing pretty consistent findings, highlighting both the reproducibility and generalizability of results that we've seen with enfortumab vedotin-ejfv [Padcev] plus pembrolizumab across all clinical disease states so far, both in the metastatic and the muscle-invasive settings. I believe [this combination] represents a standard treatment option for patients with MIBC, now regardless of cisplatin eligibility.

What were the key findings from the PEACE-3 study in mCRPC?

Gallardo: Enzalutamide [Xtandi] plus radium-223 [Xofigo] demonstrated an overall survival [OS] benefit in [patients with] metastatic castration-resistant prostate cancer. The HR [for OS] was 0.76 [one-sided P = .0096], the confidence interval was below 1 in the upper limit and the significance threshold was reached. It’s important to remark that the longer the follow-up, the better the benefit was in terms of OS.

References

1. Keytruda® (pembrolizumab) plus Welireg® (belzutifan) given as adjuvant therapy reduced the risk of disease recurrence or death by 28% compared to Keytruda monotherapy in certain patients with earlier-stage renal cell carcinoma (RCC). News release. Merck. February 28, 2026. Accessed March 3, 2026. https://www.merck.com/news/keytruda-pembrolizumab-plus-welireg-belzutifan-given-as-adjuvant-therapy-reduced-the-risk-of-disease-recurrence-or-death-by-28-compared-to-keytruda-monotherapy-in-certain-patients-with/
2. Choueiri TK, Motzer RJ, Karam JA, et al. Adjuvant pembrolizumab plus belzutifan versus pembrolizumab for clear cell renal cell carcinoma (ccRCC): the randomized phase 3 LITESPARK-022 study. J Clin Oncol. 2026;44(suppl 7):LBA418. doi:10.1200/JCO.2026.44.7_suppl.LBA418
3. Necchi A, Williams SB, Tran P, et al. Gemcitabine intravesical system (Gem-iDRS) in combination with cetrelimab (CET) versus chemoradiotherapy (CRT) in muscle-invasive bladder cancer (MIBC): SunRISe-2 final results. J Clin Oncol. 2026;44(suppl 7):635. doi:10.1200/JCO.2026.44.7_suppl.635
4. 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
5. Gallardo E, Gillessen S, Choudhury A, 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