Non-Chemo, Biomarker-Driven Perioperative Strategies Highlight Bladder Cancer Presentations to Watch at ASCO GU 2026

With the 2026 Genitourinary (GU) Cancers Symposium just weeks away, OncLive® has asked leading bladder cancer specialists to share the urothelial cancer topics and data they are most eager to follow at this year’s meeting.

We gathered exclusive insights from:

• Jad Chahoud, MD, MPH, chief scientific & innovation officer at Orlando Health Cancer Institute in Florida
• Guru Sonpavde, MD, medical director for GU Oncology, assistant director of the Clinical Research Unit, and the Christopher K. Glanz Chair for Bladder Cancer Research at AdventHealth Cancer Institute in Orlando, Florida
• Axel Merseburger, MD, PhD, professor of urology and head of the Department of Urology at University Hospital Schleswig-Holstein in Germany

Among the most anticipated presentations is the randomized, open-label phase 3 KEYNOTE-B15/EV-304 trial (NCT04700124), which evaluated neoadjuvant and adjuvant enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) vs gemcitabine plus cisplatin in cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC).¹ It was previously announced that this study met its event-free survival (EFS) primary end point.²

Also drawing considerable interest are biomarker-guided approaches using circulating tumor DNA (ctDNA). Exploratory analyses from the phase 3 IMvigor011 trial (NCT04660344) are evaluating tumor-informed ctDNA–guided adjuvant therapy with atezolizumab (Tecentriq) in MIBC.³ Additional attention is focused on urinary tumor DNA (utDNA) and ctDNA analyses from the phase 3 NIAGARA study (NCT03732677), which investigated perioperative durvalumab (Imfinzi) in MIBC.⁴

In the advanced setting, RC48G001 (NCT04879329) is assessing disitamab vedotin (Aidixi) in HER2-expressing, previously treated advanced urothelial carcinoma.⁵

Read more on the most anticipated data expected to read out at ASCO GU 2026.

Neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab for participants with MIBC who are eligible for cisplatin: Randomized, open-label, phase 3 KEYNOTE-B15 study.

Chahoud: In the bladder cancer space, the most awaited study is going to be presented by Matthew Galsky, MD, [of Mount Sinai], looking at neoadjuvant pembrolizumab plus enfortumab vedotin in cisplatin-eligible patients with MIBC, which has the potential to be practice-changing. We know it [met] the [EFS primary end point], and we [are] looking forward to [seeing] those numbers, [understanding] the impact, and [determining] whether that could [help] create a non-[chemotherapy] neoadjuvant approach for [this subgroup of patients] with MIBC.

Circulating tumor (ct)DNA-guided adjuvant atezolizumab in MIBC: Exploratory analysis of ctDNA dynamics in the IMvigor011 trial.

Sonpavde: Among patients with MIBC, tumor-informed ctDNA, minimal residual disease [MRD]–guided adjuvant therapy with atezolizumab has led to significantly better outcomes in the IMvigor011 trial. Supportive analyses from this practice-informing trial are eagerly anticipated to support this paradigm.

Urinary tumor DNA (utDNA) and circulating tumor DNA (ctDNA) in patients (pts) with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA.

RC48G001: A phase 2 study of disitamab vedotin in HER2-expressing previously treated advanced UC

Merseburger: [These studies], with ctDNA analyses, and RC48G001, [together] reflect the rapid integration of immunotherapy, antibody-drug conjugates, and biomarker-guided strategies into perioperative and advanced-disease settings. These efforts are particularly important as we move toward adaptive treatment algorithms where response assessment and MRD monitoring may guide escalation or de-escalation of therapy in real time [to optimize efficacy while minimizing overtreatment].

References

1. Perioperative enfortumab vedotin plus pembrolizumab vs chemotherapy in cisplatin-eligible muscle-invasive bladder cancer (KEYNOTE-B15/EV-304). ClinicalTrials.gov. Updated February 5, 2026. Accessed February 10, 2026. https://clinicaltrials.gov/study/NCT04700124
2. Padcev plus Keytruda significantly improves survival for patients with muscle-invasive bladder cancer regardless of cisplatin eligibility. Pfizer. News Release. December 17, 2025. Accessed February 10, 2026. https://www.pfizer.com/news/press-release/press-release-detail/padcevtm-plus-keytrudar-significantly-improves-survival
3. Powles T, Grindhelm J, Yilmaz M, et al. Circulating tumor (ct)DNA-guided adjuvant atezolizumab (atezo) in muscle-invasive bladder cancer (MIBC): Exploratory analysis of ctDNA dynamics in the IMvigor011 trial. J Clin Oncol. 2026;44(suppl 7):633. doi:10.1200/JCO.2026.44.7_suppl.633
4. Powles T, Koshkin VS, Rosenberg JE, et al. RC48G001: A phase 2 study of disitamab vedotin in HER2-expressing previously treated advanced UC. J Clin Oncol. 2026;44(suppl 7):LBA631. doi:10.1200/JCO.2026.44.7_suppl.LBA631