
Positive OS for Bladder Cancer Combo, Biomarkers on Tap at ASCO GU 2025
Key Takeaways
- Enfortumab vedotin and pembrolizumab combination shows a 49% reduction in mortality risk for advanced bladder cancer compared to chemotherapy.
- ASCO GU symposium focuses on antibody-drug conjugates, biomarker advancements, and disparities research in genitourinary cancers.
Data on enfortumab vedotin plus pembrolizumab for advanced bladder cancer, along with updates on antibody-drug conjugates, biomarkers, and other cancer treatments, will be highlighted at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU).
The combination treatment for advanced bladder cancer of enfortumab vedotin (Padcev; Astellas) plus pembrolizumab (Keytruda; Merck) cut the risk of death 49% compared with chemotherapy, according to overall survival (OS) findings released ahead of this week’s American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), which takes place in the Moscone West Conference Center in San Francisco, California.
The meeting, which runs from February 13 to February 15, will feature updates for trials of antibody-drug conjugates (ADCs) as well as advances in biomarkers to guide treatment.
ASCO GU brings together experts in medical and radiation oncology and urology for sessions and collaboration on prostate, bladder, and kidney cancers—all of which are
Each day of the meeting has a particular focus: most research presented Thursday involves prostate cancer, Friday is largely devoted to bladder and urothelial cancer, and Saturday sessions involve renal, penile, and testicular cancers.
Keynote on Patient-Centered Care
Thursday’s keynote address will feature
Dahut’s topic comes as the new Trump administration has moved
Across the meeting, disparities research remains a priority, as it has been for several years at all ASCO meetings. At least 22 separate abstracts are focused on disparities; this does not include disparities-related data that may be included in other presentations. Studies to be presented highlight both US-based disparities and global inequities; an example is the analysis from City of Hope’s Regina Barragan-Carrillo, MD, who will present findings on how a disproportionate percentage of studies is drawn from high-income countries.
Therapeutic Results to Highlight Overall Survival
Results will include updates from recent trials.
EV-302
Friday’s agenda features positive final OS results for EV-302 (NCT04223856), which previously demonstrated the efficacy of enfortumab vedotin and pembrolizumab as the standard of care in locally advanced or metastatic bladder cancer. The combination received
“These latest findings from the EV-302 trial reaffirm the primary results, which demonstrated survival improvements for patients treated with enfortumab vedotin and pembrolizumab that were previously unprecedented in locally advanced or metastatic urothelial cancer,” Powles said
Results showed an OS benefit over chemotherapy, with a hazard ratio (HR) of 0.51 (95% CI, 0.43-0.61). Median OS was 33.8 months for the combination, more than double the 15.9 months for chemotherapy. Benefits were seen in all prespecified subgroups, including those cisplatin eligible and ineligible.
Of note, the combination received accelerated approval as a major cisplatin shortage was taking hold in the spring of 2023.
TALAPRO-2
Thursday’s early prostate cancer session will feature late-breaking results from the phase 3 TALAPRO-2 trial (NCT03395197). Neeraj Agrawal, MD, FASCO, of Huntsman Cancer Institute at the University of Utah, will present final OS results for talazoparib (Talzenna; Pfizer) with enzalutamide (Xtandi; Astellas and Pfizer) as a first-line treatment in patients with metastatic castration-resistant prostate cancer.
A centerpiece of the meeting will come at its midpoint, with Friday’s “The ABCs of ADCs: Unleashing the Power of Antibody-Drug Conjugates in Advanced Bladder Cancer,” featuring not only luminaries in the field but also a diversity of challenges, from use of HER2 ADCs in bladder cancer to dealing with toxicity to advancing novel combinations.
Biomarkers Get Attention
Although therapies will receive lots of attention, advances in the use of biomarkers and disease monitoring will have equal billing. On Friday, “Panning for Gold: The Role of ctDNA as a Biomarker for Bladder Cancer” will explore the use of circulating tumor DNA across all stages of disease management. Saturday’s program will feature “Biomarkers and Adjuvant Therapy for Renal Cell Carcinoma: Current State and Future Direction.” Thursday’s poster session on prostate cancer features results on digital physiological monitoring, epigenomic profiling, and liquid biopsies.
The CheckMate 214 trial yielded
The study was funded by the National Institutes of Health.
Therapeutic Combinations
Results for treatment combinations, involving both multiple therapies and combinations with therapy and radiation, abound across all 3 days of the meeting. Saturday’s oral abstract session, for example, will offer the following:
- Final results for COSMIC-313 (NCT03937219), featuring cabozantinib (Cabometyx; Exelixis) in combination with nivolumab (Opdivo; Bristol Myers Squibb) and ipilimumab (Yervoy; Bristol Myers Squibb) in previously untreated aRCC.
- Final follow-up results for CheckMate 9ER (NCT03141177), featuring nivolumab plus cabozantinib compared with sunitinib (Sutent; Pfizer) for previously untreated aRCC
- KEYMAKER-U03 (NCT04626518) substudy 03B, featuring pembrolizumab and targeted therapy combinations for advanced clear cell RCC.
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