Positive OS for Bladder Cancer Combo, Biomarkers on Tap at ASCO GU 2025

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 on the rise in the United States due to increased obesity rates and an aging population.

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

William Dahut, MD, chief scientific officer of the American Cancer Society

Thursday’s keynote address will feature William L. Dahut, MD, the chief scientific officer of the American Cancer Society. The session, “Creative Innovation: Driving Science to Improve Patient-Centered Care,” will touch on the need for equity and access through steps that include decentralized clinical trials; Dahut told the ASCO Daily News such actions could have a positive effect on enrolling more Black men in prostate cancer trials.

Dahut’s topic comes as the new Trump administration has moved to de-emphasize diversity, equity, and inclusion; specifically, an FDA draft guidance regarding diversity in clinical trials was removed from the website.

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 accelerated approval in April 2023. Thomas Powles, MD, PhD, of Barts Cancer Institute, London, will present the findings.

Thomas Powles, MD, PhD | Image credit: Barts Cancer Institute

“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 in a statement. “These data show that the potential survival benefit has become even more robust with extended follow up and further solidify the combination as standard of care.”

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 an abstract to be presented by Dana-Farber Cancer Institute’s Wenxin Xu, MD, on the potentially new and minimally invasive biomarker: “Evaluation of circulating kidney injury marker-1 (KIM-1) as a prognostic and predictive biomarker in advanced renal cell carcinoma (aRCC).”

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.