ASCO 2026 GU Oncology Data Highlights Apalutamide and Enfortumab Vedotin

Phase 3 Outcomes in Prostate Cancer: PROTEUS and TALAPRO-3

New data presented in Chicago has provided clarity on treatment pathways for high-risk prostate cancer. The phase 3 PROTEUS trial (NCT03767244), which was simultaneously published in the New England Journal of Medicine, evaluated the use of apalutamide (Erleada) combined with androgen deprivation therapy (ADT; n = 1057) versus placebo (PBO) and ADT in patients with high-risk localized or locally advanced prostate cancer (HR LPC/LAPC). According to reporting from OncLive, the apalutamide regimen reduced the risk of metastasis or death by 20% compared with the placebo group by blinded independent central review (HR, 0.80; 95% CI, 0.67-0.96; P = .02). The investigator-assessed metastasis-free survival (MFS) benefit with the investigational regimen was shown to be consistent (HR, 0.74; 95% CI, 0.62-0.87; P = .0004).

The study also highlighted a significant difference in pathologic complete response/minimal residual disease (pCR/MRD) rates at radical prostatectomy. Patients receiving apalutamide achieved a rate of 8.9% (n = 94), compared with 1.0% (n = 10) for those in the placebo arm (OR, 10.17; 95% CI, 5.27-19.64; P < .0001). More than half of the responses in the apalutamide arm were pCRs. An exploratory analysis of residual cancer burden corroborated the pCR/MRD findings at 30.6% vs 11.7%, respectively (OR, 3.36; 95% CI, 2.67-4.23; P < .0001). Beyond localized disease, the TALAPRO-3 trial (NCT04821622) examined patients with metastatic castration-sensitive prostate cancer (mCSPC) harboring homologous recombination repair (HRR) gene alterations. The combination of talazoparib (Talzenna) and enzalutamide (Xtandi) led to a 52% reduction in the risk of radiographic progression or death vs placebo plus enzalutamide.

Advancements in GI Oncology and Pancreatic Cancer

ASCO 2026 also featured significant developments in gastrointestinal (GI) oncology. The EMERALD-3 trial advanced the use of immunotherapy in unresectable hepatocellular carcinoma (HCC), while ASTRUM-006 demonstrated the potential of perioperative immunotherapy in PD-L1-positive resectable gastric cancer. Experts noted a growing role for immunotherapy in earlier-stage diseases, moving away from a one-size-fits-all approach toward tailored therapies and biomarker testing.

One of the most discussed breakthroughs was in pancreatic cancer. Phase 3 results for daraxonrasib by RevMed in metastatic pancreatic cancer were described as truly remarkable, earning standing ovations and widespread acclaim at the meeting. This achievement is seen as a sign of progress for a disease long associated with poor outcomes.

Translational Science and Leadership Perspectives

Opening the meeting, ASCO President Eric J. Small framed translation as the central responsibility of the oncology community. Speaking to delegates, he emphasized that the value of scientific discovery lies in its ability to improve patient outcomes across settings and populations. Small described three dimensions of translation: moving laboratory science into the clinic, translating clinical trial evidence into real-world patient-centered care, and ensuring innovation reaches every patient. His remarks connected the scientific program to a broader ethical and practical challenge: ensuring that breakthroughs presented at the meeting are ultimately reflected in better care. Small also brought a personal dimension to the theme, reflecting on the death of his partner, Amy Lin, from metastatic clear-cell ovarian cancer.

To gain further perspective on the biggest news in genitourinary cancers, OncLive gathered insights from experts including Daniel V. Araujo, MD, a medical oncologist at the University of Florida Health in Gainesville; Alicia Morgans, MD, MPH, a physician and medical director of the Survivorship Program at Dana-Farber Cancer Institute and associate professor of medicine at Harvard Medical School; and Gopa Iyer, MD, the section head of the Bladder Cancer Department at Memorial Sloan Kettering Cancer Center.

Equity and Access in the Global Oncology Landscape

A recurring message from the opening session was that progress in oncology must be measured not only by new treatments but also by whether patients can access them. Small highlighted the need for diverse clinical trial representation, stronger bonds of trust between patients and community oncologists, and systems that reduce barriers to timely, evidence-based care. The meeting also highlighted the human side of oncology, with personal stories shared by figures such as Zainab Shinkafi-Bagudu regarding her experience with the Union for International Cancer Control.

The 2026 congress program reflected these goals through sessions covering immunotherapy, targeted therapies, liquid biopsies, novel imaging, biomarkers, early detection, survivorship, quality of life, cancer disparities, global oncology, supportive care, and health policy.