GU Cancer Experts Highlight the Most Impactful and Discussion-Worthy Data Presented at ASCO 2026

OncLive® connected with genitourinary oncology experts at the 2026 ASCO Annual Meeting to highlight impactful findings in prostate and bladder cancers and explore their potential relevance to clinical practice. Find their insights below.

Perioperative (neoadjuvant and adjuvant) apalutamide (APA) + androgen deprivation therapy (ADT) vs placebo (PBO) + ADT with radical prostatectomy (RP) in high-risk localized or locally advanced prostate cancer (HR LPC/LAPC): Final analysis of the PROTEUS phase 3 study (LBA1)

Findings from the phase 3 PROTEUS trial (NCT03767244), which were simultaneously published in the New England Journal of Medicine, demonstrated that apalutamide (Erleada) plus androgen deprivation therapy (ADT; n = 1057) reduced the risk of metastasis or death by 20% vs placebo plus ADT by blinded independent central review in patients with high-risk localized or locally advanced prostate cancer (HR, 0.80; 95% CI, 0.67-0.96; P = .02). The investigator-assessed metastasis-free survival (MFS) benefit with the investigational regimen was also shown to be consistent (HR, 0.74; 95% CI, 0.62-0.87; P = .0004).

The apalutamide regimen also led to a 9-fold improvement in the rate of pathologic complete response (pCR)/minimal residual disease (pCR/MRD) at radical prostatectomy (RP), at 8.9% (n = 94) vs 1.0% (n = 10) with placebo plus ADT (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 finding, at 30.6% vs 11.7%, respectively (OR, 3.36; 95% CI, 2.67-4.23; P < .0001).

Alicia Morgans, MD, MPH, Dana-Farber Cancer Institute

“The PROTEUS [trial is among] the most impactful and practice-changing studies when it comes to prostate cancer over the last [few] years because [it provides] information about whether we can include hormonal or systemic therapies in the perioperative space and improve outcomes for patients in terms of cancer control. There have been multiple [negative] studies that have looked at adding [drugs] to surgery in the adjuvant setting, and even in the neoadjuvant setting. [These studies] have suggested that there's a minimal difference in terms of cancer control or haven't adequately assessed long-term cancer control outcomes. PROTEUS is integrating ADT and apalutamide, both before and after surgery, for patients with very high-risk disease to understand if we can prolong the time to metastasis for patients who have a very high risk of having metastatic disease develop despite their surgery.”

Fred Saad, MD, CQ, FRCS, FCAHS, Montreal Cancer Institute

“If you are a urologist [performing] surgery, the PROTEUS [data indicated] that surgery can be an option for high-risk, locally advanced, even lymph node–metastatic disease, and that a difference can be made with [the addition of] ADT and apalutamide. I believe that is a game changer for consideration of surgery in these very high-risk patients.”

Daniel V. Araujo, MD, University of Florida Health

“This was a positive trial for the MFS end point. However, there are a number of caveats about the design and how to interpret [the data], so it's been interesting to see different opinions from different stakeholders. There is [also] an ongoing discussion [regarding whether] this will be implemented as a standard of care or not. But I do commend the authors for conducting such a large trial, and I do think that this is helpful for treating patients.”

TALAPRO-3: Talazoparib (TALA) + enzalutamide (ENZA) compared with placebo (PBO) + ENZA for the treatment of patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) harboring homologous recombination repair (HRR) gene alterations (LBA5007)

Data from the phase 3 TALAPRO-3 trial (NCT04821622) revealed that 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 in patients with metastatic castration-resistant prostate cancer (mCSPC) harboring homologous recombination repair (HRR) gene alterations.

At a median follow-up of 37.6 and 37.7 months in these respective arms, the median radiographic progression-free survival (rPFS) by investigator assessment was not reached (NR; 95% CI, NR-NR) with talazoparib plus enzalutamide (n = 300) vs 45.8 months (95% CI, 37.7-NR) with placebo plus enzalutamide (n = 299; HR, 0.481; 95% CI, 0.357-0.647; P < .0001).The 36-month rPFS rates were 76.6% (95% CI, 70.8%-81.4%) and 56.2% (95% CI, 50.0%-62.0%), respectively. This rPFS benefit was observed in both biomarker-defined subgroups. In patients with BRCA1/2 alterations, talazoparib plus enzalutamide reduced the risk of radiographic progression or death by about 63% (HR, 0.368; 95% CI, 0.222-0.609; P < .0001); in the non–BRCA-mutated HRR subgroup, the reduction was approximately 43% (HR, 0.567; 95% CI, 0.392-0.819; P = .0022).

Fred Saad, MD, CQ, FRCS, FCAHS, Montreal Cancer Institute

“What we saw with TALAPRO-3 was a game changer [with] the introduction of a PARP inhibitor in patients that have HRR-mutated, especially BRCA-mutated, [disease]. We now have solid data, and we made significant differences in BRCA-[mutated patients]. What’s interesting is that in the non-BRACA HRR-mutated patient [population], we're seeing significant delays.”

Enfortumab vedotin plus pembrolizumab (EV+P) vs chemotherapy for previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): 3.5-year follow-up and response analyses from the phase 3 EV-302 study (Abstract 4507)

Results from the 3.5-year follow-up of the phase 3 EV-302/KEYNOTE-A39 study (NCT04223856) showed that, at a median follow-up of 42.8 months, enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda; n = 442) led to a median overall survival (OS) of 33.6 months (95% CI, 26.6-39.8) vs 15.9 months (95% CI, 13.6-18.3) with chemotherapy (n = 444) in patients with previously untreated locally advanced or metastatic urothelial carcinoma (HR, 0.53; 95% CI, 0.45-0.63). The respective 42-month OS rates were 44.0% and 24.6%.

In the enfortumab vedotin arm, the overall response rate (ORR) was 67.5%, including complete response (CR) and partial response (PR) rates of 30.4% and 37.1%, respectively. In the chemotherapy arm, these respective rates were 44.2%, 14.5%, and 29.7%. In the enfortumab vedotin arm, 10.3% of patients achieved a CR directly, and 20.1% of patients achieved a CR after a PR. These rates were 5.9% and 8.6%, respectively, in the chemotherapy arm.

Gopa Iyer, MD, Memorial Sloan Kettering Cancer Center

“The long-term results from EV-302 showed that…patients who initially [achieved a] CR with enfortumab vedotin plus pembrolizumab remained in that CR state. [Approximately] 80% of the patients who were complete responders continue to remain [in response] with 42 months of follow up, which is really astounding.”