Jason Hafron, MD, recaps prostate cancer data from ESMO 2025

The 2025 European Society for Medical Oncology (ESMO) Congress, in Berlin, Germany, delivered several noteworthy data readouts in genitourinary oncology. Prostate cancer in particular saw a wave of important updates, with new evidence emerging on established therapies that continue to refine the treatment landscape.

To help make sense of these developments, Jason M. Hafron, MD, chief medical officer at the Michigan Institute of Urology, sat down with Urology Times® to discuss key findings from EMBARK, PSMAddition, CAPItello-281, and other significant studies in the space.

Hafron began the discussion by outlining updated data from the phase 3 EMBARK trial (NCT02319837). EMBARK had previously met its primary end point by demonstrating that enzalutamide (Xtandi) plus leuprolide significantly extended metastasis-free survival compared with leuprolide alone in patients with biochemically recurrent prostate cancer. New data presented at ESMO 2025 further strengthened these findings, showing that the combination also led to a statistically significant improvement in overall survival (HR, 0.597; 95% CI, 0.444 to 0.804; P = .0006) in these patients.¹

Hafron then turned to the PSMAddition study (NCT04720157), another major highlight of the meeting. Results showed that the addition of ¹⁷⁷Lu-PSMA-617 to androgen deprivation therapy (ADT) plus an androgen receptor pathway inhibitor (ARPI) significantly extended radiographic progression-free survival (rPFS) for patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC).²

Continuing in the mHSPC space, Hafron pointed to the phase 3 CAPItello-281 trial (NCT04493853) as a meaningful advance. The study found that capivasertib (Truqap), added to abiraterone acetate (Zytiga), prednisone, and ADT, significantly prolonged rPFS in patients with PTEN-deficient de novo mHSPC.³ The median rPFS was 33.2 months with capivasertib vs 25.7 months with placebo (HR, 0.81; P = .034), with consistent benefits across secondary end points.

Looking ahead, Hafron noted that the field is moving toward a biomarker-driven space, led by triplet regimens using ADT plus an ARPI plus another agent.

REFERENCES

1. Shore ND, de Almeida Luz M, De Giorgi U, et al. Overall survival with enzalutamide in biochemically recurrent prostate cancer. Presented at: European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. LBA87. https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.esmo/static/esmo2025_abstracts/LBA87.html.pdf

2. Tagawa ST, Sartor O, Piulats JM, et al. Phase III trial of [177Lu]Lu-PSMA-617 combined with ADT + ARPI in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (PSMAddition). Presented at: 2025 European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. LBA6. https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.esmo/static/esmo2025_abstracts/LBA6.html.pdf

3. Fizazi K, Clarke NW, De Santis M, et al. A phase III study of capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281. Presented at: 2025 ESMO Congress; October 17-21, 2025; Berlin, Germany. Abstract 2383O. https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.esmo/static/esmo2025_abstracts/2383O.html.pdf