Full Abstract Release for EAU 2023

The 38th Annual European Association of Urology (EAU) Congress is happening in Milan from March 10-13. Nearly 3000 world-class plenary, thematic, poster, video and special sessions will take place in the span of four days, in a hybrid in-person/virtual format.

EAU has released the abstracts as of February 10th, and Ferma.AI has analyzed all 3214 abstracts, alongside social media buzz, to identify the most relevant and highly anticipated sessions among Urologists. The priority sessions can be classified into two main groups:

  • Phase 3 Prostate Cancer Trial Updates
  • PD-1/L1 Agents for Treatment of Urothelial/Bladder Cancer

Phase 3 Prostate Cancer Trial Updates

PROpel (NCT03732820,NCT05171816) Abstract

AstraZeneca and Merck will discuss efficacy findings from their PROpel study testing olaparib or a placebo with abiraterone and prednisone/prednisolone, regardless of HRRm status. At DCO2, 16% of patients in the olaparib group had PFS2 events vs 25% in the placebo group. 29% of OS events were reported for the olaparib group vs 38% for the placebo group. Exploratory analyses showed that olaparib provided clinically meaningful benefits in asymptomatic/mildly symptomatic patients, with a median rPFS of 27.6 months.

ARASENS (NCT02799602) Abstract

Bayer and Orion Pharma will present results from the ARASENS study for metastatic prostate cancer. Darolutamide (DARO) combined with androgen-deprivation therapy (ADT) and docetaxel (DOC) significantly reduced death risk by 32.5% compared to placebo plus ADT plus DOC, with no increase in treatment-related adverse events. DARO + ADT + DOC prolonged overall survival in patients with high and low volume and risk disease. DARO's superior safety profile establishes a new standard of care for metastatic hormone sensitive prostate cancer.

CYCLONE 3: (NCT05288166) Abstract

Lilly announces trial design for the CYCLONE 3 study, a double-blind, placebo-controlled study evaluating abemaciclib, a selective inhibitor of cyclin-dependent kinase 4 and 6, in combination with abiraterone and prednisone for high-risk metastatic hormone-sensitive prostate cancer. Approximately 900 patients with high-risk mHSPC will be randomized to receive either abemaciclib or placebo. The primary endpoint is radiographic progression-free survival, and secondary endpoints include castration-resistant prostate cancer-free survival, overall survival, time to pain progression, safety, and pharmacokinetics. The study aims to expand therapeutic options for high-risk mHSPC patients, who experience poorer outcomes, despite the survival benefit observed with novel hormonal agents.

PD-1/L1 Agents for Treatment of Urothelial/Bladder Cancer

PURE-01 (NCT02736266) Abstract

In Merck’s PURE-01 study, patients with muscle-invasive bladder cancer were treated with pembrolizumab and then underwent bladder multiparametric MRI before radical cystectomy. The VIRADS score, which measures tumor visibility on MRI, was used to predict pathological downstaging. Both pre- and post-pembro VIRADS scores were significantly associated with a better response to treatment and a higher chance of achieving pT≤1 endpoint. Post-pembro VIRADS emerged as an important feature for selecting patients for bladder-sparing strategies. VIRADS changes post-pembro were also associated with changes in molecular subtype.

IMvigor210, IMvigor211 (NCT02108652,NCT02302807,NCT02951767) Abstract

The studies IMvigor210 and IMvigor211 by Roche examine the correlation between immune-related adverse events (irAEs) and cancer-related outcomes in patients with advanced urothelial cancer who are being treated with immune checkpoint inhibitors (ICIs). The data came from two trials and included 896 patients. The results showed that the occurrence of irAEs was inversely associated with disease progression, overall mortality, and cancer-specific mortality. The administration of systemic corticosteroids was not associated with worse oncological outcomes. These findings suggest that the development of irAEs while receiving atezolizumab treatment is associated with improved oncological outcomes and is not affected by systemic corticosteroids administration.

KEYNOTE-057 (NCT02625961) Abstract

Merck's phase 2 KEYNOTE-057 study, specifically Cohort C, aims to assess the safety and effectiveness of combining pembrolizumab with either the LAG-3 inhibitor favezelimab or the TIGIT inhibitor vibostolimab in patients who have high-risk, BCG-unresponsive non-muscle invasive bladder cancer with CIS ± papillary tumors. Eligible patients will be randomized to receive either coformulation of pembrolizumab and favezelimab or pembrolizumab and vibostolimab. The primary endpoint is the 12-month complete response rate of high-risk NMIBC, with secondary endpoints including duration of response, progression-free survival, and overall survival. Tumor evaluations will be performed regularly for up to 5 years.

Looking Forward

Ferma.AI  will be closely monitoring the conference data releases, as well as reactions across social media and healthcare news. To learn more about how Ferma.AI can enhance your conference coverage and insights at 40% lower cost, book a 30-minute meet here.