Breaking News Session: Prostate & Bladder Cancer trials

This Monday, the last full day of EAU19 in Barcelona, Prof. Axel Merseburger (DE) presented the results of the SAUL trial during the early-morning Breaking News session on prostate cancer. SAUL is the largest prospective clinical trial of immunotherapy in advanced urinary tract carcinoma, examining the use of atezolizumab.

Merseburger concluded that atezolizumab is a tolerable and effective treatment, even in complex comorbid populations: “Its efficacy overall and in the IMvigor211-like subgroup is consistent with previous pivotal anti-PD-L1/PD-1 UC trials. The median overall survival in SAUL was 10 months in the IMvigor211-like population (n=643) and 8.7 months in the ITT population (n=1004).”

“SAUL confirms the tolerability of atezolizumab in a ‘real-world’ UC and non-UC population. Efficacy in both the IMvigor211-like subgroup and the broader unselected population is consistent with previous anti-PD-L1/PD-1 pivotal UC trials. These results support use of atezolizumab in UC or non-UC, including patients with limited available treatment options.

Prof. Jens Bedke (DE) called the SAUL trial a “window of opportunity”, and praised the trial for its size and  variety of patient groups involved. He cautioned that while atezolizumab use yielded no increased toxicity, individual data on after-effects (AE) with special interest in respective subgroups was still lacking. Bedke also mentioned the incremental costs: €90-95,000 per patient.

ARCHES

At the same session, Prof. Antonio Alcaraz (ES) presented the latest findings of the ARCHES trial. ARCHES examines enzalutamide in combination with androgen deprivation therapy for men with metastatic hormone-sensitive PCa.

“We can report the efficacy and safety of enzalutamide in combination with ADT in men with mHSPC, based on geographic location, disease volume (high or low), Gleason score (<8 or ≥8), prior docetaxel, prior local therapy and in newly-diagnosed patients,” announced Alcaraz.

Noel Clarke (GB) discussed the trial, placing it in the context of a number of studies looking at combination of ADT and enzalutamide: “Radiographic progression-free survival is clearly improved and we must compare these with the results of trials studying abiraterone. This may translate to improved overall survival but further follow-up is required.”

“The ‘volume’ and ‘risk’ exclusions need to be re-visited in relation to the use of combination ADT strategies in hormone-sensitive MPC.”

Prof. Jens Bedke (DE) and Prof. Maria José Ribal discussed the primary results from the SAUL study with Prof. Axel Merseburger (DE). See the video discussion here.