SAUL is the largest prospective safety study of a cancer immunotherapy in mUC and provides information about atezolizumab in a real-world setting. This open label, single-arm, multicentre study was designed to assess the safety of atezolizumab as a second- to fourth-line treatment for people with locally advanced or mUC (95%) or non-urothelial carcinoma (5%) of the urinary tract. What makes this study unique is that it included patients with renal impairment, poor performance status (ECOG PS 2) [2], treated asymptomatic CNS metastases or stable controlled autoimmune disease, which have never been included in a study like this previously. The primary endpoint was safety; secondary endpoints included overall survival (OS), progression-free survival (PFS), overall response rate (ORR) and duration of response (DoR).
The data presented at EAU show that the safety of the atezolizumab monotherapy treatment was consistent with the known safety profile of the medicine, even in this broad and complex patient group (see Table). Grade 3-4 adverse events (AEs) occurred in 43% of the patients, and treatment-related grade ≥3 AEs occurred in 13% of the patients, with most common reported side effects being fatigue, asthenia, colitis, and hypertension (each in 1%). AEs leading to treatment discontinuation occurred in 6% of the patients. Additionally, the efficacy results showed an OS of 10 months (95% CI 8.8-11.9 months) in the IMvigor211-like population. In the overall population, median OS was 8.7 months (95% CI 7.8-9.9). The median duration of follow up was 12.7 months.
Table: Adverse events in SAUL
a. Includes but not limited to patients with renal impairment, Eastern Cooperative Oncology Group (ECOG) performance status grade 2, treated asymptomatic central nervous system metastases or stable controlled autoimmune diseaseb. All patients corresponding to the patient population in IMvigor211 (locally advanced or metastatic UC who have progressed during or following a platinum-containing regimen)
*Treatment-related grade 5 AEs (n=7, 0.7%): two cases of dyspnoea, one case each of colitis, intestinal perforation, respiratory failure, chronic kidney disease, drug-induced liver injury.
Prof. Merseburger: “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.
Discussant Prof. Jens Bedke (University Hospital Tübingen, Germany) pointed out that advantages of this trial were its size and involvement of a heterogeneous patient group. He cautioned that while atezolizumab use yielded no increased toxicity, individual data in subgroups was still lacking, and he pointed to the early drops in curves on both arms of the trial. Prof. Bedke also mentioned the costs: €90-95,000 per patient. He concluded that while the data offers some insights, there is a strong need to identify patients that are most likely to benefit from atezolizumab.
Featured video:Prof. Bedke and Prof. Maria José Ribal (University of Barcelona, Spain) discussed the primary results from the SAUL study with Prof. Merseburger.
- Powles T et al. Lancet 2018;391:748-757.
- Sternberg et at. Eur Urol. 2019 Mar 22. pii: S0302-2838(19)30201-5.
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Table of Contents: EAU 2019
Featured articles
Prostate Cancer
Barentsz Trial – Bi-parametric MRI versus multi-parametric MRI
Enzalutamide plus ADT improves outcomes for metastatic hormone-sensitive prostate cancer
Prostate cancer active surveillance: Better patient risk stratification and use of imaging
The role of pelvic lymph node dissection in prostate cancer: Extended vs standard
When to use imaging and imaging-guided therapies
Radioguided surgery is the future?
Bladder Cancer
Largest safety study of its kind with atezolizumab in metastatic bladder cancer
Bladder cancer risk and early detection
Consensus treatment pathway for patients with limited pelvic lymph node involvement in otherwise localised bladder cancer
FGFR3 gene mutation: Favourable prognostic impact in bladder cancer
Bladder cancer in young patients
Spanish study directly links surgical volume with mortality in bladder cancer patients undergoing cystectomy
Updated interim results of phase 2 trial of pembrolizumab for high-risk NMIBC unresponsive to BCG
Robot-assisted radical cystectomy or open radical cystectomy?
Renal Transplantation and Renal Cell Carcinoma
Andrology
Microdissection testicular sperm extraction (microTESE)
Male infertility/Premature ejaculation
Testosterone replacement therapy: Safe and maybe even protective
Focus on treatment of erectile dysfunction and Peyronie’s disease
Penile prosthesis implantation
Functional Urology
Decision aids are too difficult for patients
Lower Urinary Tract Symptoms
The Urodynamics for Prostate Surgery Trial
Minimally invasive surgical techniques must compete against pharmacotherapy in benign prostate hyperplasia (BPH)
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