Clinical outcomes according to PD-L1 status and age in the prospective international SAUL study of atezolizumab (atezo) for locally advanced or metastatic urothelial carcinoma (UC) or non-UC of the urinary tract.

Authors

Cora Sternberg

Cora N. Sternberg

Weill Cornell Medicine, New York, NY

Cora N. Sternberg , Axel Stuart Merseburger , Ernest Choy , Daniel E. Castellano , Fernando Lopez-Rios , Nicholas James , Giuseppe Luigi Banna , Ugo De Giorgi , Cristina Masini , Aristotelis Bamias , Xavier Garcia del Muro , Thomas Powles , Ignacio Duran , Craig Gedye , Marija Gamulin , Friedemann Zengerling , Lajos Geczi , Sabine de Ducla , Simon Fear , Yohann Loriot

Organizations

Weill Cornell Medicine, New York, NY, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany, CREATE Centre, Section of Rheumatology, Division of Infection and Immunity, Cardiff University School of Medicine, Cardiff, United Kingdom, Medical Oncology Service, Hospital Universitario 12 de Octubre, Madrid, Spain, Hospital Universitario HM Sanchinarro, Madrid, Spain, Institute of Cancer and Genomic Services, University of Birmingham, and Cancer Centre, Queen Elizabeth Hospital, Birmingham, United Kingdom, Cannizzaro Hospital, Catania, Italy, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy, Medical Oncology Unit, AUSL-IRCCS Reggio Emilia, Reggio Emilia, Italy, National and Kapodistrian University of Athens, Alexandra Hospital, Athens, Greece, Institut Catala d’Oncologia, IDIBELL, Barcelona, Spain, Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew’s Hospital, London, United Kingdom, Hospital Universitario Virgen del Rocio, Seville (current affiliation: Hospital Universitario Marques de Valdecilla, Santander, Spain, Calvary Mater Newcastle, Waratah, Australia, University Hospital Centre ‘Zagreb’, Zagreb, Croatia, Department of Urology, University Hospital Ulm, Ulm, Germany, National Institute of Oncology, Budapest, Hungary, F. Hoffmann-La Roche Ltd, Basel, Switzerland, Department of Cancer Medicine and INSERM U981, Université Paris-Sud, Université Paris-Saclay, Gustave Roussy, Villejuif, France

Research Funding

Pharmaceutical/Biotech Company

Background: Atezo, a monoclonal antibody targeting PD-L1, is an approved therapy for locally advanced/metastatic UC based on IMvigor210 and IMvigor211 phase II and III trials. The single-arm SAUL study (NCT02928406) with a broader patient (pt) population demonstrated median overall survival (OS) of 8.7 months and a safety profile consistent with previous atezo trials. Methods: Pts with locally advanced/metastatic UC or non-UC of the urinary tract received atezo 1200 mg every 3 weeks until disease progression or unacceptable toxicity. Populations excluded from IMvigor211 (renal impairment, ECOG PS 2, treated asymptomatic CNS metastases, stable controlled autoimmune disease, concomitant steroids, HIV positive, non-UC) were eligible. The primary endpoint was safety; OS and overall response rate (ORR) were secondary endpoints. Predefined subgroup analyses included outcomes according to PD-L1 status (VENTANA SP142) and age in the overall population (and the IMvigor211-like subgroup for PD-L1). Results: Between Nov 2016 and Mar 2018, 1004 pts were enrolled; 997 received atezo. Efficacy is summarized below. Incidences of grade ≥3 treatment-related adverse events were similar irrespective of PD-L1 status (overall IC 0/1 vs 2/3: 11% vs 16%; IMvigor211-like IC 0/1 vs 2/3: 11% vs 15%) or age (≥65 y: 13%; ≥75 y: 12%; ≥80 y: 10%). Conclusions: OS and ORR appear more favorable in IC 2/3 vs IC 0/1 subgroups (overall and in the IMvigor211-like population). Atezo was effective and well tolerated across subgroups including elderly pts. Clinical trial information: NCT02928406

EndpointAll pts, PD-L1
IMvigor211-like, PD-L1
All pts, age
IC 0/1 (n=666)IC 2/3 (n=268)IC 0/1 (n=427)IC 2/3 (n=176)≥65 y (n=624)a≥75 y (n=227)a≥80 y (n=78)a
Deaths, n (%)388 (58)132 (49)235 (55)82 (47)335 (54)128 (56)44 (56)
Median OS, months (95% CI)7.9 (6.8–9.1)11.6 (8.8–18.8)9.0 (7.8–10.4)14.5 (9.5–18.8)8.5 (7.5–10.9)8.3 (7.3–10.9)8.3 (5.4–11.2)
6-month OS rate, % (95% CI)57 (53–61)67 (61–72)61 (56–66)72 (65–78)60 (56–64)61 (54–67)59 (47–69)
ORR, % (95% CI)10 (8–13)21 (16–26)10 (7–13)23 (17–30)14 (12–17)13 (9–18)8 (3–16)

aSubgroups not mutually exclusive

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Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Genitourinary (Nonprostate) Cancer

Track

Genitourinary Cancer—Kidney and Bladder

Sub Track

Bladder Cancer

Clinical Trial Registration Number

NCT02928406

Citation

J Clin Oncol 37, 2019 (suppl; abstr 4519)

DOI

10.1200/JCO.2019.37.15_suppl.4519

Abstract #

4519

Poster Bd #

345

Abstract Disclosures