Meeting
2020 ASCO Virtual Scientific Program
Impact of renal impairment on clinical outcomes in patients (pts) with locally advanced or metastatic (LA/M) urinary tract carcinoma (UTC) treated with atezolizumab (atezo): Analysis of the international SAUL study.
Authors
Margitta Retz
Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany
Margitta Retz , Giuseppe Luigi Banna , Ugo De Giorgi , Thomas Powles , Umberto Basso , Raymond S. McDermott , Anna Llado , Wen-Pin Su , Cristina Ligia Cebotaru , Javier Puente , Alvaro Montesa , Jacques De Greve , Zsuzsanna Kahan , Urbano Anido Herranz , Sabine de Ducla , Julie Pavlova , Simon Fear , Cora N. Sternberg , Florian Seseke
Organizations
Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany, Cannizzaro Hospital, Catania, Italy, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Meldola, Italy, Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew’s Hospital, London, United Kingdom, Istituto Oncologico Veneto (IOV)-IRCCS, Padua, Italy, Adelaide & Meath Hospital, Dublin, Ireland, Istituto Oncologico della Svizzera Italiana (IOSI), Bellinzona, Switzerland, National Cheng Kung Uni Hospital, Tainan, Taiwan, Institutul Oncologic Prof. Dr Ion Chiricuţă Cluj-Napoca, Cluj-Napoca, Romania, Hospital Clinico San Carlos, Madrid, Spain, Unidad de Investigación en Tumores Genitourinarios Centro Nacional de Investigaciones Oncológicas (CNIO)-Instituto de Investigación Biomédica de Málaga (IBIMA), Hospitales Universitarios Regional y V de la Victoria de Málaga, Málaga, Spain, UZ Brussels, Brussels, Belgium, Szegedi Tudományegyetem, Általános Orvostudományi Kar, Szent-Györgyi Albert Klinikai Kozpont, Onkoterapias Klinik, Szeged, Hungary, Complejo Hospitalario Universitario de Santiago (CHUS), Santiago De Compostela, Spain, F. Hoffmann-La Roche Ltd, Basel, Switzerland, San Camillo and Forlanini Hospitals, Rome, Italy and Englander Institute of Precision Medicine, Weill Cornell Medicine (current affiliation), New York, NY, Krankenhaus Martha-Maria Halle-Dölau, Halle, Germany
Research Funding
Pharmaceutical/Biotech Company
F Hoffmann-La Roche Ltd, Basel, Switzerland
Background: Atezo, which targets PD-L1, is an approved therapy for LA/M urothelial carcinoma based on the IMvigor210 and IMvigor211 trials. The single-arm SAUL study (NCT02928406) showed consistent activity and safety in a broader population, including understudied scenarios, eg pts with renal impairment or other IMvigor211 exclusion criteria. Methods: Pts with LA/M UTC received atezo 1200 mg q3w until disease progression or unacceptable toxicity. The primary endpoint was safety; secondary endpoints included overall response rate (ORR) and overall survival (OS). Post hoc analyses explored outcomes in pts classified as: chemotherapy (CT) ineligible (calculated creatine clearance [CrCl] 15–< 30 mL/min); cisplatin ineligible and carboplatin eligible (CrCl 30–< 60 mL/min); or cisplatin eligible (CrCl ≥60 mL/min). Results: Of 1004 enrolled pts, 46 (5%) were classified as CT ineligible and 420 (42%) as cisplatin ineligible. Results are summarized below. Conclusions: These post hoc analyses suggest pts typically considered cisplatin or CT ineligible are candidates for atezo. Pts with renal impairment achieved similar ORR and DCR to pts with CrCl ≥60 mL/min, without increased toxicity. Imbalances in pt characteristics may explain numerical differences in OS. Clinical trial information: NCT02928406.
| CrCl, mL/min | 15–< 30 (n = 46) | 30–< 60 (n = 420) | ≥60 (n = 529) |
|---|---|---|---|
| Median age, y (range) | 75 (48–92) | 72 (40–93) | 63 (34–86) |
| Female, n (%) | 15 (33) | 112 (27) | 97 (18) |
| Visceral metastases, n (%) | 18 (39) | 161 (38) | 194 (37) |
| No prior CT for LA/M UTC, n (%) | 13 (28) | 145 (35) | 223 (42) |
| PD-L1 IC 2/3,a n (%) | 10 (22) | 115 (27) | 138 (26) |
| Median atezo duration, mo (range) | 3.0 (0.0–18.7) | 2.8 (0.0–18.9) | 2.8 (0.0–19.0) |
| Grade ≥3 AEs, n (%) | |||
| Any | 21 (46) | 188 (45) | 239 (45) |
| Treatment related | 3 (7) | 51 (12) | 73 (14) |
| Special interest | 1 (2) | 23 (5) | 43 (8) |
| AE leading to atezo withdrawal, n (%) | 3 (7) | 22 (5) | 32 (6) |
| Median OS, mo (95% CI) | 5.7 (3.4–11.0) | 8.5 (7.0–10.8) | 9.4 (8.0–10.4) |
| ORR, n (%) [95% CI] | 6 (13) [5–26] | 62 (15) [12–19] | 67 (13) [10–16] |
| DCR,b n (%) [95% CI] | 21 (46) [31–61] | 179 (43) [38–48] | 197 (37) [33–42] |
DCR = disease control rate
a≥5% of tumor immune cells express PD-L1
bComplete/partial response or stable disease for ≥4 wk
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Abstract Details
Session Type
Poster Session
Session Title
Genitourinary Cancer—Kidney and Bladder
Track
Genitourinary Cancer—Kidney and Bladder
Sub Track
Bladder Cancer
Clinical Trial Registration Number
NCT02928406
Citation
J Clin Oncol 38: 2020 (suppl; abstr 5036)
DOI
10.1200/JCO.2020.38.15_suppl.5036
Abstract #
5036
Poster Bd #
105
Abstract Disclosures
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