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  • / Analysis of clinical outcomes according to response status in prospective clinical trials of atezolizumab (atezo) in pretreated locally advanced/metastatic urothelial carcinoma (mUC).

Analysis of clinical outcomes according to response status in prospective clinical trials of atezolizumab (atezo) in pretreated locally advanced/metastatic urothelial carcinoma (mUC).

Abstract Poster

Authors

null

Jens Bedke

Department of Urology, University of Tuebingen, Tuebingen, Germany

Jens Bedke , Axel Stuart Merseburger , Yohann Loriot , Daniel Castellano , Ernest Choy , Ignacio Duran , Jonathan E. Rosenberg , Daniel Peter Petrylak , Robert Dreicer , Jose Luis Perez-Gracia , Jean H. Hoffman-Censits , Michiel Simon Van Der Heijden , Viraj Degaonkar , Lars Thiebach , Sabine de Ducla , Simon Fear , Thomas Powles , Cora N. Sternberg

Organizations

Department of Urology, University of Tuebingen, Tuebingen, Germany, Department of Urology, Campus Lübeck, University Hospital Schleswig-Holstein, Lübeck, Germany, Department of Cancer Medicine and INSERM U981, Université Paris-Sud, Université Paris-Saclay, Gustave Roussy, Villejuif, France, Medical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain, CREATE Centre, Section of Rheumatology, Division of Infection and Immunity, Cardiff University School of Medicine, Cardiff, United Kingdom, Hospital Universitario Virgen del Rocio, Seville, Spain and Hospital Universitario Marques de Valdecilla, Santander, Spain, Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, Smilow Cancer Center, Yale University, New Haven, CT, Division of Hematology/Oncology, University of Virginia School of Medicine, Charlottesville, VA, Clínica Universidad de Navarra, University of Navarra, Pamplona, Spain, Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, Department of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, Netherlands, Genentech, Inc., South San Francisco, CA, Roche Pharma AG, Grenzach-Wyhlen, Germany, F. Hoffmann-La Roche Ltd, Basel, Switzerland, Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew’s Hospital, London, United Kingdom, San Camillo and Forlanini Hospitals, Rome, Italy and Englander Institute of Precision Medicine, Weill Cornell Medicine, New York, NY

Research Funding

Pharmaceutical/Biotech Company
F. Hoffmann La-Roche Ltd

Background: Atezo is an approved therapy for mUC based on the IMvigor210 (IM210) and IMvigor211 (IM211) phase 2 and 3 trials. The single-arm phase 3b SAUL study in a broader patient (pt) population showed consistent efficacy and safety. The value of complete response to immunotherapy is well recognized, but less is known about the benefit of partial response (PR) or stable disease (SD). We performed post hoc analyses of outcomes in pts with PR/SD in atezo trials. Methods: Pts with mUC received atezo 1200 mg q3w until disease progression (PD) or unacceptable toxicity. Baseline characteristics, efficacy and safety were analyzed in pts achieving PR or SD in IM210 cohort 2 (2nd line), IM211 (atezo and chemotherapy [CT] arms analyzed separately) and SAUL. Data cutoffs were 5/5/15, 3/13/17 and 9/16/18, respectively. Results: The analysis population included 229 PR and 583 SD pts (183 and 421, respectively, treated with atezo); ~40% of pts had 0 Bellmunt risk factors. Baseline characteristics were generally similar between trials. PD-L1 IC 2/3 was more common in PR than SD pts in atezo-treated (41% vs 26%) and CT-treated (37% vs 23%) pts. Median time to best response (PR or SD) was 2.1 mo across trials and treatments. In PR pts, disease control (DC) and overall survival (OS) durations were longer with atezo than CT (Table). Durations of DC and OS were shorter in SD than PR pts; OS was numerically longer with atezo than with CT in the SD population. Presence of more Bellmunt risk factors was associated with worse OS with CT but showed only a weak (SD pts) or no (PR pts) association in atezo-treated pts. Conclusions: Pts achieving a PR or SD have meaningful OS expectancy; pts with PR on atezo have sustained DC. Clinical trial information: NCT02108652; NCT02302807; NCT02928406.

Median duration,
mo (95% CI)		AtezoCT
IM210IM211SAULIM211
PR(n=31)(n=46)(n=106)(n=46)
Exposure20.214.511.46.5
DCa16.6
(11.0–NE)		15.9
(8.8–NE)		NE
(11.7–NE)		7.8
(5.7–9.7)
OSNE
(NE–NE)		NE
(NE–NE)		NE
(NE–NE)		19.9
(14.3–21.9)
SD(n=66)(n=92)(n=263)(n=162)
Exposure5.66.27.03.7
DCa2.7
(2.1–4.2)		4.3
(3.5–6.1)		4.1
(3.7–4.2)		3.7
(2.6–4.2)
OS12.7
(9.2–17.0)		16.6
(12.4–NE)		17.9
(14.7–NE)		11.3
(9.9–12.7)

aFrom 1st PR/SD until 1st PD/death. NE=not estimable.

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Abstract Details

Meeting

2020 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Prostate Cancer; Urothelial Carcinoma; Penile, Urethral, Testicular, and Adrenal Cancers

Track

Urothelial Carcinoma,Adrenal Cancer,Penile Cancer,Prostate Cancer - Advanced,Prostate Cancer - Localized,Testicular Cancer,Urethral Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT02108652; NCT02302807; NCT02928406

Citation

J Clin Oncol 38, 2020 (suppl 6; abstr 492)

Abstract #

492

Poster Bd #

H15

Abstract Disclosures

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