Evidence map›Paper›PMID 39642637›Full record

Trial reportESMO open2024

Atezolizumab monotherapy for metastatic urothelial carcinoma: final analysis from the phase II IMvigor210 trial.

J E Rosenberg, M D Galsky, T Powles, D P Petrylak, J Bellmunt, Y Loriot, A Necchi, J Hoffman-Censits, J L Perez-Gracia, M S van der Heijden and 14 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in ESMO open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  16. Towards biomarker-driven therapies for urothelial carcinoma.Nature reviews. Clinical oncology · 2026
    Review
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  18. IK-175, an Oral Aryl Hydrocarbon Receptor Inhibitor, Alone and with Nivolumab in Patients with Advanced Solid Tumors and Urothelial Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

J E RosenbergMemorial Sloan Kettering Cancer Center, New York, USA. Electronic address: rosenbj1@mskcc.org.
M D GalskyTisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, USA.
T PowlesBarts Cancer Institute, Queen Mary University of London ECMC, Barts Health, London, UK.
D P PetrylakYale Cancer Center, New Haven, USA.
J BellmuntDana-Farber Cancer Institute, PSMAR-IMIM Lab, Harvard Medical School, Boston, USA.
Y LoriotUniversité Paris-Sud, Université Paris-Saclay, Gustave Roussy, Villejuif, France.
A NecchiVita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy.
J Hoffman-CensitsJohns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, USA.
J L Perez-GraciaDepartment of Oncology, Clinica Universidad de Navarra, Pamplona, Spain.
M S van der HeijdenNetherlands Cancer Institute, Amsterdam, Netherlands.
R DreicerUniversity of Virginia Cancer Center, Charlottesville, USA.
I DuránHospital Universitario Virgen del Rocio, Seville, Spain.
D CastellanoHospital 12 de Octubre, Madrid, Spain.
A DrakakiUniversity of California Los Angeles, Los Angeles, USA.
M RetzTechnical University Munich, Munich, Germany.
S S SridharDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Center, Toronto, Canada.
P GrivasTaussig Cancer Institute, Cleveland Clinic, Cleveland, USA.
E Y YuUniversity of Washington and Fred Hutchinson Cancer Center, Seattle, USA.
P H O'DonnellUniversity of Chicago, Chicago, USA.
H A BurrisSarah Cannon Research Institute, Nashville, USA.
S MariathasanGenentech, Inc., South San Francisco, CA, USA.
Y ShiGenentech, Inc., South San Francisco, CA, USA.
E GoluboffGenentech, Inc., South San Francisco, CA, USA.
D BajorinMemorial Sloan Kettering Cancer Center, New York, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundThe IMvigor210 trial demonstrated clinical benefit and manageable toxicity with atezolizumab monotherapy [anti-programmed death-ligand 1 (PD-L1)] in patients with metastatic urothelial carcinoma (UC) in primary analyses. Final efficacy and safety results after long-term follow-up are reported. PATIENTS AND

methodsThis phase II single-arm trial of atezolizumab monotherapy in patients with advanced UC included two cohorts: untreated patients ineligible for cisplatin-based chemotherapy (cohort 1; n = 119) and those previously treated with platinum-based chemotherapy (cohort 2; n = 310). Atezolizumab was administered i.v. (1200 mg every 21 days) until progression or unacceptable toxicity. Primary endpoints were independent review facility-assessed confirmed objective response rate (ORR) per RECIST 1.1 in cohort 1 and independent review facility-assessed ORR per RECIST 1.1 and investigator-assessed modified (m)RECIST in cohort 2. Overall survival (OS), efficacy by PD-L1 status, and safety were also assessed.

resultsAt data cut-off (1 June 2023), the median survival follow-up was 96.4 months (range, 0.2-103.4 months) in cohort 1 and 46.2 months [0.2 (censored)-54.9 months] in cohort 2. In cohort 1, the ORR [95% confidence interval (CI)] was 23.5% (16.2% to 32.2%) in all patients and 28.1% (13.8% to 46.8%) in the PD-L1 tumor-infiltrating immune cell (IC)2/3 subgroup. Median OS (95% CI) was 16.3 months (10.4-24.5 months) overall and 12.3 months (6.0-49.8 months) in the PD-L1 IC2/3 subgroup. In cohort 2, the ORR (95% CI) was 16.5% (12.5% to 21.1%) per RECIST 1.1 and 19.7% (95% CI 15.4% to 24.6%) per mRECIST in all patients and 27.0% (18.6% to 36.8%) and 28.0% (19.5% to 37.9%), respectively, in the PD-L1 IC2/3 subgroup. Median OS (95% CI) was 7.9 months (6.7-9.3 months) in all patients and 11.9 months (9.0-22.8 months) in the IC2/3 subgroup. Treatment-related grade 3/4 adverse events occurred in 21.8% (cohort 1) and 18.7% (cohort 2); one treatment-related death occurred in cohort 1.

conclusionsWith long-term follow-up, atezolizumab monotherapy demonstrated clinically meaningful efficacy with durable responses in a subset of patients with metastatic UC; there were no new safety signals.

Indexed as

Antibodies, Monoclonal, HumanizedAdultAgedAged, 80 and overB7-H1 AntigenCarcinoma, Transitional CellFemaleHumansMaleMiddle AgedTreatment OutcomeUrologic NeoplasmsAntibodies, Monoclonal, HumanizedatezolizumabB7-H1 Antigencheckpoint inhibitorcisplatin-ineligiblelong-term survivalmetastatic urothelial carcinomaPD-L1-highplatinum-refractory

Identifiers

PMID39642637
PMCPMC11667038

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.