Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Display

75P - Effectiveness and safety data from IMreal Cohort 1: patients (pts) with urothelial cancer (UC) receiving atezolizumab after platinum-containing chemotherapy (plt chemo) under real-world conditions

Date

08 Dec 2022

Session

Poster Display

Presenters

Nicolas Girard

Citation

Annals of Oncology (2022) 16 (suppl_1): 100102-100102. 10.1016/iotech/iotech100102

Authors

N. Girard1, S. Shoshkova2, S. Fear3, J.L. Perez Gracia4

Author affiliations

  • 1 Institut Curie, Paris/FR
  • 2 Roche Bulgaria EOOD, Sofia/BG
  • 3 F. Hoffmann-La Roche AG - Switzerland, Basel/CH
  • 4 Clinica Universidad de Navarra, Pamplona/ES

Resources

Login to get immediate access to this content.

If you do not have an ESMO account, please create one for free.

Abstract 75P

Background

Atezolizumab (atezo; anti–PD-L1) is used to treat pts with locally advanced/metastatic UC after plt chemo or who are cisplatin-ineligible and whose tumours have PD-L1 expression ≥5%. IMreal (NCT03782207) is a non-interventional, global, multi-centre, multi-cohort prospective study evaluating the short- and long-term outcomes and safety with atezo in the real-world setting. We report the second interim effectiveness and safety data for Cohort 1.

Methods

Eligible pts were adults with UC receiving atezo either as 2L+ treatment following plt chemo or after disease progression within 12 mo of adjuvant plt chemo. Enrolment occurred from 7 Feb 2019 to 15 Sept 2020. Clinical outcomes and safety data before, during and after treatment with atezo were collected. Pt history data were retrospectively collected. The primary endpoint is overall survival (OS) rate. Key secondary endpoints include progression-free survival (PFS), overall response rate (ORR), pt characteristics and safety.

Results

are based on 116 pts with a data cutoff of 1 Jun 2021. See table for key endpoints and pt characteristics. Overall, 105 pts (91%) had ≥1 AE. Treatment-related (TR) AEs occurred in 38 pts (33%), with Grade 3/4 TRAEs in 6 pts (5%). AEs of special interest occurred in 27 pts (23%); they were considered related in 14 pts (12%). Three pts (3%) had a Grade 5 AE, including 2 (2%) due to complication of device insertion/device obstruction and 1 (1%) due to a bacterial infection; neither was considered related. Table: 75P

Atezo (N=116)
Effectiveness (95% CI)
OS, median, mo 7.5 (5.5, 12.3)
1-y OS rate, % 41 (31.6, 50.1)
PFS, median, mo 4.4 (3.3, 5.7)
ORR, % 31 (21.1, 42.7)
Disease control rate, % 57 (45.4, 68.4)
Duration of response, median, mo 16.4 (12.0, NE)
Demographics, n (%)
Age ≥65 y 77 (66)
Male 94 (81)
White 113 (97)
ECOG PS n=90
0 23 (31)
1 46 (5)
2 15 (17)
3 1 (1)
PD-L1 statusa n=22
Negative 11 (50)
Positive 9 (41)
Unknown 2 (9)
Histology n=116
Urothelial 109 (94)
Non-urothelial 2 (2)
Mixed 5 (4)
Disease statusb
Metastatic 112 (97)
Locally recurrent 24 (21)
Locally advanced unresectable 8 (7)
Clinical stage n=114
IIIB 8 (7)
IVA 58 (51)
IVB 48 (42)

a Per various tests. b Categories are not mutually exclusive.

Conclusions

The OS rate with and safety profile of atezo remain consistent with those observed in pivotal studies, with no new or unexpected safety signals identified.

Clinical trial identification

NCT03782207.

Editorial acknowledgement

Medical writing support was provided by Marcia Gamboa, PhD of Health Interactions, funded by F. Hoffmann-La Roche.

Legal entity responsible for the study

F. Hoffmann-La Roche.

Funding

F. Hoffmann-La Roche.

Disclosure

N. Girard: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, MSD, Roche, Pfizer, Mirati, Amgen, Novartis, Sanofi; Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Roche, Pfizer, Janssen, Boehringer, Novartis, Sanofi, AbbVie, Amgen, Lilly, Grunenthal, Takeda, Owkin; Financial Interests, Institutional, Research Grant, Local: Roche, Sivan, Janssen; Financial Interests, Institutional, Funding: BMS; Non-Financial Interests, Personal, Officer, International Thymic malignancy interest group, president: ITMIG; Other, Personal, Other, Family member is an employee: AstraZeneca. S. Popat: Financial Interests, Personal, Advisory Board: Boehringer Ingelheim, Novartis, Amgen, Janssen, Daiichi Sankyo, AstraZeneca, Bayer, BMS, Blueprint, Merck Serono, Guardant Health, Beigene, Takeda, Lilly, Seattle Genetics, Turning Point Therapeutics, Xcovery, GlaxoSmithKline, MSD, Pfizer, Sanofi; Financial Interests, Personal, Expert Testimony: Roche; Financial Interests, Personal, Invited Speaker: Medscape, VJ Oncology, Touch Medical; Financial Interests, Institutional, Invited Speaker: AstraZeneca, Ariad, Roche, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Trizel, GlaxoSmithKline, Takeda, Turning Point Therapeutics, Roche, Janssen, BMS, Lilly; Financial Interests, Personal, Other, Journal Deputy Editor, Lung Cancer: Elsevier; Financial Interests, Institutional, Other, Sub-investigator: Amgen; Financial Interests, Institutional, Other, Sub-Investigator: MSD, Blueprint, Seattle Genetics; Financial Interests, Institutional, Research Grant: Guardant Health; Non-Financial Interests, Personal, Leadership Role, Foundation Council Member, Unpaid: European Thoracic Oncology Platform; Non-Financial Interests, Personal, Leadership Role, Chair of Steering Committee, Unpaid: British Thoracic Oncology Group; Non-Financial Interests, Personal, Officer, Thoracic Faculty, Unpaid: European Society of Medical Oncology; Non-Financial Interests, Personal, Advisory Role, Mesothelioma Task-force Member, Unpaid: International Association for the Study of Lung Cancer; Non-Financial Interests, Personal, Invited Speaker, Unpaid: Mesothelioma Applied Research Foundation; Non-Financial Interests, Personal, Advisory Role, Honorary Clinical Advisor, Unpaid: ALK Positive UK; Non-Financial Interests, Personal, Advisory Role, Research Advisory Group Member, Unpaid: Ruth Strauss Foundation; Non-Financial Interests, Personal, Advisory Role, Scientific Adivsory Board Member, Unpaid: Lung Cancer Europe. S. Shoshkova: Financial Interests, Personal, Full or part-time Employment: Roche. S. Fear: Financial Interests, Personal, Full or part-time Employment: Roche. J.L. Perez Gracia: Financial Interests, Institutional, Research Grant: Roche, BMS, MSD, Seattle Genetics; Financial Interests, Personal, Speaker’s Bureau: Roche, BMS, Ipsen, MSD, Seattle Genetics; Financial Interests, Personal, Other, Travel Support: Roche, MSD, BMS.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.