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.