Abstract 1033P
Background
Atezo (anti–PD-L1 antibody) is approved for treatment (tx) of pts with advanced NSCLC after prior chemotherapy. IMreal (NCT03782207) is a non-interventional, global, multi-center, multi-cohort prospective study evaluating the short- and long-term outcomes and safety of atezo in pts in the real-world setting. Here we report the second interim efficacy and safety data for Cohort 2.
Methods
Eligible pts were adults with locally advanced/metastatic NSCLC who were receiving atezo monotherapy as second-line (2L) and later tx following chemotherapy. Pts with EGFR or ALK alterations had received an approved targeted therapy prior to atezo. Enrolment occurred from 7 February 2019 to 5 January 2021. Pt medical and tx history data were retrospectively collected; clinical outcomes and safety data before, during and after tx with atezo were also collected. Interim results are based on data for 937 pts with a clinical cutoff of 1 June 2021.
Results
The 1-year OS rate was 48.0% (95% CI: 44.6, 51.4). Median OS was 11.2 months (95% CI: 10.3,12.7). Median PFS was 4.1 months (95% CI: 3.7, 4.5). ORR was 19.5% (95% CI: 16.6, 22.6; Table). Median DOR was 13.2 months (95% CI: 10.6, 16.7). Of the 931 pts in the safety-evaluable population, 765 (82%) had ≥1 AE. The most common AEs (all grades) were asthenia (19%), dyspnoea (12%), cough (10%), arthralgia (10%) and diarrhoea (10%). Grade 3/4 tx-related AEs (TRAEs) occurred in 78 pts (8%). SAEs and TRSAEs occurred in 323 (35%) and 64 pts (7%), respectively. AEs of special interest occurred in 223 pts (24%); these were Grade 3/4 in 55 pts (6%) and TR in 159 pts (17%). Grade 5 TRAEs occurred in 3 pts (0.3%); these were hepatitis, pneumonitis and enterocolitis. Table: 1033P
| Response-evaluable population (n=714) | |
| Responders, n (%) [95% CI] | 139 (19.5) [16.6, 22.6] |
| Disease control rate, n (%) [95% CI] | 447 (62.6) [58.9, 66.2] |
| Complete response, n (%) [95% CI] | 12 (1.7) [0.9, 3.0] |
| Partial response, n (%) [95% CI] | 127 (17.8) [15.1, 20.8] |
| Stable disease, n (%) [95% CI] | 285 (39.9) [36.3, 43.6] |
| Progressive disease, n (%) [95% CI] | 287 (40.2) [36.6, 43.9] |
| Not evaluable, n (%) | 3 (0.4) |
Conclusions
The real-world effectiveness of atezo was consistent with that in the OAK trial, with no new or unexpected safety signals identified.
Clinical trial identification
NCT03782207.
Editorial acknowledgement
Medical writing assistance for this abstract was provided by Marcia Gamboa, PhD of Health Interactions, and funded by F. Hoffmann-La Roche, Ltd.
Legal entity responsible for the study
F. Hoffmann-La Roche, Ltd.
Funding
F. Hoffmann-La Roche, Ltd.
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, Officer, International Thymic malignancy interest group, President: ITMIG; 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, Leadership Role, Foundation Council Member, Unpaid: European Thoracic Oncology Platform; Non-Financial Interests, Leadership Role, Chair of Steering Committee, Unpaid: British Thoracic Oncology Group; Non-Financial Interests, Officer, Thoracic Faculty, Unpaid: European Society of Medical Oncology; Non-Financial Interests, Advisory Role, Mesothelioma Task-force Member, Unpaid: International Association for the Study of Lung Cancer; Non-Financial Interests, Invited Speaker, Unpaid: Mesothelioma Applied Research Foundation; Non-Financial Interests, Advisory Role, Honorary Clinical Advisor, Unpaid: ALK Positive UK; Non-Financial Interests, Advisory Role, Research Advisory Group Member, Unpaid: Ruth Strauss Foundation; Non-Financial Interests, Advisory Role, Scientific Advisory 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, Personal, Invited Speaker: Roche, BMS, MSD; Financial Interests, Personal, Advisory Board: Seattle Genetics, MSD, BMS, Merck; Financial Interests, Institutional, Invited Speaker, Research grant: Roche; Financial Interests, Institutional, Invited Speaker: BMS, Amgen, Seattle Genetics; Financial Interests, Personal, Funding: Ipsen, Roche.