Abstract 123P
Background
IMpower010 (NCT02486718) showed a statistically significant benefit in primary-endpoint disease-free survival (DFS) with adjuvant atezo vs BSC in resected stage II-IIIA PD-L1 tumour cell (TC) ≥1% (SP263) NSCLC after platinum-based chemotherapy. This finding led to the approval of atezo in this setting in the US, China, Japan and other countries and to its approval for stage II-IIIA PD-L1 TC ≥50% NSCLC in the EU and other countries. At the first pre-specified interim analysis (IA) of OS (cutoff 18 Apr 2022), the secondary endpoint of OS in the ITT population was not mature, but OS is of clinical interest in this curative setting; in pts with stage II-IIIA and stage II-IIIA PD-L1 ≥1% NSCLC, the respective OS HRs were 0.95 (95% CI: 0.74, 1.24) and 0.71 (95% CI: 0.49, 1.03) (Wakelee JTO 2022; 17:S2). We present OS data in pts with stage II-IIIA PD-L1 TC ≥50% NSCLC.
Methods
The IMpower010 study design and primary endpoint analysis have been reported (Felip Lancet 2021). We report exploratory OS in pts with stage II-IIIA (UICC/AJCC v7) PD-L1 TC ≥50% (VENTANA SP263 assay) NSCLC and updated safety at this OS IA.
Results
In 229 pts with stage II-IIIA PD-L1 TC ≥50% NSCLC, the OS HR was 0.43 (95% CI: 0.24, 0.78); after excluding 20 pts with known EGFR/ALK+ status, the OS HR was 0.42 (95% CI: 0.23, 0.78). The OS subgroup analysis is presented in the table. No new safety signals emerged since the previous cutoff.
Conclusions
Pts with stage II-IIIA PD-L1 TC ≥50% NSCLC derived OS benefit with atezo vs BSC. OS benefit was consistent across most pt subgroups, albeit with limited numbers in this exploratory analysis. The atezo safety profile remained unchanged. These data support the previously reported positive benefit-risk profile of adjuvant atezo in stage II-IIIA PD-L1+ resected NSCLC and contribute further evidence to support this new standard of care for patients with early-stage resectable NSCLC. Table: 123P
OS in stage II-IIIA PD-L1 TC ≥50% pt subgroups
| Pts, n | Unstratified OS HR (95% CI) | ||
| Atezo 115 | BSC 114 | ||
| Age <65 y ≥65 y | 70 45 | 68 46 | 0.44 (0.20, 0.97) 0.42 (0.17, 1.04) |
| Sex Male Female | 89 26 | 78 36 | 0.39 (0.19, 0.80) 0.58 (0.20, 1.68) |
| ECOG PS 0 1 | 71 44 | 60 53 | 0.38 (0.16, 0.90) 0.51 (0.22, 1.19) |
| Histology Squamous Nonsquamous | 47 68 | 45 69 | 0.58 (0.22, 1.51) 0.36 (0.17, 0.79) |
| Stage II IIIA | 62 53 | 57 57 | 0.63 (0.28, 1.44) 0.30 (0.12, 0.74) |
| Lymph node status N0 N1 N2 | 30 43 42 | 21 52 41 | 0.74 (0.21, 2.55) 0.38 (0.14, 1.07) 0.36 (0.14, 0.95) |
| EGFR/ALK mutation Yes No Not tested | 9 52 54 | 11 54 49 | 0.56 (0.05, 6.14) 0.37 (0.15, 0.89) 0.51 (0.21, 1.24) |
Clinical trial identification
NCT02486718.
Editorial acknowledgement
Medical writing support for this abstract was provided by Samantha Santangelo, PhD, of Health Interactions, Inc 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
A. Rittmeyer: Financial Interests, Personal, Advisory Board: AbbVie, AstraZeneca, Boehringer Ingelheim, BMS, Eli Lilly, MSD, Novartis, Pfizer, Roche; Financial Interests, Personal, Invited Speaker: BMS, Eli Lilly, MSD, Novartis, Roche. E. Felip: Financial Interests, Personal, Invited Speaker: Amgen, AstraZeneca, Boehringer Ingelheim, BMS, Lilly, Mirati, Merck, MSD, Novartis, Pfizer, Sanofi, Roche; Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Bayer, Beigene, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Roche, Glaxo Smith Kline, Medical Trends, Peptomyc, Puma Biotechnology, Regeneron, Sanofi, Takeda; Other, Institutional, Research Grant, Research Funding: Oncology Innovation, Merck Healthcare KGAa, Fundacion Merck Salud; Other, Personal, Member, Independent Member of the Board: GRIFOLS. N.K. Altorki: Financial Interests, Personal, Research Grant, Principal Investigator: AstraZeneca, Janssen; Non-Financial Interests, Personal, Other, Steering Committee Member: Roche. E. Vallieres: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Oncocyte; Financial Interests, Personal, Advisory Board: BMS. C. Zhou: Financial Interests, Personal, Invited Speaker: Roche China; Financial Interests, Personal, Other, Speaker: Lily China, BI, Sanofi, C-Stone, Qilu, Hengrui, Innovent Biologics, LUYE Pharma, TopAlliance Bioscience Inc, Amoy Diagnostics. A. Martinez-Marti: Financial Interests, Personal, Advisory Board, Speaker's Bureau: Bristol Myers Squibb, F. Hoffmann La Roche AG, Merck Sharp & Dohme, MSD Oncology, AstraZeneca/MedImmune; Financial Interests, Personal, Other, Speaker's Bureau: Pfizer; Financial Interests, Personal, Invited Speaker, And Local PI: AstraZeneca/MedImmune; Financial Interests, Personal, Invited Speaker: F. Hoffmann La Roche AG, Bristol Myers Squibb, Merck Sharp & Dohme, MSD Oncology; Non-Financial Interests, Personal, Principal Investigator: AstraZeneca/MedImmune, F. Hoffmann La Roche AG, Bristol Myers Squibb, Merck Sharp & Dohme, MSD Oncology. M. Reck: Financial Interests, Personal, Invited Speaker: Amgen, AstraZeneca, Boehringer Ingelheim, BMS, Lilly, MSD, Novartis, Merck, Roche, Sanofi; Financial Interests, Personal, Advisory Board: Mirati, Pfizer, Sanofi, Amgen, AstraZeneca, Boehringer Ingelheim, BMS, MSD, Roche. M.E. Teixeira: Financial Interests, Personal, Advisory Board: AstraZeneca, Roche, Janssen, MSD, Takeda; Financial Interests, Personal, Invited Speaker: AstraZeneca, Janssen, MSD, Boehringer Ingelheim; Financial Interests, Institutional, Research Grant, Research: Roche, Janssen, MSD, Amgen, Boehringer Ingelheim; Financial Interests, Personal, Principal Investigator: Roche, Janssen, MSD, Amgen, Boehringer Ingelheim; Financial Interests, Personal, Other, Consultation: AstraZeneca, Roche, Janssen, Takeda. Y. Deng: Financial Interests, Personal, Full or part-time Employment: Genentech; Financial Interests, Personal, Stocks/Shares: Roche. M. Huang: Financial Interests, Personal, Full or part-time Employment: Genentech; Financial Interests, Personal, Stocks/Shares: Roche. V.A. McNally: Financial Interests, Personal, Full or part-time Employment: Roche; Financial Interests, Personal, Stocks/Shares: Roche. E. Bennett: Financial Interests, Personal, Full or part-time Employment: Genentech; Financial Interests, Personal, Stocks/Shares: Roche. B.J. Gitlitz: Financial Interests, Personal, Full or part-time Employment: Genentech; Financial Interests, Personal, Stocks/Shares: Roche. M. Srivastava: Financial Interests, Personal, Full or part-time Employment: Genentech; Financial Interests, Personal, Stocks/Shares: Roche. H. Wakelee: Financial Interests, Institutional, Research Grant, Research Funding: ACEA Biosciences, Arrys Therapeutics, AstraZeneca/MedImmune, BMS, Celgene, Clovis Oncology, Genentech/Roche, Helsinn, Merck, Novartis, Pharmacyclics, Seagen, Xcovery,; Financial Interests, Personal, Advisory Board: AstraZeneca, Janssen, Daiichi Sankyo, Blueprint, Mirati; Non-Financial Interests, Personal, Advisory Board: Merck, Genentech/Roche; Other, Personal, Leadership Role, President: IASLC; Other, Personal, Leadership Role, Executive Committee: ECOG-ACRIN. All other authors have declared no conflicts of interest.