Abstract 80O
Background
IMpower010 showed significant DFS benefit with atezo after adjuvant chemo in resected NSCLC (Felip Lancet 2021). At the interim DFS analysis, the significance boundary was crossed for the stage II-IIIA PD-L1 TC ≥1% population (stratified HR, 0.66; 95% CI: 0.50, 0.88), with greatest benefit in the PD-L1 TC ≥50% subgroup (unstratified HR, 0.43; 95% CI: 0.27, 0.68). Here we present further analyses in PD-L1 TC ≥50% stage II-IIIA NSCLC pts.
Methods
IMpower010 (NCT02486718) study design and primary DFS analysis details have been reported (Felip Lancet 2021). DFS in PD-L1 TC ≥50% (VENTANA SP263 assay) stage II-IIIA (UICC/AJCC v7) pts was a prespecified secondary endpoint; additional subgroup data reported are exploratory.
Results
Baseline characteristics were generally balanced for atezo- vs BSC-arm pts with PD-L1 TC ≥50% stage II-IIIA NSCLC (male, 77% vs 68%; stage III, 46% vs 50%; nonsquamous, 59% vs 61%). Median follow-up was 34.2 mo (21 Jan 2021 cutoff). See the table for DFS subgroup data. Safety in PD-L1 TC ≥50% stage II-IIIA pts was consistent with that of the overall study population and known safety profile of atezo. Initial disease relapse in this population was locoregional-only in 15/25 atezo-arm pts (60%) vs 17/50 BSC-arm pts (34%) and distant-only in 6/25 (24%) vs 21/50 (42%); initial CNS-only relapse was seen in 1/25 (4%) vs 7/50 (14%). 19 relapsing atezo-arm pts (76%) vs 30 BSC-arm pts (60%) had subsequent systemic therapy (mostly chemo, 60% vs 32%; immunotherapy, 16% vs 38%).
Conclusions
IMpower010 pts with PD-L1 TC ≥50% stage II-IIIA NSCLC derived DFS benefit with atezo vs BSC at the interim DFS analysis. Data were consistent across most subgroups, albeit with limited pt numbers in this post hoc analysis. Numerically, more distant and CNS relapses were seen with BSC. The tolerability profile of atezo was in line with the overall population, demonstrating a positive benefit-risk profile. Table: 80O
Interim DFS: PD-L1 TC ≥50% stage II-IIIA
| Pts, n | Unstratified DFS HR (95% CI) | |||
| Atezo | BSC | |||
| Age <65 y ≥65 y | 71 44 | 70 44 | 0.49 (0.27, 0.89) 0.36 (0.17, 0.75) | |
| Sex Male Female | 89 26 | 78 36 | 0.50 (0.28, 0.89) 0.34 (0.15, 0.76) | |
| Histology Squamous Nonsquamous | 47 68 | 45 69 | 0.60 (0.29, 1.26) 0.36 (0.20, 0.65) | |
| Stage II IIIA | 62 53 | 57 57 | 0.51 (0.26, 1.00) 0.38 (0.20, 0.72) | |
| Regional LN N0 N1 N2 | 30 43 42 | 21 52 41 | 1.09 (0.39, 3.07) 0.29 (0.12, 0.72) 0.35 (0.18, 0.68) | |
| Smoking status Current/former Never | 99 16 | 99 15 | 0.40 (0.24, 0.68) 0.46 (0.17, 1.25) | |
| EGFR/ALK mutation Detected Undetected Unknown | 9 52 54 | 11 54 49 | 0.26 (0.06, 1.02) 0.41 (0.20, 0.84) 0.45 (0.23, 0.91) |
DFS event/pts: atezo, 28/115 (24%); BSC, 52/114 (46%).
Clinical trial identification
NCT02486718.
Editorial acknowledgement
Medical writing assistance for this abstract was provided by Ashley J Pratt, 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
E. Felip: Other, Personal, Invited Speaker: Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Roche, Janssen, MSD, Merck Serono, Pfizer, PeerVoice, Springer, Touch Medical; Other, Personal, Advisory Board: Amgen, AstraZeneca, Bayer, Beigene, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Roche, GlaxoSmithKline, Medical Trends, Peptomyc, Puma Biotechnology, Regeneron, Sanofi, Takeda, Janssen, MSD, Merck Serono, Pfizer; Other, Institutional, Research Grant, Research Funding: Oncology Innovation, Merck Healthcare KGAa, Fundacion Merck Salud; Other, Personal, Member of the Board of Directors, Independent Member of the Board: GRIFOLS. N.K. Altorki: Financial Interests, Institutional, Research Grant: AstraZeneca, Janssen, NCI, DoD. C. Zhou: Financial Interests, Personal, Invited Speaker: Roche China, Lily China, BI, Sanofi, C-Stone, Qilu, Hengrui, Innovent Biologics, LUYE Pharma, TopAlliance Bioscience Inc, Amoy Diagnostics. A. Martinez-Marti: Financial Interests, Personal, Speaker’s Bureau: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Roche, Merck, Pfizer, MSD Oncology, AstraZeneca; Financial Interests, Personal, Other, Personal Fees and Travel Expenses outside the submitted work: Bristol Myers Squibb, Roche, MSD, Pfizer, Boehringer Ingelheim, MSD Oncology, AstraZeneca. N. Kislov: Financial Interests, Personal and Institutional, Principal Investigator: AstraZeneca, Eisai, EMD Serono, Exelixis, MSD, Genentech/Roche, GlaxoSmithKlein, Ipsen Novartis, Pfizer, Nektar, Lilly; Financial Interests, Personal, Invited Speaker: Biocad, Ipsen, Roche. R. Belleli: Financial Interests, Personal, Full or part-time Employment: Roche; 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/Roche; Financial Interests, Personal, Stocks/Shares: Roche. B.J. Gitlitz: Financial Interests, Personal, Full or part-time Employment: Genentech/Roche; Financial Interests, Personal, Stocks/Shares: Roche. H. Wakelee: Financial Interests, Institutional, Research Grant: ACEA Biosciences, Arrys Therapeutics, AstraZeneca/MedImmune, Bristol Myers Squibb, Celgene, Clovis Oncology, Genentech/Roche, Helsinn, Merck, Novartis, Pharmacyclics, Seagen, Xcovery; Financial Interests, Personal, Advisory Role, Consulting: AstraZeneca, Blueprint, Mirati. All other authors have declared no conflicts of interest.