1212P - IMpower010: Characterisation of patients (pts) with stage II-IIIA PD-L1 TC≥50% NSCLC who were disease-free at 5 years (5yDF) in a phase III study of atezolizumab (atezo) vs best supportive care (BSC) after resection and adjuvant (adj) chemotherapy (chemo)

Background

IMpower010 showed significantly improved DFS with atezo vs BSC after adj chemo in resected NSCLC (Felip Lancet 2021), leading to global approval of adj atezo for stage II-IIIA NSCLC with PD-L1 TC ≥1% or ≥50%. With ≥5 y of follow-up, the DFS benefit continued to translate into a clinically meaningful OS trend in the stage II-IIIA TC ≥50% population (pop). We report an exploratory analysis in this pop, including OS subgroup data, and characterisation of pts who were 5yDF.

Methods

1280 pts with resected stage IB-IIIA NSCLC and ECOG PS 0/1 received 1-4 chemo cycles after surgery; 1005 were randomised 1:1 to atezo 1200 mg Q3W (16 cycles) or BSC. This analysis (clinical cutoff: 26 Jan 2024) was in the stage II-IIIA NSCLC with TC ≥50% (negative or unknown EGFR/ALK status) pop. 5yDF described pts with no disease recurrence or who had not died ≥5 y from randomisation.

Results

In the stage II-IIIA PD-L1 TC ≥50% pop (n=209), OS benefit was seen with atezo vs BSC across key subgroups, regardless of histology, nodal involvement and disease stage. After censored pts were excluded, 169 pts were evaluated for 5y DFS (atezo: n=81; BSC: n=88). Among 5yDF-evaluable pts, baseline characteristics were generally balanced between treatment (tx) arms. More pts were 5yDF with atezo (n=48 [59.3%]; 95% CI: 47.8, 70.1) vs BSC (n=35 [39.8%]; 95% CI: 29.5, 50.8). Subgroups with >15% difference in 5yDF rate between tx arms included age, sex, ECOG PS 0, stage IIIA, N1, N2 and non-squamous histology (Table). Table: 1212P

5yDF rates in key subgroups of the stage II-IIIA PD-L1 TC ≥50% pop

ctDNA, circulating tumour DNA; ECOG PS, Eastern Cooperative Oncology Group performance status; TMB, tumour mutation burden.

Conclusions

While the sample size was small, these exploratory data show that more pts were 5yDF with atezo vs BSC across key subgroups, suggesting a benefit with atezo regardless of baseline characteristics, including in pts with adverse baseline prognostic features such as stage IIIA, N1 or N2 disease, and post-op ctDNA positivity.

Clinical trial identification

NCT02486718.

Editorial acknowledgement

Medical writing assistance for this manuscript was provided by Bena Lim, PhD, CMPP, of Nucleus Global, an Inizio Company, and funded by F. Hoffmann-La Roche Ltd.

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.

Funding

F. Hoffman-La Roche Ltd.

Disclosure

E. Felip: Financial Interests, Personal, Advisory Board: AbbVie, Amgen, AstraZeneca, Bayer, Beigene, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Gilead, GSK, Janssen, Merck Serono, Merck Sharp & Dohme, Novartis, Peptomyc, Regeneron, Sanofi, Takeda, Turning Point, Pfizer, Genmab; Financial Interests, Personal, Invited Speaker: Amgen, Daiichi Sankyo, Genentech, Janssen, Medical Trends, Medscape, Merck Serono, PeerVoice, Pfizer, Sanofi, Takeda, AstraZeneca, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Merck Sharp & Dohme; Financial Interests, Personal, Member of Board of Directors, Independent member: Grifols; Financial Interests, Institutional, Local PI, Clinical Trial: AstraZeneca AB, AbbVie, Amgen, Bayer Consumer Care AG, Beigene, Boehringer Ingelheim GmbH, Bristol Myers Squibb International Corporation, Daiichi Sankyo Inc., Exelixis Inc., F. Hoffmann-La Roche Ltd., Genentech Inc., GSK Research and Development Limited, Janssen Cilag International NV, Merck Sharp & Dohme Corp, Merck KGAA, Mirati Therapeutics Inc, Novartis Pharmaceutica SA, Pfizer, Takeda Pharmaceuticals International; Financial Interests, Institutional, Local PI: Nuvalent; Non-Financial Interests, Leadership Role, President (2021-2023): SEOM (Sociedad Espanola de Oncologia Medica); Non-Financial Interests, Member, Member of Scientific Committee: ETOP (European Thoracic Oncology Platform); Non-Financial Interests, Member, Member of the Scientiffic Advisory Committee: CAC Hospital Universitari Parc Taulí. E. Vallieres: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Merck, Oncocyte. 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, Advisory Board: Amgen; Financial Interests, Personal, Steering Committee Member, And Local PI: AstraZeneca/MedImmune; Financial Interests, Personal, Local PI: F. Hoffmann La Roche AG, Bristol Myers Squibb, Merck Sharp & Dohme, MSD Oncology; Non-Financial Interests, Principal Investigator: AstraZeneca/MedImmune, F. Hoffmann La Roche AG, Bristol Myers Squibb, Merck Sharp & Dohme, MSD Oncology. C. Zhou: Financial Interests, Personal, Invited Speaker, speaking fee, advisory role.: Eli Lily; Financial Interests, Personal, Invited Speaker, honoraria as a speaker.: Roche, Sanofi, Boehringer Ingelheim, MSD, C-Stone; Financial Interests, Personal, Invited Speaker, Speaking fee, advisory role.: Qilu Pharma; Financial Interests, Personal, Invited Speaker, honoraria as a speaker, advisor.: Hengrui, Innovent Biologics, TopAlliance Biosciences Inc; Financial Interests, Personal, Invited Speaker, honoraria as a speaker: LUYE Pharma; Financial Interests, Personal, Advisory Board, Advisor: Amoy Diagnositics; Financial Interests, Personal, Other, honoraria as a speaker: Alice; Financial Interests, Personal, Other, honoraria as a speaker from AnHeart.: AnHeart. N.K. Altorki: Financial Interests, Institutional, Research Grant, clinical trial: AstraZeneca. A. Rittmeyer: Financial Interests, Personal, Advisory Board: AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Daiichi Sankyo, Gilead, GSK, MSD, Eli Lilly, Novartis, Pfizer, Roche. M. Reck: Financial Interests, Personal, Invited Speaker: Amgen, AstraZeneca, BMS, Boehringer Ingelheim, Lilly, MSD, Merck, Novartis, Regeneron, Roche, Sanofi, GSK, Pfizer; Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, BMS, Biontech, Boehringer Ingelheim, Daiichi Sankyo, Gilead, MSD, Mirati, Pfizer, Regeneron, Roche, Sanofi, GSK, Lilly; Financial Interests, Personal, Other, Member of DMSB: Daiichi Sankyo; Financial Interests, Personal, Coordinating PI: AstraZeneca; Financial Interests, Institutional, Steering Committee Member: Amgen, Boehringer Ingelheim, Beigene, Daiichi Sankyo, GSK, BMS, Lilly, MSD, Regeneron, Roche; Financial Interests, Institutional, Local PI: Pfizer Seagen. W. Schütte: Financial Interests, Personal, Other, Research grants, investigator fees, honoraria, speakers fees: Lilly, Merck, AstraZeneca, Roche, Boehringer Ingelheim. M. Okada: Financial Interests, Personal, Other, honoraria: Johnson & Johnson K.K., AstraZeneca K.K., Ono Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., CSL Behring K.K., Bristol Myers Squibb K.K.; Financial Interests, Institutional, Research Funding: Chugai Pharmaceutical Co., Ltd., Bristol Myers Squibb K.K., AstraZeneca K.K.. E. Bennett: Financial Interests, Personal, Full or part-time Employment: Genentech, Roche; Financial Interests, Personal, Stocks or ownership: Genentech, Roche. B.J. Gitlitz: Financial Interests, Personal, Full or part-time Employment: Genentech, Roche; Financial Interests, Personal, Stocks or ownership: Genentech, Roche. M. Srivastava: Financial Interests, Personal, Full or part-time Employment: Genentech/Roche; Financial Interests, Personal, Stocks or ownership: Genentech/Roche. M. Ballinger: Financial Interests, Personal, Full or part-time Employment: Genentech, Roche; Financial Interests, Personal, Stocks or ownership: Genentech, Roche. C. Zhu: Financial Interests, Personal, Advisory role, Consulting fees: Innovent Biologics, Qilu, Hengrui, TopAlliance Biosciences Inc.; Financial Interests, Personal, Other, Payment or honoraria from: Eli Lilly China, Sanofi, Boehringer Ingelheim, Roche, Merck Sharp & Dohme, Qilu, Hengrui, Innovent Biologics, Alice, C-Stone, LUYE Pharma, TopAlliance Biosciences Inc., Amoy Diagnostics, AnHeart. L. Crama: Financial Interests, Personal, Full or part-time Employment, I am full time employee for Roche Farma SA., Madrid, Spain.: Roche Farma SA., Madrid, Spain; Financial Interests, Personal, Stocks/Shares: Hoffmann-La Roche Ltd.. H. Wakelee: Financial Interests, Personal, Advisory Board, Served on a DSMC, completed November 2022: Mirati; Financial Interests, Personal, Invited Speaker, Develop and present a series of lectures: Fishawack Facilitate LTD; Financial Interests, Personal, Invited Speaker, Series of CME lectures: Medscape, Research to Practice; Financial Interests, Personal, Other, Discussion of new data at conferences: Curio Science; Financial Interests, Personal, Invited Speaker, Series of lectures/webinars for PER/OncLive: MJH Holdings; Financial Interests, Personal, Invited Speaker, CME lecture: Axis Medical Education, ParadigmMC, Prova Education; Financial Interests, Personal, Advisory Board: IOBiotech; Financial Interests, Personal, Invited Speaker, Facilitated speaking at several virtual conferences: Shanghai Bird Translation and Consulting; Financial Interests, Personal, Invited Speaker, Invited speaker at virtual symposium: China International Medical Foundation; Financial Interests, Personal, Invited Speaker, Invited to speak and moderate at JLCS meetings: Japanese Lung Cancer Society; Financial Interests, Personal, Invited Speaker, Presented at several CME conferences: Medical Educator Consortium; Financial Interests, Personal, Invited Speaker, Facilitated discussion of recent data: IDEOlogy Health; Financial Interests, Personal, Invited Speaker, Invited CME lecture: Vindico Medical Education; Financial Interests, Personal, Invited Speaker, Invited speaker at symposium: Taiwan Association for the Study of Lung Cancer (TASLC); Financial Interests, Personal, Royalties, I receive royalties for a chapter I wrote for UpToDate: UpToDate; Financial Interests, Institutional, Local PI, Clinical Trial Conduct: AstraZeneca/MedImmune, BMS, Seagen, Xcovery; Financial Interests, Institutional, Steering Committee Member, Clinical Trial Conduct: Genentech/Roche, Merck; Financial Interests, Institutional, Local PI, clinical trial conduct: Helsinn; Financial Interests, Institutional, Coordinating PI, IIT for single site: Bayer; Financial Interests, Personal, Steering Committee Member, uncompensated steering committee member: Merck, AstraZeneca, Genentech/Roche; Financial Interests, Personal, Other, uncompensated advisory board participation: BMS; Non-Financial Interests, Officer, Past President: International Association for the Study of Lung Cancer (IASLC); Non-Financial Interests, Leadership Role, Executive Committee: ECOG-ACRIN. All other authors have declared no conflicts of interest.