Abstract 1211P
Background
In IMpower010 (NCT02486718), ctDNA+ status after surgery (post-op) was associated with poor prognosis; atezo was beneficial vs BSC regardless of post-op ctDNA status (Zhou ESMO-IO 2021). Post-chemo, ctDNA clearance (ctDNA−; 62% of post-op ctDNA+ pts) was associated with improved DFS; ctDNA levels were maintained in ctDNA+ pts, and conversion to ctDNA+ was delayed with atezo in ctDNA− pts (Felip ESMO-IO 2022). At final DFS and 2nd IA of overall survival (OS) with ≥5y of follow up, DFS benefit with atezo continued to translate into a positive OS trend vs BSC in PD-L1 tumour cell (TC) ≥1% and TC ≥50% stage II-IIIA pts. We report updated DFS and OS by ctDNA and PD-L1 status.
Methods
Pts with resected (R0) stage IB-IIIA NSCLC and ECOG PS 0-1 who had 1-4 cycles of chemo post-op were randomised 1:1 to atezo 1200 mg Q3W (16 cycles) or BSC. We analysed DFS and OS by ctDNA and PD-L1 (by SP263 IHC) status in post-op ctDNA evaluable pts with stage II-IIIA NSCLC. Plasma samples for ctDNA testing were collected post-op before chemo and post-chemo at Cycle 1 (post-op ctDNA+ pts only) and analysed per the Natera Signatera RUO assay.
Results
Of 1005 randomised pts, 600 were ctDNA evaluable. At data cutoff (26 Jan 2024), 112 of 534 post-op pts (21%) were ctDNA+. DFS and OS outcomes by ctDNA and PD-L1 status are in the table. Median DFS was longer in pts with ctDNA‒ vs ctDNA+ post-op and post-chemo. Longer DFS was seen with atezo vs BSC regardless of ctDNA status. In the post-op PD-L1 TC ≥1% population, a trend toward OS benefit was seen in ctDNA+ and ctDNA‒ pts.
Conclusions
Post-op and post-chemo ctDNA positivity was a negative prognostic factor for DFS after 5y of follow up. Regardless of ctDNA status, DFS and OS benefit with atezo vs BSC was seen in pts with stage II-IIIA PD-L1 TC ≥1% NSCLC. Chemo-mediated ctDNA– was associated with longer DFS. DFS was longer with atezo vs BSC regardless of post-chemo ctDNA status. Table: 1211P
DFS and OS by ctDNA and PD-L1 status in stage II-IIIA ctDNA-evaluable pts
| Group | ctDNA status | PD-L1 status | Median DFS, mo | HR (95%CI) | ||
| Atezo | BSC | |||||
| Post-op | ‒ | All | n=218NE | n=20460.6 | 0.74 (0.56, 0.98) | |
| TC ≥1% | n=124NE | n=9852.6 | 0.60 (0.40, 0.89) | |||
TC Clinical trial identificationNCT02486718. Editorial acknowledgementMedical 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 studyF. Hoffmann-La Roche Ltd. FundingF. Hoffmann-La Roche, Ltd. DisclosureH. 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. 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. 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; Financial Interests, Personal, Invited Speaker: Amgen, Daiichi Sankyo, Genentech, Janssen, Medical Trends, Medscape, Merck Serono, PeerVoice, Pfizer, Sanofi, Takeda, Touch Oncology, 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; 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 Scientific Advisory Committee: CAC Hospital Universitari Parc Taulí. N.K. Altorki: Financial Interests, Institutional, Research Grant, clinical trial: AstraZeneca. E. Vallieres: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Merck, Oncocyte. S. Oizumi: Financial Interests, Personal, Other, Honorarium: AstraZeneca, Chugai Pharmaceutical, MSD. H. Tanaka: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai pharmaceutical, Boehringer Ingelheim, Eli Lilly, MSD, Ono pharmaceutical, Merck, Novartis, Takeda pharmaceutical, Pfizer, Daiichi Sankyo pharmaceutical, Taiho pharmaceutical, Bristol Myers Squibb, EISAI, Hisamitsu pharmaceutical, Nippon Kayaku; Financial Interests, Institutional, Local PI: Chugai pharmaceutical, Merck, AstraZeneca, MSD, Eli Lilly, Ono pharmaceutical, Bristol Myers Squibb, Merck, Takeda pharmaceutical, Taiho pharmaceutical, Pfizer, Daiichi Sankyo pharmaceutical, AbbVie, Amgen, Janssen pharmaceutical. S. McCune: Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb, Genentech; Financial Interests, Institutional, Local PI, Funding for Clinical Trial: Genentech. 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. V.A. McNally: Financial Interests, Personal, Full or part-time Employment: Genentech, Roche; Financial Interests, Personal, Stocks or ownership: Genentech, Roche. S. Novello: Financial Interests, Personal, Invited Speaker: AZ, MSD, Eli Lilly, Novartis, Beigene, Amgen, Thermo Fisher; Financial Interests, Personal, Advisory Board: BI, BMS, Pfizer, Takeda, Roche, Sanofi, Amgen, J&J; Financial Interests, Institutional, Coordinating PI, IIT: MSD, BI; Financial Interests, Institutional, Coordinating PI: AZ, AMG, Eli Lilly, Sanofi, J&J, Roche; Non-Financial Interests, Leadership Role, president of this European advocacy: WALCE; Non-Financial Interests, Member: IASLC, AIOM, ASCO. M. Ballinger: Financial Interests, Personal, Full or part-time Employment: Genentech, Roche; Financial Interests, Personal, Stocks or ownership: Genentech, Roche. W. Zou: Financial Interests, Personal, Full or part-time Employment: Genentech, Roche; Financial Interests, Personal, Stocks or ownership: Genentech, Roche. B. Nabet: 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, Roche; Financial Interests, Personal, Stocks or ownership: Genentech, Roche. C. Zhou: 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. All other authors have declared no conflicts of interest. 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