Abstract 138P
Background
CheckMate 77 T demonstrated statistically significant and clinically meaningful improvement in EFS for NIVO vs placebo (PBO) in pts with resectable NSCLC; pCR was also improved. Here, we report clinical and pt-reported outcomes by tx cyc.
Methods
Pts with resectable stage IIA–IIIB NSCLC were randomized 1:1 to neoadjuvant (neoadj) NIVO + chemotherapy (chemo) Q3W (up to 4 cyc) followed by adj NIVO Q4W (up to 13 cyc) or neoadj PBO + chemo Q3W (up to 4 cyc) followed by adj PBO Q4W (up to 13 cyc). Exploratory analyses included EFS, onset of AEs by neoadj and adj tx cyc, and FACT-L GP5 (pt-reported bother by tx-related AEs [TRAEs]).
Results
Of 461 randomized pts (median f/u 33.3 mo), 139 (61%; NIVO) and 149 (64%; PBO) received ≥1 cyc of adj tx; 87 (38%) and 95 (41%), respectively, completed 13 adj tx cyc. Baseline characteristics were similar across tx arms for pts who completed 13 or
Conclusions
In this exploratory analysis, NIVO improved EFS vs PBO in pts with resectable NSCLC whether they completed 13 cyc of adj NIVO or not. Tx with adj NIVO had no negative impact on tolerability and did not increase bother by TRAEs. These results reinforce perioperative NIVO as a tx option for resectable NSCLC.
Editorial acknowledgement
Medical writing and editorial support for the development of this abstract, under the direction of the authors, was provided by Sara Thier, PhD, MPH, and Michele Salernitano of Ashfield MedComms, an Inizio company, and funded by Bristol Myers Squibb.
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
D. Moro-Sibilot: Financial Interests, Personal, Advisory Board: Lilly, Roche, BMS, MSD, AbbVie, Becton Dickinson, Pfizer, Takeda, AstraZeneca, Boehringer Ingelheim, Novartis, GSK, Sanof; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Institutional, Funding, IFCT clinical trials: Pfizer; Financial Interests, Institutional, Funding: Roche, AbbVie, AstraZeneca. T. Cascone: Financial Interests, Personal, Invited Speaker, Speaker Fees/Honoraria, Advisory role, Research Funding: AstraZeneca; Financial Interests, Personal, Invited Speaker, Speaker Fees/Honorarium, Advisory Role, Research Funding: Bristol Myers Squibb; Financial Interests, Personal, Invited Speaker, Speaker Fee: Clinical Care Options; Financial Interests, Personal, Invited Speaker, Speaker Fees/Honorarium: IDEOlogy Health, PeerView, Physician’s Education Resource; Financial Interests, Personal, Invited Speaker, Speaker Fee/Panelist Honorarium: Medscape; Financial Interests, Personal, Invited Speaker, Speaker Fees/Panelist Honoraria: OncLive; Financial Interests, Personal, Advisory Board, Advisory Board Fee: Merck, Regeneron; Financial Interests, Personal, Advisory Board, Advisory Board Fees: Pfizer; Financial Interests, Personal, Advisory Board, Speaker Fees/Honorarium: ASCO Post, Bio Ascend; Financial Interests, Personal, Advisory Board, Speaker Fees/Honoraria: Medical Educator Consortium, Targeted Oncology; Financial Interests, Personal, Advisory Board, Advisory/Consulting: Daiichi Sankyo; Financial Interests, Personal, Advisory Board, advisory role/consulting: Genentech, oNKo-Innate, Rapt Therapeutics, Summit Therapeutics; Financial Interests, Personal, Other, Travel Expenses For Conferences as Invited Speaker: ESMO; Financial Interests, Personal, Other, Speaker Fee and Travel Expenses For Conferences as Invited Speaker: SITC; Financial Interests, Personal, Other, Travel/Food/Beverage Expenses For Conferences as Invited Speaker: IASLC; Financial Interests, Personal, Other, Travel/Food/Beverage Expenses for Meeting as Invited Panelist: AATS; Financial Interests, Personal, Other, Travel/Food/Beverage Expenses for Conference as Invited Speaker: Dava Oncology; Financial Interests, Institutional, Invited Speaker, Institutional Clinical Research Funding: AstraZeneca, Bristol Myers Squibb; Financial Interests, Institutional, Research Grant, Institutional Research Grant Funding: Bristol Myers Squibb; Financial Interests, Personal and Institutional, Invited Speaker, Clinical Research: AstraZeneca; Non-Financial Interests, Personal, Leadership Role, The Leading Edge of Cancer Research Symposium Co-chair and Chair (2021 and 2022)Co-Chair, Data and Biospecimen Access Committee (DBAC), 2022 – present: The University of Texas MD Anderson Cancer Center; Non-Financial Interests, Personal, Leadership Role, Co-Chair, Neoadjuvant Immunotherapy Session, 36th SITC Annual Meeting, 11/2021: SITC; Non-Financial Interests, Personal, Leadership Role, Co-Chair, Texas Lung Cancer Conference 2023, and 2024. Austin, TX 4/2023 and 4/2024.: IDEOlogy Health; Non-Financial Interests, Personal, Leadership Role, Co-Chair, The Future of immunotherapy in Thoracic Oncology, Educational Session, ESMO Immuno-Oncology Congress, Geneva, Switzerland, 12/6/2023: ESMO; Non-Financial Interests, Personal, Leadership Role, Co-Chair, Lung Cancer Summit Post-ESMO Congress 2023, sponsored by AstraZeneca, Madrid, Spain 10/24-10/25/2023: AstraZeneca; Non-Financial Interests, Personal, Leadership Role, Chair, Early-Stage NSCLC Session. IASLC Targeted Therapies of Lung Cancer Meeting (TTLC) 2021, Santa Monica, CA, 2/2021Chair, IASLC 2022 World Conference on Lung Cancer, Neoadjuvant and Adjuvant Treatment of NSCLC Session, Vienna, Austria, 8/2022Chair, IASLC 2022World Conference on Lung Cancer, Immune Landscape and Molecular Profiling of Lung Cancer Session, Vienna, Austria, 8/2022Chair, IASLC 2023 World Conference on Lung Cancer, Pushing the Boundaries: Adjuvant and Neoadjuvant Approaches in Early-Stage Non-small Cell Lung Cancer, Singapore 9/2023: IASLC; Non-Financial Interests, Personal, Member: ESMO, ASCO, AACR, SITC, IASLC. M. Awad: Financial Interests, Personal, Advisory Board: Merck, Bristol Myers Squibb, Genentech, AstraZeneca, AbbVie, Gritstone, Synthekine, Mirati, Regeneron, Affini-T, EMD Serono, Novartis, Janssen, Coherus; Financial Interests, Institutional, Funding: Bristol Myers Squibb, Lilly, Genentech, AstraZeneca, Amgen. J. Spicer: Financial Interests, Personal, Research Grant: AstraZeneca, Bristol Myers Squibb, CLS Therapeutics, Protalix Biotherapeutics, Merck, Roche; Financial Interests, Personal, Other, consulting fees: Roche, Merck, Bristol Myers Squibb, AstraZeneca, Regeneron, Protalix Biotherapeutics, Xenetic Biosciences, Amgen, Novartis; Financial Interests, Personal, Speaker’s Bureau: PeerView, Bristol Myers Squibb, AstraZeneca; Non-Financial Interests, Personal, Advisory Board: PUCC Trial; Non-Financial Interests, Personal, Leadership Role: Canadian Association of Thoracic Surgeons. F. Tanaka: Financial Interests, Personal, Research Grant: Ono Pharmaceutical, Taiho Pharmaceutical, Lilly Japan, Chugai Pharmaceutical; Financial Interests, Personal, Other, consulting fees: AstraZeneca, Chugai Pharmaceutical, Ono Pharmaceutical, Bristol Myers Squibb; Financial Interests, Personal, Speaker’s Bureau: MSD, Bristol Myers Squibb, Boehringer Ingelheim Japan, Ono Pharmaceutical, Johnson & Johnson, Covidien Japan, Taiho Pharmaceutical, Lilly Japan, AstraZeneca, Chugai Pharmaceutical, Kyowa-Kirin, Takeda Pharmaceutical, Pfizer, Olympus, Stryker, Intuitive Japan. S. Lu: Financial Interests, Personal, Research Grant: AstraZeneca, Hutchison, Bristol Myers Squibb, Heng Rui, BeiGene, Roche, Hansoh; Financial Interests, Personal, Other, consulting fees: AstraZeneca, Hutchison, Roche, Simcere; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Roche, Hansoh, Hengrui Therapeutics; Financial Interests, Personal, Advisory Board: Roche, Hengrui Therapeutics, Daiichi Sankyo; Financial Interests, Personal, Member of Board of Directors, Independent Director: BIOLOGICS, INC. L.D.O. Koch: Non-Financial Interests, Personal, Principal Investigator, Checkmate 77T: Bristol. A. Janssens: Financial Interests, Personal, Research Grant: Stichting tegen Kanker; Financial Interests, Personal, Other, consulting fees: AstraZeneca, Bristol Myers Squibb, MSD; Financial Interests, Personal, Other, Institutional honoraria: AstraZeneca, Bristol Myers Squibb, MSD; Financial Interests, Personal, Other, Support for attending meetings and/or travel: AstraZeneca, Bristol Myers Squibb, MSD; Financial Interests, Personal, Advisory Board: MSD, Johnson & Johnson, Bristol Myers Squibb; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo. A. Alexandru: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Sanofi; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Magna Pharm, Labormed Pharma; Financial Interests, Personal, Other, Support for attending meetings and/or travel4: Merck; Financial Interests, Personal, Advisory Board: Roche. S. Bohnet: Financial Interests, Personal, Research Grant: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Local Advisory Board Germany. C.M. Bestvina: Financial Interests, Personal, Research Grant: AstraZeneca, Bristol Myers Squibb; Financial Interests, Personal, Other, consulting fees: AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, EMD Serono, Genentech, Gilead, Guarant, Johnson & Johnson, Mirati, Novocure, Pfizer, Tempus, Turning Point Therapeutics; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Guarant; Financial Interests, Personal, Invited Speaker, Support for attending meetings and/or travel: Johnson & Johnson. S. Bhatia: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Bristol Myers Squibb. C. Coronado Erdmann: Financial Interests, Personal, Full or part-time Employment, Sr Clinical Trial Physician: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. S.I. Blum, S. Lucherini: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. M. Provencio Pulla: Financial Interests, Personal, Advisory Board: BMS, MSD, Bayer, Lilly, Roche, Takeda, Janssen, Daiichi Sankyo, Johnson & Johnson, Gilead, Guardant Health, Ipsen, Incyte Biosciences, Bayer; Financial Interests, Personal, Other, Consulting, support for attending meetings and/or travel, honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: BMS, AstraZeneca, MSD, Roche, Takeda, Eli Lilly, F. Hoffman-La Roche, Janssen, Pfizer, Amgen, Boehringer Ingelheim, Pierre Fabre Pharmaceuticals; Financial Interests, Institutional, Invited Speaker: AstraZeneca, BMS, Takeda, MSD, Roche, Pfizer, Amgen; Non-Financial Interests, Personal, Leadership Role, President: Spanish Lung cancer Group, Grupo Oncológico para el Tratamiento de las Enfermedades Linfoides; Non-Financial Interests, Personal, Leadership Role, Scientific Director: Instituto Investigación Sanitaria Puerta de Hierro. All other authors have declared no conflicts of interest.