932MO - Nivolumab (NIVO) plus platinum-doublet chemotherapy (chemo) versus chemo as neoadjuvant treatment for resectable non-small cell lung cancer (NSCLC): Health-related quality of life (HRQoL) outcomes from CheckMate 816

Background

CheckMate 816 (NCT02998528), a phase 3 study, met its primary endpoints of statistically significant and clinically meaningful improvements in event-free survival and pathological complete response with neoadjuvant NIVO + chemo vs chemo for resectable NSCLC. We present HRQoL results from the neoadjuvant treatment period.

Methods

Adults with stage IB-IIIA resectable NSCLC were randomized 1:1 to neoadjuvant NIVO 360 mg + chemo Q3W or chemo Q3W for 3 cycles. HRQoL (exploratory endpoint) was evaluated using the 3-level version of the EQ-5D (EQ-5D-3L). A mixed-effects model repeated measures analysis evaluated longitudinal changes from baseline in EQ-5D visual analogue scale (VAS; range 0 to 100) and utility index (UI; range −0.594 to 1) scores during the neoadjuvant period (week 4, week 7, and post-neoadjuvant visit 1); higher scores reflect better HRQoL.

Results

EQ-5D-3L completion rates were > 80% in both treatment arms at baseline and during the neoadjuvant period. Baseline EQ-5D-3L VAS and UI scores were consistent with UK population norms. Scores during the neoadjuvant period were generally similar to baseline for both treatment arms; there were no clinically meaningful differences between NIVO + chemo vs chemo (Table). In both treatment arms, most patients reported “no problems” for individual EQ-5D-3L dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) at baseline and during treatment. Analyses from the postsurgical period will be presented. Table: 932MO

EQ-5D-3L in the neoadjuvant period

LSM, least squares mean; MID, minimal important difference.

Conclusions

In CheckMate 816, the addition of NIVO to neoadjuvant chemo for resectable NSCLC had no detrimental impact on HRQoL during the neoadjuvant period. These quality of life findings, along with previously reported efficacy and safety results, support the use of NIVO + chemo as neoadjuvant treatment for resectable NSCLC.

Clinical trial identification

NCT02998528.

Editorial acknowledgement

Editorial assistance in the writing of the abstract was provided by Tracy Wetter, PhD, and Michele Salernitano of Ashfield MedComms.

Legal entity responsible for the study

Bristol Myers Squibb.

Funding

Bristol Myers Squibb.

Disclosure

E. Felip: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristrol Meyers Squibb, Eli Lilly, Glaxo Smith Kline, Janssen, Medical Trends, Merck Sharp & Dohme, Pfizer, Puma, Sanofi, Takeda, Merck Serono, Peptomyc, Regeneron, Syneos Health, F. Hoffmann-La Roche; Financial Interests, Personal, Invited Speaker: AstraZeneca, Bristrol Meyers Squibb, Eli Lilly, Medscape, Merck Sharp & Dome, Peervoice, Pfizer, Springer, Touch Medical, Amgen, F. Hoffmann-La Roche, Janssen, Medical Trends, Merck Serono; Financial Interests, Personal, Invited Speaker, Independent member: Grifols; Financial Interests, Institutional, Invited Speaker, Clinical Trial: F. Hoffmann-La Roche Ltd, Merck Sharp & Dohme Corp, AstraZeneca AB, Daiichi Sankyo Inc, Exelixis Inc, Merck KGAA, Janssen Cilag International NV, GlaxoSmithKline Research & Development Limited, AbbVie Deutschland GmbH & Co KG, Novartis Farmaceutica SA, Bayer Consumer Care AG, Takeda Pharmaceuticals International, Boehringer Ingelheim International GmbH, Pfizer S.L.U., Amgen Inc, Bristol-Myers Squibb International Corporation (BMS), Mirati Therapeutics Inc; Non-Financial Interests, Leadership Role, President Elect (2021-2023): SEOM (Sociedad Espanola de Oncologia Medica); Non-Financial Interests, Member, Member of ESMO Nominating Committee and Compliance Committee: ESMO; Non-Financial Interests, Leadership Role, Member of Board of Directors and the Executive Committee (2017-Sept 2021): IASLC (International Association for the Study of Lung Cancer); Non-Financial Interests, Member, Member of Scientific Committee: ETOP (European Thoracic Oncology Platform). T. Ciuleanu: Financial Interests, Personal, Other, speaker, consultancy, advisory role: Roche, BMS, MSD, Pfizer, Eli Lilly, AstraZeneca, Sanofi, Sandoz, Novartis, Janssen, Astellas, Amgen. F. Tanaka: Financial Interests, Personal, Speaker’s Bureau: MSD, Bristol Meyers Squibb, Boehringer Ingelheim, Ono Pharmaceutical, Johnson & Johnson, Covidien Japan, Taiho Pharmaceutical, Eli Lilly, AstraZeneca, Chugai Pharmaceutical.; Financial Interests, Personal, Other, Consultant contractor: AstraZeneca, Bristol Meyers Squibb; Financial Interests, Personal, Funding, Research funding: Boehringer Ingelheim, Ono Pharmaceutical, Taiho Pharmaceutical, Eli Lilly, Chugai Pharmaceutical. N. Girard: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, MSD, Roche, Pfizer, Mirati, Amgen, Novartis, Sanofi; Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Roche, Pfizer, Janssen, Boehringer, Novartis, Sanofi, AbbVie, Amgen, Lilly, Grunenthal, Takeda, Owkin; Financial Interests, Institutional, Research Grant, Local: Roche, Sivan, Janssen; Financial Interests, Institutional, Funding: BMS; Non-Financial Interests, Officer, International Thymic malignancy interest group, president: ITMIG; Other, Family member is an employee: AstraZeneca. S. Lu: Financial Interests, Institutional, Invited Speaker: Hansoh, AstraZeneca, Roche; Financial Interests, Research Grant: AstraZeneca, Hutchison, BMS, Heng Rui BeiGene, Roche, Hansoh. M. Provencio Pulla: Financial Interests, Personal, Advisory Board: BMS, MSD, Bayer, Lilly, Roche, Takeda, Janssen; Non-Financial Interests, Leadership Role, President of Spanish Lung cancer Group: President; Non-Financial Interests, Leadership Role, Insutituto Investigación Sanitaria Puerta de Hierro: Director. T. Mitsudomi: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai, Novartis, MSD, Bristol Myers Squibb, Ono, Pfizer, Eli-Lilly, Merck Biopharma; Financial Interests, Personal, Advisory Board: AsreaZeneca, Boehringer-Ingelheim, Chugai, Novartis, MSD, Bristol Myers Squibb, Ono, Pfiezer, Amgen, Janssen, Takeda, Eli-Lilly; Financial Interests, Institutional, Invited Speaker: Boehringer-Ingelheim, AstraZeneca, Chugai, MSD, Taiho, Daiichi-Sankyo, Ono; Non-Financial Interests, Leadership Role: Interanational Association for Study of Lung Cancer. M. Awad: Financial Interests, Personal, Other, consultant: Genentech, Bristol Myers Squibb, Merck, AstraZeneca, Maverick, Blueprint Medicine, Syndax, Ariad, Nektar, ArcherDX, Mirati, NextCure, Novartis, EMD Serono; Financial Interests, Institutional, Funding, Research funding to institution: AstraZeneca, Eli Lilly, Genentech, Bristol Myers Squibb. P.M. Forde: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, BMS, Daiichi, F-Star, G1, Genentech, Iteos, Janssen, Merck, Novartis, Sanofi, Surface, LUNGevity; Financial Interests, Institutional, Funding, Research funding to institution: AstraZeneca, BioNTech, BMS, Corvus, Kyowa, Novartis, and Regeneron; Financial Interests, Personal, Other, Trial steering committee membership: AstraZeneca, Biontech, BMS, Corvus; Financial Interests, Personal, Member of the Board of Directors: Mesothelioma Applied Research Foundation. R. Lawrance: Financial Interests, Personal, Full or part-time Employment, provide consultancy services for statistical analysis of Patient Reported Outcome Data to pharmaceutical companies: Adelphi Values. F. Taylor: Financial Interests, Personal, Full or part-time Employment, consulting firm receiving payment from BMS (and other pharmaceutical companies) for analysis of clinical trial HRQL data: Adelphi Values. G. Worthy: Financial Interests, Full or part-time Employment, consultancy services for statistical analysis of Patient Reported Outcome Data to pharmaceutical companies: Adelphi Values. S.I. Blum: Financial Interests, Personal, Full or part-time Employment, Full-time Employee of Bristol Myers Squibb: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares, Stock shareholder of Bristol Myers Squibb: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares, Stock shareholder of GlaxoSmithKline: GlaxoSmithKline. L. Vo: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. J.L. Cai: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. J. Spicer: Financial Interests, Personal, Invited Speaker, speaker, consultancy, advisory role: Merck, BMS, Roche, AstraZeneca, Protalix Biotherapeutics, Chemocentryx; Financial Interests, Personal, Funding, Research funding: Merck, Roche, Protalix Biotherapeutics, CLS Therapeutics; Non-Financial Interests, Personal, Proprietary Information: AstraZeneca, Protalix Biotherapeutics, CLS Therapeutics. All other authors have declared no conflicts of interest.