Abstract 121P
Background
CheckMate 77T (NCT04025879) demonstrated statistically significant and clinically meaningful improvement in event-free survival for perioperative NIVO added to neoadjuvant (neoadj) chemo (NIVO+chemo/NIVO) vs perioperative placebo added to neoadj chemo (chemo/PBO) in patients (pts) with resectable NSCLC. Here we report HRQoL results.
Methods
Adults with untreated, resectable stage IIA-IIIB NSCLC were randomized 1:1 to NIVO 360 mg Q3W + chemo (4 cycles) followed by surgery and adjuvant (adj) NIVO 480 mg Q4W (1 y), or PBO Q3W + chemo (4 cycles) followed by surgery and adj PBO Q4W (1 y). Pt-reported outcome (PRO) measures included NSCLC-SAQ, FACT-L, EQ-5D-3L, and PROMIS Physical Function Short-Form 8c. The assessment schedule was the same in both treatment (tx) arms. Changes from baseline (BL) were analyzed using a mixed model for repeated measures. Time to definitive deterioration (TTDD) was defined as time from randomization to worsening from BL with no subsequent improvement.
Results
Completion rates for all PRO measures were mostly > 90%, except at pre- and postsurgical visits. BL scores indicated good HRQoL for pts in both tx arms. Pts generally maintained their HRQoL during tx, except at the postsurgical visit. Least squares mean change (95% CI) from BL over the on-tx period for NSCLC-SAQ was 0.26 (−0.06 to 0.58) in the NIVO+chemo/NIVO arm and 0.33 (0.02 to 0.65) in the chemo/PBO arm and ranged from −0.51 to 1.71 and −0.76 to 1.43, respectively. Pts treated with NIVO+chemo/NIVO had delayed median TTDD vs those treated with chemo/PBO (NSCLC-SAQ HR 0.66 [95% CI 0.45–0.98]; results in table).
Table: 121P
TTDD in all randomized pts
| Scale | Median TTDDa, mo (95% CI) | HR (95% CI) | |
| NIVO+chemo/NIVO n = 229 | Chemo/PBO n = 232 | ||
| NSCLC-SAQb | 40.0 (33.6–NR) | 31.1 (25.0–NR) | 0.66 (0.45–0.98) |
| FACT-L LCSc | 32.7 (27.2–NR) | 27.5 (20.2–NR) | 0.69 (0.49–0.97) |
| EQ-5D-3L UId | 31.3 (25.8–NR) | 26.6 (20.9–NR) | 0.82 (0.60–1.12) |
| EQ-5D-3L VASe | NR (36.6–NR) | NR (22.8–NR) | 0.67 (0.47–0.96) |
aTTDD was assessed during tx and follow-up. RD of ≥ b+3, c−3, d−0.08, and e−7 point changes from BL. FACT-L, Functional Assessment of Cancer Therapy - Lung; LCS, Lung Cancer Subscale; NR, not reached; NSCLC-SAQ, NSCLC Symptom Assessment Questionnaire; RD, responder definition; UI, utility index; VAS, visual analogue scale.
Conclusions
In CheckMate 77T, perioperative NIVO did not adversely impact HRQoL during the tx period and reduced the risk of definitive deterioration vs chemo/PBO. These findings, along with previously reported efficacy and safety results, support perioperative NIVO as a potential tx option for pts with resectable NSCLC.
Clinical trial identification
NCT04025879 (release date: July 17, 2019).
Editorial acknowledgement
Medical writing and editorial support for the development of this abstract, under the direction of the authors, was provided by Sabrina Hom, PhD, Samantha Dwyer, PhD, and Michele Salernitano of Ashfield MedComms, an Inizio company.
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
J. Spicer: Financial Interests, Personal, Advisory Board: AstraZeneca, Merck, Roche, BMS, Novartis, Amgen, Protalix Biotherapeutics, Xenetic Biosciences, Regeneron, Eisai; Financial Interests, Personal, Invited Speaker: AstraZeneca, Merck, BMS; Financial Interests, Institutional, Invited Speaker, In kind contribution of investigational drug.: AstraZeneca, BMS; Financial Interests, Institutional, Invited Speaker, Grant to institution for research within my laboratory.: CLS Therapeutics; Financial Interests, Institutional, Invited Speaker, Grant to institution for execution of research within my laboratory.: Protalix Biotherapeutics; Financial Interests, Institutional, Invited Speaker, Grant to institution for execution of multi-center clinical trial.: Roche; Financial Interests, Institutional, Invited Speaker, Grant to institution for execution of clinical trial.: Merck; Non-Financial Interests, Personal, Principal Investigator, Clinical trial chair for IND 242 Neoadjuvant Platform Trial in Patients with Surgically Resectable Non-Small Cell Lung Cancer (NSCLC): Canadian Cancer Trials Group. M. Provencio Pulla: Financial Interests, Personal, Advisory Board: BMS, MSD, Bayer, Lilly, Roche, Takeda, Janssen; Non-Financial Interests, Personal, Leadership Role, President of Spanish Lung cancer Group: President; Non-Financial Interests, Personal, Leadership Role, Insutituto Investigación Sanitaria Puerta de Hierro: Director. M. Awad: Financial Interests, Personal, Other, Consultant: Genentech, Bristol Myers Squibb, Merck, AstraZeneca, Maverick, Blueprint Medicines, Syndax, Ariad, Nektar, ArcherDX, Mirati, NextCure, Novartis, EMD Serono; Financial Interests, Institutional, Research Grant: AstraZeneca, Lilly, Genentech, Bristol Myers Squibb. S. Lu: Financial Interests, Institutional, Invited Speaker: Hansoh, AstraZeneca, Roche, Hengrui; Financial Interests, Institutional, Advisory Board: AstraZeneca, Pfizer, Boehringer Ingelheim, Hutchison MediPharma, ZaiLab, GenomiCare, Yuhan Corporation, Menarini, InventisBio Co.Ltd, Roche, Simcere Zaiming Pharmaceutical Co., Ltd.; Financial Interests, Personal, Research Grant: AstraZeneca, Hutchison, BMS, Heng Rui, Roche, Hansoh, BeiGene, Lilly Suzhou Pharmaceutical Co.Ltd; Financial Interests, Personal, Invited Speaker: FibroGen. F. Tanaka: Financial Interests, Institutional, Research Grant: Boehringer Ingelheim Japan, Ono Pharmaceutical, Taiho Pharmaceutical, Eli Lilly Japan, Chugai Pharmaceutical; Financial Interests, Personal, Other, Consultant: AstraZeneca, Chugai Pharmaceutical, Ono Pharmaceutical; Financial Interests, Personal, Speaker’s Bureau: MSD, Bristol Myers Squibb, Boehringer Ingelheim Japan, Ono Pharmaceutical, Johnson & Johnson, Covidien Japan, Taiho Pharmaceutical, Eli Lilly Japan, AstraZeneca, Chugai Pharmaceutical, Kyowa Kirin, Takeda Pharmaceutical, Pfizer, Olympus, Stryker, Intuitive Japan. R. Cornelissen: Financial Interests, Personal, Other, Consultant: Janssen, MSD, Spectrum; Financial Interests, Personal, Speaker’s Bureau: Librerium; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Librerium. J. Kuzdzal: Financial Interests, Institutional, Principal Investigator, PI in clinical studies: Bristol Myers Squib, Roche; Financial Interests, Personal, Other, Statutory Grants: Jagiellonian University Medical College; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Jagiellonian University Medical College; Financial Interests, Personal, Leadership Role: Regional Government Consultant in Thoracic Surgery; Financial Interests, Personal, Stocks/Shares: Medycyna Praktyczna Publishing House, Medycyna Praktyczna Education, Technet printing company. L. Wu: Financial Interests, Personal, Speaker’s Bureau: MSD, AstraZeneca, Roche China, Bristol Myers Squibb, Pfizer, Lilly, Innovate Biopharmaceuticals, Hengrui Medicine. J. Pujol: Financial Interests, Institutional, Funding: BMS. T. Ciuleanu: Financial Interests, Institutional, Other, Principal Investigator: Jounce Therapeutics. L.D.O.M. Koch: Financial Interests, Personal, Other, Support for attending meetings and/or travel: MSD, Bristol Myers Squibb. S.I. Blum: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. L. Vo: Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb; Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. C. Coronado Erdmann: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb, Incyte. S. Meadows-Shropshire: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. T. Cascone: Financial Interests, Personal, Other, Speaker fees/honoraria: Society for Immunotherapy of Cancer (SITC), MarkFoundation for Cancer Research, Bristol Myers Squibb, Roche, Medscape, IDEOlogy Health, Physicians' Education Resource® LLC (PER®), OncLive, PeerView; Financial Interests, Personal, Advisory Role: MedImmune/AstraZeneca, Bristol Myers Squibb, Merck, Genentech, Arrowhead Pharmaceuticals, Pfizer Inc., Regeneron; Financial Interests, Personal, Other, Travel and/or food/beverage expenses: Society for Immunotherapy of Cancer (SITC), International Association for the Study of Lung Cancer, Parker Institute for Cancer Immunotherapy, Physicians' Education Resource® LLC (PER®), Dava Oncology, IDEOlogy Health, OncLive, MedImmune/AstraZeneca, Bristol Myers Squibb; Financial Interests, Institutional, Research Grant: EMD Serono, MedImmune/AstraZeneca, Bristol Myers Squibb. All other authors have declared no conflicts of interest.