1418P - Impact of TTFields therapy on global and functional health-related quality of life (HRQoL) in metastatic non-small cell lung cancer (mNSCLC) from the pivotal LUNAR study

Background

Tumor Treating Fields (TTFields) are electric fields that disrupt processes critical for cancer cell survival. The randomized, pivotal LUNAR study met its primary endpoint, demonstrating significantly improved OS with TTFields/standard of care (SOC; investigator’s choice immune checkpoint inhibitor or docetaxel) vs SOC in mNSCLC following platinum failure without added systemic toxicity. A prior study in glioblastoma showed that adding TTFields therapy to standard chemotherapy did not adversely affect HRQoL. Herein we report global and functional HRQoL from LUNAR.

Methods

Adults with mNSCLC progressing on/after platinum therapy were randomized 1:1 to TTFields/SOC or SOC. HRQoL was assessed at baseline (BL) and every 6 weeks (to 54 weeks) by the EORTC QLQ-C30 questionnaire. HRQoL outcomes from global health and functional scales are reported here. Scores were calculated as mean change from BL (change of ≥10 points considered clinically relevant). Time to deterioration (TTD) was defined as time from BL to a deterioration of ≥10 points without a subsequent ≥10-point improvement (and no death before the confirmatory assessment). TTD was estimated by Kaplan–Meier plots with medians by Greenwood's formula and comparisons by 2-sided log-rank tests.

Results

BL scores were comparable for patients receiving TTFields/SOC (n=134) vs SOC (n=136) in global health status and functioning. Overall, there were no notable differences in change from BL in these scales over time between groups. There were no significant differences between TTFields/SOC vs SOC for median TTD in global health status (4.4 vs 4.0 months, P=0.91), physical functioning (3.2 vs 4.2 months, P=0.58), role functioning (3.0 vs 2.8 months, P=0.59), emotional functioning (6.6 vs 5.7 months, P=0.96), cognitive functioning (3.7 vs 4.4 months, P=0.23), or social functioning (4.0 vs 3.9 months, P=0.66).

Conclusions

The HRQoL analysis conducted as part of LUNAR demonstrated that the TTFields device did not adversely affect the quality of life of patients receiving standard second-line therapies, supporting its incorporation into management guidelines for recurrent or progressive, platinum-refractory mNSCLC.

Clinical trial identification

NCT02973789.

Editorial acknowledgement

Editorial support was provided by Chelsea Higgins, PhD, CMPP, Huda Ismail Abdullah, PhD, Rose Goodchild, PhD, and Melissa Purves, PhD, CMPP, funded by Novocure. Ltd.

Legal entity responsible for the study

Novocure.

Funding

Novocure.

Disclosure

R. Kotecha: Financial Interests, Institutional, Research Grant: AstraZeneca, Blue Earth Diagnostics, Brain Lab , Cantex Pharmaceuticals Inc., Exelixis, GT Medical Technologies, Medtronic Inc., Novocure, ViewRay Inc.; Financial Interests, Personal, Speaker, Consultant, Advisor: Castle Biosciences, Elekta AB, Kazia Therapeutics, ViewRay Inc.; Financial Interests, Personal, Other, Honoraria, travel: Accuray Inc., Elekta AB, Novocure, Peerview Institute for Medical Education; Financial Interests, Personal, Other, Honoraria: Brain Lab, Elsevier Inc., ViewRay Inc.; Financial Interests, Personal, Advisory Board: ViewRay Inc. T.A. Leal: Financial Interests, Institutional, Research Grant: Novocure, Advaxis, Pfizer; Financial Interests, Personal, Speaker, Consultant, Advisor: Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Blueprint, Daiichi Sankyo, Eisai, Eli Lilly, EMD Serono, Genentech, Janssen, Jazz Pharmaceuticals, Merck, Mirati, Novocure, Regeneron, Roche, Takeda; Financial Interests, Personal, Other, Honoraria: Aptitude Health, Astro, Bioascend, Cardinal Health, Curio, Grace, I3 Health, Ideo, Larvol, Medscape, Peerview Institute for Medical Education, OncLive, Opinions in Lung Cancer, Society for Immunotherapy of Cancer, Targeted Oncology, UpToDate, Vindico; Financial Interests, Personal, Member of Board of Directors: National Cancer Institute (USA), Georgia Society of Clinical Oncology. R. Raumlau: Financial Interests, Personal, Advisory Board: Roche, Boehringer Ingelheim, Pfizer, MSD, BMS, Novartis, Takeda, Parexel; Financial Interests, Personal, Invited Speaker: Roche, Boehringer Ingelheim, Novartis, Pfizer, Amgen, BMS, MSD, Merck, AstraZeneca, Parexel; Financial Interests, Personal, Coordinating PI: Bioatla Inc, Janssen-Cilag, AstraZeneca, Maia Biothechnology, Cantargia AB, Shanghai Henlius Biotech, BioNtech SE, Arcus Biosciences Inc. L. Zhang: Financial Interests, Institutional, Research Grant, research grant & Trial Chair: AZ; Financial Interests, Institutional, Research Grant: BMS, Roche; Financial Interests, Institutional, Trial Chair: QiLu Pharm, Henrui Pharm, Novartis, Hansoh Pharma, China Shiyao Pharma, Kelun Pharm. J.P. Ward: Financial Interests, Institutional, Research Grant: American Cancer Society, American Lung Association, AstraZeneca, Central Society for Clinical and Translational Research, Gateway for Cancer Research, National Institutes of Health (US), Siteman Cancer Center; Financial Interests, Personal, Speaker, Consultant, Advisor: Novocure, Takeda; Financial Interests, Personal, Other, Honoraria: Washington University Continuing Medical Education, OncLive; Financial Interests, Personal, Other, Travel: Neon Therapuetics; Financial Interests, Personal, Advisory Board: Washington University. Z.G. Andric: Financial Interests, Personal, Invited Speaker: MSD, Roche, AstraZeneca, Novartis, Merck-D. T. Berghmans: Financial Interests, Personal, Speaker, Consultant, Advisor: InhaTarget; Financial Interests, Personal, Advisory Board: Bayer, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Merck, Roche; Financial Interests, Personal, Other, Travel: Takeda. G. Kloecker: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Bristol Myers Squibb, EMD Serono, Genentech, Merck, Novartis, Regeneron; Financial Interests, Personal, Royalties: McGraw Hill; Financial Interests, Personal, Speaker, Consultant, Advisor: Primum. R. Panikkar: Financial Interests, Institutional, Research Funding: National Cancer Institute (USA); Financial Interests, Institutional, Other, leadership position and travel support: National Community Oncology Dispensing Association. J.G. Aerts: Financial Interests, Personal, Advisory Board: BMS, MSD, Eli Lilly; Financial Interests, Institutional, Advisory Board: AstraZeneca, Pamgene; Financial Interests, Personal, Invited Speaker: AstraZeneca, Eli Lilly, Takeda; Financial Interests, Personal, Other, Inventor/medical advisor: Amphera; Financial Interests, Personal, Stocks/Shares, value is undetermined: Amphera; Financial Interests, Institutional, Royalties, and personal if granted: Amphera; Financial Interests, Institutional, Coordinating PI: Eli Lilly, BMS; Non-Financial Interests, Leadership Role: IASLC. M. Pless: Financial Interests, Personal, Speaker, Consultant, Advisor: AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eisei, Merck, MSD, Novartis, Pfizer, Roche, Takeda; Financial Interests, Personal, Other, Honoraria: Amgen, Bayer, Janssen, Nestle, Sanofi; Financial Interests, Personal, Other, support for meeting attendance or travel: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Roche, Takeda, Vifor. R. Greil: Financial Interests, Personal, Advisory Board: Celgene, Novartis, Roche, BMS, Takeda, AbbVie, AstraZeneca, Janssen, MSD, Merck, Gilead, Daiichi Sankyo, Sanofi; Financial Interests, Personal and Institutional, Funding: Celgene, Roche, Merck, Takeda, AstraZeneca Novartis, Amgen, BMS, MSD, Sandoz, AbbVie, Gilead, Daiichi Sankyo. W. Akerley: Financial Interests, Institutional, Research Grant: AstraZeneca, Bristol Myers Squibb. C.J. Langer: Financial Interests, Institutional, Research Funding: AstraZeneca, Eli Lilly, Fujifilm, Janssen Pharmaceuticals, Inovio, Merck, Oncocyte, Takeda, Trizell; Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Boehringer lngelheim, Genentech/Roche, Gilead, GSK, Merck, Mirati, Novocure, Pfizer, Regeneron, Sanofi-Aventis, Takeda; Financial Interests, Personal, Advisory Board: Amgen, OncocyteDX, Radiation Therapy Oncology Group (RTOG) Foundation, Veterans Administration; Financial Interests, Personal, Writing Engagement: Novartis. All other authors have declared no conflicts of interest.