Abstract 49P
Background
In subgroup analyses of EMPOWER-Lung 1, a randomised 1:1 open-label phase III study, improvement in overall survival (OS) with CEMI (n = 48) vs CHEMO (n = 47) (median OS: not reached vs 7.4 months; HR: 0.38; 95% confidence interval [CI]: 0.19, 0.75) was observed in patients with aNSCLC with PD-L1 ≥ 50% and baseline liver metastases. In this post hoc analysis, we evaluated PROs.
Methods
PROs were assessed at baseline and Day 1 of each treatment cycle for the first 6 cycles, then on Day 1 of every third cycle using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (QLQ-C30) and Lung Cancer 13 (QLQ-LC13) questionnaires. Higher scores indicate better functioning and global health status (GHS)/quality of life (QoL) or worse symptom severity. Mixed-effects repeated-measures analyses were used to compare overall change from baseline scores between the treatment arms, controlling for baseline scores and other covariates.
Results
Statistically significant difference in overall change from baseline in physical functioning favoured CEMI vs CHEMO (6.24; 95% CI: 0.34, 12.14; P = 0.0384). CEMI also resulted in a statistically significant favourable difference vs CHEMO in overall change from baseline in the symptoms of nausea/vomiting (−3.80; 95% CI: −7.29, −0.31; P = 0.0334), alopecia (−15.75; 95% CI: −24.61, −6.88; P = 0.0007) and pain in arm or shoulder (−9.05; 95% CI:−16.67, −1.43; P = 0.0208). Compared with CHEMO, CEMI had numerically improved scores in GHS/QoL, all functioning scales, and 15 of 18 symptom scales. No analyses yielded statistically significant PRO results favouring CHEMO vs CEMI on any QLQ-C30 or QLQ-LC13 scales.
Conclusions
In patients with aNSCLC with PD-L1 ≥50% and baseline liver metastases, CEMI resulted in significant favourable overall change from baseline in physical functioning, nausea/vomiting, alopecia and pain in arm or shoulder symptoms vs CHEMO. PRO results further support the favourable benefit-risk profile of first-line CEMI vs CHEMO in patients with aNSCLC with PD-L1 ≥50% and baseline liver metastases.
Clinical trial identification
NCT03088540.
Editorial acknowledgement
Medical writing support was provided by John G Facciponte, PhD, of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc. and Sanofi. Responsibility for all opinions, conclusions, and data interpretation lies with the authors.
Legal entity responsible for the study
Regeneron Pharmaceuticals, Inc.
Funding
Regeneron Pharmaceuticals, Inc. and Sanofi.
Disclosure
A. Baramidze: Financial Interests, Personal, Other, Travel support: Regeneron Pharmaceuticals, Inc. C. Gessner: Financial Interests, Personal, Advisory Board: GlaxoSmithKline, Pfizer, AstraZeneca, Roche, Novartis, Bristol-Myers Squibb, Merck Sharp & Dohme, Berlin-Chemie, Chiesi, Boehringer Ingelheim, Sanofi. A. Sezer: Financial Interests, Institutional, Research Grant: Roche, Merck Sharp & Dohme, Merck Serono, AstraZeneca, Eli Lilly, Novartis, Johnson & Johnson, Regeneron Pharmaceuticals, Inc., Sanofi. M. Gumus: Financial Interests, Personal, Advisory Role, Honoraria: Roche, Merck Sharp & Dohme, Gen İlaç, Novartis. X. He: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. G. Gullo: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. P. Rietschel: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. R. Quek: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. All other authors have declared no conflicts of interest.