Abstract 64P
Background
In EMPOWER-Lung 3 (NCT03409614) Part 1, patients with aNSCLC and PD-L1 <50% were randomized to 3 treatment arms: CHEMO, CEMI+CHEMO or CEMI+IPI+CHEMO. Clinical outcomes for CEMI+IPI+CHEMO vs CHEMO (including OS [HR: 0.615 (95% CI, 0.441–0.857)]) were previously reported; safety profile was generally consistent with the known safety for CEMI, CHEMO and IPI. PROs were evaluated and reported here.
Methods
PROs were assessed at day 1 (baseline), the start of each treatment cycle (every 3 weeks) for the first 6 doses, and then the start of every 3 cycles, using the EORTC QLQ-C30 and QLQ-LC13 questionnaires. Time to definitive clinically meaningful deterioration (TTD) analysis was conducted and between-arm (CEMI+IPI+CHEMO [n=109] vs CHEMO [n=106]) TTD comparisons were made per stratified log-rank test and proportional hazards model for global health status (GHS)/quality of life (QoL). A mixed-effect model for repeated measures compared overall differences in score changes from baseline between arms. No adjustments for multiplicity were conducted.
Results
Significant delay in TTD in GHS/QoL favouring CEMI+IPI+CHEMO vs CHEMO [HR: 0.45 (95% CI, 0.23–0.86); P=0.014] was observed; significant TTD delays favouring CEMI+IPI+CHEMO were also observed in functions: physical, role, emotional and social; and symptoms: fatigue, nausea/vomiting, pain, dyspnoea (QLQ-C30), insomnia, appetite loss, diarrhoea, sore mouth, peripheral neuropathy, alopecia, pain in arm or shoulder, pain in chest, and pain in other parts. Significant overall differences in score changes favouring CEMI+IPI+CHEMO vs CHEMO was observed in fatigue, nausea/vomiting, appetite loss and alopecia. When comparing between arms, no analyses yielded statistically significant PRO results favouring CHEMO for any scale.
Conclusions
In patients with PD-L1 <50% aNSCLC, CEMI+IPI+CHEMO vs CHEMO resulted in significant overall improvement and delayed TTD in multiple cancer-related and lung cancer-specific PROs. Positive PROs further support the favourable benefit–risk profile of CEMI+IPI+CHEMO in 1L aNSCLC with PD-L1 <50%.
Clinical trial identification
NCT03409614.
Editorial acknowledgement
The study was funded by Regeneron Pharmaceuticals, Inc., and Sanofi. Editorial support was provided by Rachel McGrandle, MSc, of Alpha (a division of Prime, Knutsford, UK) funded by Regeneron Pharmaceuticals, Inc. 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.
Disclosure
A. Baramidze: Financial Interests, Personal, Other, Travel support: Regeneron Pharmaceuticals, Inc. C. Gessner: Financial Interests, Personal, Advisory Board: AstraZeneca, Berlin-Chemie, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, GSK, Merck Sharp & Dohme, Novartis, Pfizer, Roche and Sanofi. K. Dunnigan, X. He, P. Rietschel, 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.