80P A phase Ib/II study of second-line cadonilimab, anlotinib and docetaxel in patients with checkpoint inhibitor (CPI)-experienced advanced non-small cell lung cancer

Background: In EMPOWER-Lung 3 (NCT03409614), cemiplimab (CEMI) plus chemotherapy (CHEMO) improved overall survival versus placebo (PBO) plus CHEMO, with a consistent safety profile.Here we report post hoc exploratory analyses of PROs by age (<65 and 65 years).Methods: PROs were assessed using the EORTC QLQ-C30 and QLQ-LC13 questionnaires.Time to definitive clinically meaningful deterioration (TTD) based on a 10-point threshold was analysed using a stratified Cox proportional hazards model.Mixed-model for repeated-measures analyses compared overall change from baseline scores between treatment arms, while controlling for baseline characteristics.Results: In patients aged <65 years (n=278), a significant delay in TTD favouring CEMI + CHEMO was seen in physical functioning (HR=0.62 [95% CI: 0.38, 1.01]; P=0.050), role functioning (0.57 [0.35, 0.93]; 0.021), pain (0.45 [0.25, 0.81]; 0.007), C30 dyspnoea (0.41 [0.21, 0.81]; 0.008), constipation (0.44 [0.19, 0.99]; 0.043), coughing (0.38 [0.17, 0.83]; 0.011), dysphagia (0.30 [0.12, 0.73]; 0.005) and alopecia (0.34 [0.20, 0.58]; <0.0001).A significant difference in overall change in PRO scores from baseline favouring CEMI + CHEMO was seen in pain (LS mean difference = -4.51[95% CI: -8.53, -0.49]; P=0.028) and constipation (-4.0 [-7.75, -0.24]; 0.037).In patients aged 65 years (n=188), a significant delay in TTD favouring CEMI + CHEMO was found in nausea/vomiting (0.26 [0.11, 0.65]; 0.002), pain (0.30 [0.16, 0.56]; <0.0001), alopecia (0.42 [0.23, 0.76]; 0.004), pain in chest (0.34 [0.13, 0.86]; 0.018) and pain in other parts (0.33 [0.13, 0.83]; 0.014).A significant difference in overall change in PRO scores from baseline favouring CEMI + CHEMO was seen in emotional functioning (LS mean difference = 4.49 [0.34, 8.64]; 0.034), pain (-7.17 [-12.69,-1.66]; 0.011) and alopecia (-9.0 [-16.52,-1.47]; 0.020).No analyses yielded PROs favouring PBO + CHEMO in either age subgroup. Conclusions:In aNSCLC, for both age subgroups, CEMI + CHEMO had significant benefits over PBO + CHEMO in overall change from baseline and delayed TTD across multiple PROs, further supporting the efficacy of CEMI + CHEMO.Clinical trial identification: NCT03409614.