Patient-reported Outcomes for the Phase 3 FURLONG Study of Furmonertinib Versus Gefitinib As First-Line Therapy for Chinese Patients with Locally Advanced or Metastatic EGFR Mutation-Positive Non-Small Cell Lung Cancer

Background Furmonertinib showed superior ef fi cacy compared with ge fi tinib as fi rst -line therapy in patients with epidermal growth factor receptor ( EGFR ) mutation -positive non -small cell lung cancer (NSCLC) in the FURLONG study. Here we present prespeci fi ed secondary endpoints of patient -reported outcomes (PRO). Methods In this multicentre, double-blind, double -dummy, randomised phase 3 study, patients were 1:1 randomly assigned to receive furmonertinib 80 mg once daily or ge fi tinib 250 mg once daily. PROs assessed by the European Organization for Research and Treatment of Cancer Quality -of -Life Questionnaire Core 30 and Quality -ofLife Questionnaire Lung Cancer 13 were analysed using a mixed model for repeated measures and time -to -event analyses. A difference in score of 10 points or more was deemed clinically relevant. Findings Three hundred and fi fty-seven patients (furmonertinib group, n = 178; ge fi tinib group, n = 179) received at least one dose of the study drug, all of whom completed at least one PRO assessment. Statistically signi fi cant difference of overall score changes from baseline favoured furmonertinib in physical functioning (between -group difference 2.14 [95% CI 0.25 - 4.04], p = 0.027), nausea/vomiting ( - 1.56 [95% CI - 2.62 to - 0.49], p = 0.004), appetite loss ( - 2.24 [95% CI - 4.26 to - 0.23], p = 0.029), diarrhoea ( - 3.36 [95% CI - 5.19 to - 1.54], p < 0.001), alopecia ( - 2.62 [95% CI - 4.54 to - 0.71], p = 0.007), and pain in other parts ( - 4.55 [95% CI - 7.37 to - 1.74], p = 0.002), but not reached clinical relevance. Time to deterioration in physical functioning (hazard ratio 0.63 [95% CI 0.42 - 0.94], p = 0.021), cognitive functioning (0.73 [95% CI 0.54 - 0.98 ], p = 0.034), nausea/vomiting (0.64 [95% CI 0.41 - 0.99], p = 0.042), appetite loss (0.63 [95% CI 0.43 - 0.92], p = 0.016), diarrhoea (0.63 [95% CI 0.46 - 0.85], p = 0.002), dyspnoea (0.72 [95% CI 0.53 - 0.98], p = 0.034), cough (0.67 [95% CI 0.44 - 1.00], p = 0.049), dysphagia (0.54 [95% CI 0.35 - 0.83], p = 0.004), and alopecia (0.62 [95% CI 0.42 - 0.90], p = 0.012) was longer with furmonertinib versus ge fi tinib. Interpretation In patients with locally advanced or metastatic EGFR mutation -positive NSCLC, furmonertinib showed improved scores and delayed deterioration in several functioning and symptoms compared to ge fi tinib.