Abstract 1123P
Background
Osimertinib is currently the first-line standard of care for EGFR mutated (EGFRm) advanced non-small cell lung cancer (NSCLC) based on its superior efficacy in FLAURA study. However, limited real-world data is available in China. FLOURISH is a multicenter, prospective, non-interventional study to evaluate the real-world efficacy and safety of first-line therapy of osimertinib for EGFRm NSCLC patients in China.
Methods
Eligible patients with EGFRm (19del or L858R) advanced NSCLC who has received osimertinib monotherapy as first-line therapy were enrolled from 24 sites in China. This interim analysis presents the preliminary efficacy and safety results in the first 96 enrolled patients among a total of 441 patients enrolled between July 27, 2020 and March 23, 2022. The outcome included objective response rate (ORR), disease control rate (DCR), and 1-year progression-free survival (PFS) rate. The data cut-off was March 23, 2022. Clinical trial number: NCT04391283.
Results
The median age was 64 years (range, 31-86), most patients were female (62.5%), ECOG PS 0 or1 (96.4%), adenocarcinoma (92.7%), stage IV (95.7%), ≥1 comorbidity (77.7%, including 5% with HBV), and 50.0% patients had central nervous system (CNS) metastases. ORR was 60.0%, DCR was 96.3%. After a median follow-up of 10.2 months, the 1-year PFS rate was 78.8% (95%CI, 66.9-86.8). In patients with CNS metastases, the ORR and DCR were 60.0% and 95.0%, respectively, and the 1-year PFS rate was 78.9% (95%CI, 62.1-88.8). Overall, adverse events were observed in 31.2% patients, including 2.1% grade 3 or higher treatment-related adverse events. Osimertinib was generally well tolerated and no new safety signals was reported.
Conclusions
FLOURISH is the largest prospective real-world study of first-line osimertinib in Chinese EGFRm NSCLC. Although in a population with high disease burden of CNS metastasis and comorbidities, the 1-year PFS rate in EGFRm NSCLC demonstrated clinical effectiveness similar to FLAURA clinical trial without new safety signal. The follow-up is still ongoing and the updated analysis in a larger population is expected in the future.
Clinical trial identification
NCT04391283.
Editorial acknowledgement
Legal entity responsible for the study
Guangdong Association of Clinical Trials.
Funding
AstraZeneca China.
Disclosure
All authors have declared no conflicts of interest.