563P - Real-world effectiveness and safety of first-line osimertinib for EGFR-mutated advanced NSCLC in China (FLOURISH study)

Background

Osimertinib, the standard first-line therapy for EGFR-mutated (EGFRm) advanced non-small cell lung cancer (NSCLC), preliminarily demonstrated similar clinical effectiveness to the landmark FLAURA study in the prospective, non-interventional, real-world FLOURISH study at the first interim analysis. This report presents an updated effectiveness and safety results.

Methods

A total of 500 patients were recruited into the FLOURISH study from 22 sites in China between July 27, 2020, and April 27, 2022. This analysis included 460 patients who met the eligibility criteria and received at least one dose of osimertinib after enrolment and without protocol violation into the full analysis set (FAS) for effectiveness analysis, and 495 patients who received at least one dose of osimertinib after enrolment into the safety set (SS). The data cut-off date was June 30, 2023.

Results

Of the 460 patients in FAS, the median age was 64.1 years (range: 27-88), 62.4% were female, 64.8% had comorbidities, 35.0% with CNS metastases, and 98.7% in stage IIIB-IV. The objective response rate (ORR) was 61.8% (238/385), and disease control rate (DCR) was 96.1% (370/385) in evaluable patients. With a median follow-up of 18.0 months, the 1-year progression-free survival (PFS) and 1-year overall survival (OS) rate was 79.6% (95%CI: 75.0%-83.3%) and 90.0% (95%CI: 86.8%-92.5%), respectively. In patients with CNS metastases, ORR was 63.8% (90/141), DCR was 95.0% (134/141), 1-year PFS rate was 78.9%, and 1-year OS rate was 90.1%. Moreover, patients with exon 19 deletion (n=235) had higher 1-year PFS (84.2% vs. 75.0%) and 1-year OS (93.4% vs. 86.8%) rates than patients with exon 21 L858R (n=212). Among the 495 patients in SS, 195 patients (39.4%) experienced adverse events (AEs), with 18(3.6%) of grade ≥3. AEs leading to dose interruption or discontinuation were reported in 3 (0.6%) and 12(2.4%) patients, respectively.

Conclusions

The FLOURISH study showed consistence with FLAURA in terms of effectiveness of first-line osimertinib for Chinese patients with advanced EGFRm-NSCLC in real world setting. No new safety signals were observed. The follow-up is still ongoing and the final analysis is expected in 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.