Abstract 665P
Background
Osimertinib has been established as preferred standard of care in the first-line setting for EGFRm advanced non-small cell lung cancer (NSCLC). While the effectiveness of osimertinib as first line treatment for EGFRm advanced NSCLC in real world setting is limited.
Methods
FLOURISH is a real-world, multi-center, non-interventional, prospective study of 1L osimertinib in Chinese patients(pts) with EGFRm advanced NSCLC. Treatment naïve pts with locally advanced or metastatic EGFRm NSCLC were prospectively enrolled and received osimertinib monotherapy. The primary endpoint was time to discontinuation or death (TTD), secondary endpoints included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety.
Results
Between July 27, 2020 and April 27, 2022, 507 patients were screened in 22 sites in mainland China, and 481 patients were eligible and received at least one dose of osimertinib as 1L therapy. Of the 481 patients, median(m) age was 64.1 years (range: 27-88), 34.3% pts with CNS metastases, 82.3% pts had an ECOG PS of ≤2, and 93.6% pts with stage IV. Ex19del comprised 50.9 % and L858R 46.0%. At the time of data cutoff (April 27, 2024), an event of TTD had occurred in 266 patients (55.3%). mTTD was 24.6 months, mPFS was 19.2 months, and mOS was 41.0 months. 345 (71.7%) pts experienced AEs, with 56 (11.6%) of grade ≥3 and 22 (4.6%) leading to discontinuation of osimertinib. In patients with L858R (n=221) and CNS metastases (n=165), mPFS was 15.7 and 16.7 months, respectively (Table). Table: 665P
| Baseline EGFR mutation status | Baseline CNS metastases | |||
| ex19del (n=245) | L858R (n=221) | Absent (n=207) | Present (n=165) | |
| mTTD, mo | 28.6 | 20.5 | 25.3 | 22.2 |
| mPFS, mo | 20.6 | 15.7 | 19.7 | 16.7 |
| mOS, mo | 41.0 | 37.2 | 41.0 | 40.1 |
Conclusions
The prospective, multi-center, non-interventional FLOURISH study demonstrated comparable effectiveness of 1L osimertinib with previous data with an acceptable safety profile in real-world settings.
Clinical trial identification
NCT04391283.
Editorial acknowledgement
Legal entity responsible for the study
Guangdong Association of Clinical Trials, GACT.
Funding
AstraZeneca China.
Disclosure
All authors have declared no conflicts of interest.