Real-world clinical outcomes in Chinese patients with EGFR-mutated NSCLC progressed from first-line EGFR-TKI: A prospective multicenter study.

Abstract

e20547 Background: EGFR-TKIs is standard of care for treatment-naïve EGFR mutated ( EGFRm) advanced NSCLC (aNSCLC). The clinical outcome after 1L EGFR-TKI in clinical practice is not well studied prospectively. Herein, we reported the real-world clinical outcomes in Chinese EGFRm aNSCLC progressed from 1L EGFR-TKI. Methods: This prospective, observational study enrolled 300 Chinese patients (pts) from 16 sites between March, 2020 and August, 2021. At data cut-off date of August 27, 2023. 291 eligible pts were included into the full analysis set (FAS) and 225 pts in FAS received second-line EGFR-TKI or chemotherapy were included into outcome analysis set (OAS). The clinical outcome (PFS and OS, measured from 2nd line treatment) were presented. Results: The median age of 291 pts in FAS was 62 years, 57.0% was females and 29.3% pts with brain metastasis. EGFR mutation included 19del (143 pts, 49.1%), L858R (126 pts, 43.3%) and others (22 pts, 7.6%). 273 (93.8%) and 18 (6.2%) pts progressed from 1L 1G/2G EGFR-TKIs and 3G EGFR-TKIs, respectively. In OAS, overall mPFS and mOS in T790M + patients (90 pts) who received 2L 3G EGFR-TKIs were 14.7 (10.40-18.0) and 32 (25.20-NE) months, respectively. The mPFS and mOS by type of sample and T790M test results were presented in table. 85 pts with T790M- who progressed from 1L 1/2G EGFR-TKIs, including 51, 9 and 25 pts received 3G EGFR-TKIs, prior EGFR-TKIs plus local therapy, and chemotherapy as 2L therapy, respectively. The corresponding mPFS were 7.60 (95% CI, 4.70-10.40), 10.20 (2.30-14.90), and 4.90 (2.50-6.90) months, respectively. The corresponding mOS were 21.20 (12.10-NE), 16.60 (6.00-28.60), and 15.00 (9.40-NE) months, respectively. For T790M- patients with 19del (21 pts) and L858R (26 pts) mutation who received 2L 3G EGFR-TKIs, the mPFS was 21.00 (2.60-NE), and 8.00 (5.00-10.40) months, respectively. mOS was NE (21.00-NE) and 16.60 (8.20-24.60) months, respectively. 12 pts progressed from 1L 3G EGFR-TKIs, 10 and 2 pts received chemotherapy-based regimen and prior EGFR-TKIs plus local therapy as 2L therapy, respectively. The corresponding overall mPFS were 8.40 (95% CI: 1.20-11.80) months. The overall mOS was 14.20 (2.80-NE) months. Conclusions: The real-world treatment pattern and corresponding prognosis of EGFR-mutated NSCLC progressed from first-line EGFR-TKI were diverse, and among them those who received 3G EGFR-TKI at progression showed a better clinical outcome. These results supplemented the clinical evidence for the use of 3G EGFR-TKIs in EGFRm aNSCLC pts who progressed from 1L 1/2G EGFR-TKIs in the real-world setting. Clinical trial information: NCT04207775 . [Table: see text]