562P First-line (1L) osimertinib (osi) ± platinum-pemetrexed in patients (pts) with EGFRm advanced NSCLC: FLAURA2 China cohort

Osi is a third-generation, CNS active EGFR-TKI. The primary analysis of the global, phase III, open-label, randomised FLAURA2 (NCT04035486) study in pts with EGFRm advanced NSCLC demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with 1L osi + chemotherapy (osi + CT) vs osi monotherapy (osi-mono). We report data of pts in China from FLAURA2. Eligible pts (aged ≥18 yrs with locally advanced/metastatic EGFRm [Ex19del/L858R] NSCLC, WHO PS 0/1 and no prior systemic treatment [tx] for advanced NSCLC; stable CNS metastases allowed) were randomised 1:1 to osi + CT (osi 80 mg QD + pemetrexed [pem] 500 mg/m2 + either cisplatin 75 mg/m2 or carboplatin AUC5 Q3W for 4 cycles, followed by osi 80 mg QD + pem 500 mg/m2 Q3W) or osi-mono (80 mg QD) until progression/discontinuation criterion; stratified by race (Chinese Asian/non-Chinese Asian/non-Asian), EGFR mutation test method (local/central) and WHO PS (0/1). Primary endpoint: PFS by investigator assessment. Secondary endpoints included OS, ORR, DoR and safety. Data cut-off: 03 April 2023. Overall, 131 pts in China were randomised to osi + CT (n=67) or osi-mono (n=64). Baseline characteristics (osi + CT/osi-mono) were: median age (range), 61 (42–74)/60 (32–78) yrs; 63/59% female; 48/59% Ex19del; 51/39% L858R (1 unknown EGFR mutation type per arm); 51/42% CNS metastases. Osi + CT improved PFS vs osi-mono (49% maturity by investigator; Table). OS was immature (21% maturity); HR 0.97 (95% CI 0.45, 2.06). All grade ≥3 AEs (osi + CT/osi-mono): 75% (mainly haematological)/26%; AEs leading to osi discontinuation: 3/5%. In the China cohort, osi + CT demonstrated a clinically meaningful improvement in PFS over osi-mono with a manageable safety/tolerability profile consistent with the global study population, supporting osi + platinum-pem as a new 1L tx option for pts in China with advanced EGFRm NSCLC.Table: 562PEfficacy outputOsi + CT (n=67)Osi-mono (n=64)Median PFS by investigator, months (95% CI)27.4 (22.3, NC)22.3 (16.7, 25.0)HR (95% CI)0.56 (0.34, 0.92)Median follow-up for PFS, months (range)*22.3 (0–30.6)23.7 (3.0–33.1)Median PFS by BICR, months (95% CI)33.2 (25.1, NC)22.0 (16.6, NC)HR (95% CI)0.58 (0.34, 1.01)Median follow-up for PFS, months (range)*24.2 (0–30.5)22.3 (3.0–33.2)ORR by investigator, n (%)58 (87)49 (77)Median DoR by investigator, months (95% CI)26.2 (20.7, NC)20.8 (15.3, 23.5)∗In censored pts.BICR, blinded independent central review; CI, confidence interval; DoR, duration of response; HR, hazard ratio; NC, not calculable; NR, not reached; ORR, objective response rate Open table in a new tab