Abstract 85P
Background
Osimertinib is a third-generation, EGFR-TKI with demonstrated efficacy in NSCLC, including CNS metastases. In Chinese pts with NSCLC, prevalence of EGFRm disease is high. In the global phase III ADAURA study (NCT02511106), adjuvant osimertinib demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) vs placebo (PBO) in pts with resectable stage II-IIIA (hazard ratio [HR] 0.17 [99.06% CI: 0.11, 0.26]; p<0.0001) and stage IB-IIIA (HR 0.20 [99.12% CI: 0.14, 0.30]; p<0.0001) EGFRm NSCLC. We present efficacy and safety data of a subgroup analysis of Chinese pts from ADAURA.
Methods
ADAURA enrolled adult pts with completely resected stage IB/II/IIIA NSCLC, EGFRm (Ex19del/L858R), and WHO PS 0–1. Adjuvant chemotherapy was allowed, per physician and pt choice before study entry. Pts were randomized 1:1 to osimertinib 80 mg once daily or PBO for up to 3 yrs (treatment completion) or until disease recurrence/discontinuation. Primary endpoint: investigator assessed DFS in pts with stage II–IIIA disease. Secondary endpoints included DFS in the overall population (stage IB–IIIA), overall survival and safety. Statistical analyses for this subgroup of Chinese pts were exploratory; p-values are nominal. Data cut-off (DCO): 17/01/20.
Results
Of 682 pts enrolled globally, 159 pts in mainland China were included in this subgroup analysis: osimertinib n=77, PBO n=82. Baseline characteristics were generally balanced across arms (osimertinib/PBO): median age 61/60 yrs, female 60/60%, stage IB 45/40%, stage II–IIIA 55/60%, Ex19del 47/38%, adjuvant chemotherapy 62/71%. At DCO, stage II–IIIA DFS HR was 0.16 (95% CI: 0.08, 0.31, p<0.0001; maturity 40%); stage IB–IIIA DFS HR was 0.18 (95% CI: 0.10, 0.33, p<0.0001; maturity 27%). A DFS benefit with osimertinib vs PBO was observed in all pre-specified subgroups of the China cohort with sufficient events for analysis. The safety profile of osimertinib was consistent with the global cohort and with the established safety of osimertinib.
Conclusions
Efficacy and safety data for Chinese pts in ADAURA were consistent with those reported for the global population.
Clinical trial identification
NCT02511106.
Editorial acknowledgement
Rachel Gater, PhD, of Ashfield MedComms, provided medical writing support that was funded by AstraZeneca.
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca.
Disclosure
W. Jie: Financial Interests, Personal, Other, Honoraria: Beigene; Financial Interests, Personal, Other, Honoraria: AstraZeneca; Financial Interests, Personal, Other, Honoraria: Boehringer Ingelheim; Financial Interests, Personal, Other, Honoraria: MSD. Y. Wu: Financial Interests, Personal, Other, Honoraria: AstraZeneca; Financial Interests, Personal, Other, Honoraria: Bristol Myers Squibb; Financial Interests, Personal, Other, Honoraria: Pfizer Inc.; Financial Interests, Personal, Other, Honoraria: Roche AG; Financial Interests, Personal, Other, Honoraria: Boehringer Ingelheim; Financial Interests, Personal, Other, Honoraria: Eli Lilly & Co; Financial Interests, Personal, Other, Honoraria: MSD; Financial Interests, Personal, Other, Honoraria: Sanofi; Financial Interests, Personal, Research Grant: AstraZeneca; Financial Interests, Personal, Research Grant: Bristol Myers Squibb; Financial Interests, Personal, Research Grant: Pfizer Inc.; Financial Interests, Personal, Research Grant: Roche AG. S. Lu: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Hutchison MediPharma; Financial Interests, Personal, Advisory Board: Simcere; Financial Interests, Personal, Advisory Board: ZaiLab; Financial Interests, Personal, Advisory Board: GenomiCare; Financial Interests, Personal, Advisory Board: Yuhan Corporation; Financial Interests, Personal, Advisory Board: PrIME Oncology; Financial Interests, Personal, Advisory Board: Menarini; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Role, Consulting fees: AstraZeneca; Financial Interests, Personal, Advisory Role, Consulting fees: Roche; Financial Interests, Personal, Advisory Role, Consulting fees: Hansoh; Financial Interests, Personal, Advisory Role, Consulting fees: Hengrui Therapeutics; Financial Interests, Personal, Other, Corporate-sponsored research: AstraZeneca; Financial Interests, Personal, Other, Corporate-sponsored research: Hutchinson; Financial Interests, Personal, Other, Corporate-sponsored research: Bristol Myers Squibb; Financial Interests, Personal, Other, Corporate-sponsored research: Heng Rui; Financial Interests, Personal, Other, Corporate-sponsored research: Beigene; Financial Interests, Personal, Other, Corporate-sponsored research: Roche. Y. Liu: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. X. Huang: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. A. Atasoy: Financial Interests, Personal, Member of the Board of Directors: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. All other authors have declared no conflicts of interest.