Efficacy
After a median follow-up for DFS of 44.2 months in the osimertinib group and 19.6 months in the placebo group, the percentage of alive and disease-free stage II-IIIA patients at 48 months, was 70% (95% CI, 62 to 76) in the osimertinib group versus 29% (95% CI, 23 to 35) in the placebo group (HR 0.23; 95% CI, 0.18 to 0.30). The median DFS was 65.8 months (95% CI, 54.4 to not calculable) in the osimertinib group and 21.9 months (95% CI, 16.6 to 27.5) in the placebo group. In the overal population (stage IB-IIIA), median DFS was 65.8 months (95% CI, 61.7 to not calculable) versus 28.1 months (95% CI, 22.1 to 35.0) in osimertinib and placebo groups, respectively.r
In patients with stage II-IIIA disease, CNS DFS events occurred in 9% and 17% of patients in the osimertinib and placebo groups, respectively. In the overall population, disease recurrence was observed in 27% of patients in the osimertinib group and 60% of patients in the placebo group. In this population, osimertinib also resulted in an increased central nervous system (CNS) DFS events with 7% of patients in the osimertinib group and 15% of patients in the placebo group having recurrence of CNS disease or death at 48 months.r
The reference committee noted that there was an improvement in DFS but this needs to be balanced with the unknown survival benefit and potential toxicity.
HRQoL outcomes were maintained and there were no clinically meaningful differences between patients with stage IB-IIIA NSCLC treated with adjuvant osimertinib versus placebo.r
Kaplan-Meier estimates for DFS in (A) stage II-IIIA and (B) overall populations according to investigator assessmentr
© J Clin Oncol 2023
Kaplan-Meier estimates for CNS DFS in stage II-IIIA population according to investigator assessmentr
© J Clin Oncol 2023