Table 2.
Secondary efficacy endpoints
| Osimertinib | Gefitinib | |
|---|---|---|
| (n = 65) | (n = 55) | |
| OS, % (95% CI) | ||
| Survival at 12 months | 96.8 (87.7, 99.2) | 94.2 (83.0, 98.1) |
| Survival at 18 months | 90.1 (79.4, 95.5) | 83.7 (69.9, 91.5) |
| Objective responsea | ||
| Complete response, n (%) | 2 (3.1) | 0 |
| Partial response, n (%) | 47 (72.3) | 42 (76.4) |
| Adjusted response rateb, % | 76.8 | 77.1 |
| Odds ratio (95% CI) | 0.98 (0.41, 2.32) | |
| Median DoR from onsetc,d, months (95% CI) | 18.4 (NC, NC) | 9.5 (6.2, 13.9) |
| Disease controla | ||
| Patients under control, n (%) | 63 (96.9) | 53 (96.4) |
| Adjusted control rateb, % | 96.9 | 96.4 |
| Odds ratio (95% CI) | 1.19 (0.14, 10.23) | |
| Best percent change from baseline in target lesion size, unadjusted mean (SD) | −50.0 (25.3) | −45.6 (24.2) |
CI, confidence interval; EGFR, epidermal growth factor receptor; NC, not calculable; OS, overall survival; SD, standard deviation; DoR, duration of response.
aBased on investigator assessment.
bAdjusted using logistic regression analysis stratified by EGFR mutation type (exon 19 deletion vs L858R).
cDoR was the time from the first documentation of response until the date of progression or death in the absence of progression.
dCalculated using the Kaplan–Meier method.