Table 1. Clinical trials evaluating osimertinib.
Study ref | Treatment | No. of patients | ORR | PFS (months) |
---|---|---|---|---|
AURA 1 (phase 1) (12) | Osimertinib | 127 T790M+ | 61% (52–70%) | 9.6 (8.3–NR) |
AURA2 (phase 2) (13) | Osimertinib | 210 T790M+ | 70% (64–77%) | 9.9 (8.5–12.3) |
AURA 3 (phase 3) (14) | Osimertinib vs. platinum-pemetrexed | 419 T790M+ | 71 vs. 31, OR 5.39 (95% CI, 3.47–8.48), P<0.001 | 10.1 vs. 4.4, HR 0.30 (95% CI, 0.23–0.41), P<0.001 |
FLAURA (phase 3) (15) | Osimertinib vs. gefitinib or erlotinib | 556 naive | 80 vs. 76, OR 1.27 (95% CI, 0.85–1.90), P=0.24 | 18.9 vs. 10.2, HR 0.46 (95% CI, 0.37–0.57), P<0.001 |
ORR, objective response rate; OR, odds ratio; CI, confidence interval; PFS, progression free survival; HR, hazard ratio; NR, not reached.