Table 2.
Randomized Phase 3 Studies with Osimertinib in EGFR-Mutated NSCLC
| AURA 3 EGFR T790M NSCLC14 | FLAURA Untreated EGFR-Mutated NSCLC17,18 | ||||
|---|---|---|---|---|---|
| All patients | |||||
| Osimertinib | PLATINUM-pemetrexed | Osimertinib | Gefitinib/erlotinib | ||
| n | 279 | 140 | 223 | 210 | |
| ORR (%) | 71 | 31 | 80 | 76 | |
| PFS (month) | 8.5 | 4.2 | 18.9 | 10.2 | |
| HR PFS 95% CI 0.30 (0.23–0.41) | HR PFS 95% CI 0.46 (0.37–0.57) | ||||
| OS (month) | 26.8 | 22.5 | 38.6 | 31.8 | |
| HR OS 95% CI 0.87 (0.61–1.12) | HR OS 95% CI 0.80 (0.64–1.00) | ||||
| Patients with cerebral metastasis | |||||
| n | 75 | 41 | 61 | 67 | |
| CNS ORR (%) | 40 | 17 | 66 | 43 | |
| PFS (month) | 8.5 | 4.2 | NR** | 13.9** | |
| PFS HR 95% CI 0.32 (0.21–0.49) | PFS CNS HR 95% CI 0.48 (0.26–0.86) | ||||
| OS (month) | - | - | |||
| OS HR 95% CI 1.19 (0.79–1.83) | OS HR 95% CI 0.83 (0.53–1.30) | ||||
| Patients with EGFR Del19 | |||||
| n | 68 | 62 | 158 | 155 | |
| PFS HR 95% CI | 0.34 (0.24–0.46) | 0.43 (0.32–0.56) | |||
| OS HR 95% CI | - | 0.68 (0.51–0.90) | |||
| Patients with EGFR L858R | |||||
| n | 30 | 32 | 97 | 90 | |
| PFS HR 95% CI | 0.46 (0.30–0.71) | 0.51 (0.36–0.71) | |||
| OS HR 95% CI | - | 1.00 (0.71–1.40) | |||
Note: **CNS PFS.
Abbreviation: CNS, central nervous system.