Table 2.
Efficacy and safety of osimertinib in clinical trials
| Trial | Phase | Number of patients | ORR (%) |
PFS (months) |
OS (months) |
AEs of osimertinib treatment |
|---|---|---|---|---|---|---|
|
AURA |
1/2 | 253 | 61 | 9.6 | / | Diarrhea (47%), rash (40%), nausea (22%), decreased appetite (21%) |
| AURA extension | 2 | 201 | 62 | 12.3 | / | Diarrhea (43%), rash (40%), dry skin (31%), paronychia (31%) |
|
AURA2 |
2 | 210 | 70 | 9.9 | / | Rash (41%), diarrhea (33%), dry skin (30%), paronychia (26%) |
|
AURA extension and AURA2 |
2 | 411 | 66 | 9.9 | 26.8 | Rash (42%), diarrhea (39%), dry skin (32%), paronychia (32%) |
|
AURA3 |
3 | 279 | 71 | 10.1 | 26.8 | Diarrhea (41%), rash (34%), dry skin (23%), paronychia (22%) |
|
FLAURA |
3 | 279 | 80 | 18.9 | 38.6 | Rash (58%), diarrhea (58%), dry skin (36%), paronychia (35%) |
| ADAURA (NCT02511106) | 3 | 682 | 57.1 |
NR* (38.8-NC) |
Awaited | Diarrhea (46%), paronychia (25%), dry skin (23%), pruritus (19%) |
ORR objective response rate, PFS progression-free survival, OS overall survival, AEs adverse events, NR not reached, NC could not be calculated
*represents disease-free survival (DFS)