Table 3.
Efficacy of third-generation EGFR TKIs in EGFR T790M-positive NSCLC patients
Drug | Trial | Patients (N) | Dose | ORR T790M | PFS (mo.) |
---|---|---|---|---|---|
Osimertinib | AURA phase I [92] | Total: 253 T790M(+): 138 | 20-240 mg QD | T790M(+): 61% T790M(−): 21% | T790M(+): 9.6 T790M(−): 2.8 |
AURA phase I T790M(+) | 63 | 80 mg QD | 71% | 9.7 | |
AURA phase II | 210 | 80 mg QD | 70% | 9.9 | |
AURA phase II extension [132] | 411 | 80 mg QD | 62% | 12.3 | |
AURA phase III [84] | 416 -Osimertinib arm: 279 -Chemotherapy arm: 140 |
71% 31% Odds ratio:5.39 (95% CI: 3.47–8.48) |
10.1 4.4 HR: 0.30 (95% CI: 0.23–0.41) |
||
Rociletinib | TIGER-X phase I/II [98] | Total: 69 T790M(+): 51 |
500, 625 or 750 mg bid | 45% | T790M(+): 9.6 T790M(−): 2.8 |
Olmutinib | HM-EMSI-101 phase I/II T790M(+) [133] | 76 | 800 mg QD | 62% | 6.9 |
ASP8273 | NCT02113813 phase I/II [134] | Total: 63 T790M(+): 58 |
300 mg QD | 29% | 6.8 |
Nazartinib | NCT02108964 phase I/II [105] | 152 | 75-350 mg QD | 46.9% | 9.7 |
Avitinib (AC0010) | NCT02330367 phase I/II [106] | 136 | 50-350 mg QD | 44% |