Table 1.
Alectinib efficacy in selected and discussed clinical trials.
| Study | Phase | Treatment | Patients (n) |
Alectinib dose | ORR (%) |
PFS (months) |
|---|---|---|---|---|---|---|
| AF-001JP 40 | I/II | Single arm; recurrent; crizotinib naïve |
46 (phase II) | 300 mg b.i.d. | 93.5 | NR |
| NP28761 41,42 | II | Single arm; recurrent; crizotinib pretreated |
87 | 600 mg b.i.d. | 52.2 | 8 |
| NP28673 43,44 | II | Single arm; recurrent; crizotinib pretreated |
138 (evaluable 122) | 600 mg b.i.d. | 50 | 8.9 |
| ALUR 45 | III |
Versus chemotherapy; recurrent; crizotinib pretreated |
107 (72 alectinib arm) | 600 mg b.i.d. | 36.1 (versus chemotherapy, 11.4) |
7.1 (versus chemotherapy, 1.6) |
| J-ALEX 46 | III |
Versus crizotinib; first line |
207 (103 alectinib arm) | 300 mg b.i.d. | 85.4 (versus crizotinib, 70.2) |
NR (versus crizotinib, 10.2) |
| ALEX 47 | III |
Versus crizotinib; first line |
303(152 alectinib arm) | 600 mg b.i.d. | 82.9 (versus crizotinib, 75.5) |
NR (versus crizotinib, 11.1) |
NR, not reported; ORR, overall response rate; PFS, progression-free survival; b.i.d., twice daily.