Table 3.
Major ALK Inhibitor Clinical Trials for First-Line Therapy in ALK-Rearranged Non–Small Cell Lung Cancer
| Trial | PROFILE 101429 | ASCEND-452 | J-ALEX65 | ALEX67 | ALTA 1L79 |
|---|---|---|---|---|---|
| ALK inhibitor | Crizotinib (n=172) | Ceritinib (n=189) | Alectinib (n=103) | Alectinib (n=152) | Brigatinib (n=137) |
| Comparator | Platinum-based chemotherapy (n=171) | Platinum-based chemotherapy (n=187) | Crizotinib (n=104) | Crizotinib (n=151) | Crizotinb (n=138) |
| Primary end point | Median PFS (months) | Median PFS (months) | Median PFS (months) | Median PFS (months) | Median PFS (months) |
| Response rate (%) | 74 vs 45 | 72.5 vs 26.7 | Not reported | 82.9 vs 75.5 | 71 vs 60 |
| Median PFS (months) | 10.9 vs 7 (HR 0.45, 95% CI 0.35–0.60; p<0.001) | 16.6 vs 8.1 (HR 0.55, 95% CI 0.42–0.73; p<0.00001) | 34.1 vs 10.2 (HR 0.37, 95% CI 0.26–0.52; p<0.0001) | 34.8 vs 10.9 (HR 0.43, 95% CI 0.32–0.58; p<0.01) | Not reached vs 9.8 (HR 0.49, 95% CI 0.33–0.74; p=0.0007) |
| Median OS (months) | Not reached vs 47.5 (HR 0.76, 95% CI 0.548–1.05; p=0.0978 | Not reached vs 26.2 (HR 0.73, 95% CI 0.5–1.08; p=0.056 | — | Not reached vs not reached (HR 0.76, 95% CI 0.50–1.15) | — |
Abbreviations: OS, overall survival; PFS, progression-free survival.