TABLE 3.
Select ALK TKIs Currently in Clinical Use and/or Under Investigation for Patients With ALK- Rearranged NSCLC
| ALK TKIs | Status in Lung Cancer | Select Trial Details |
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|---|---|---|---|---|---|---|
| Trial/Name | Phase | No. of Patients* | ORR (%) | Median PFS (Months) | ||
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| First Generation | ||||||
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| Crizotinib | FDA approved | PROFILE 1014 | III | 343 | 74 | 10.9 |
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| PROFILE 1007 | III | 347 | 65 | 7.7 | ||
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| Second Generation | ||||||
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| Ceritinib | FDA approved | ASCEND-1 | I | 163 | 56 | 6.9 |
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| ASCEND-2 | II | 140 | 38.6 | 5.7 | ||
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| ASCEND-4** | III | 376 | 72.5 | 16.6 | ||
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| Alectinib | FDA approved | NP28673 | II | 138 | 50 | 8.9 |
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| NP28761 | II | 87 | 48 | 8.1 | ||
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| J-ALEX** | III | 207 | 85.4 | NR (95% CI, 20.3 to NR) | ||
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| Brigatinib | Breakthrough therapy designation | NCT01449461 | I/II | 79 | 62 | 13.2 |
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| ALTA | II | 222† | 45–55 | 8.8–15.6 | ||
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| Ensartinib (X-396) | Investigational | NCT01625234 | I/II | 27‡ | 70 | N/A |
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| Third Generation | ||||||
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| Lorlatinib | Investigational | NCT01970865 | I/II | 41§ | 46 | 11.4 |
*
Number of participants in the overall study population.
**
Enrolled ALK inhibitor-naive patients.
†
Participants were randomly assigned to either 90 or 180 mg of brigatinib.
‡
Includes eight crizotinib-naive patients.
§
Includes 26 patients previously treated with two or more ALK TKIs.
Abbreviations: ALK, anaplastic lymphoma kinase; NR, not reached; NSCLC, non-small cell lung cancer; ORR, objective response rate; PFS, progression-free survival; TKI, tyrosine kinase inhibitor.