Table 2. Activity of ALK inhibitors in patients with ALK-rearranged NSCLC with brain metastases.
| ALK-inhibitor | Clinical trial | No. of patients with brain METS/No. of patients without RT | IC-ORR/IC-DCR (untreated with RT) | IC-ORR/IC-DCR (all patients) |
|---|---|---|---|---|
| Crizotinib | PROFILE1005/PROFILE1007 | 275/109 | 18%/56% | 33%/62% |
| PROFILE1014 | 79/0 | NR/NR | NR/85% | |
| Ceritinib (LDK378) | ASCEND-1 | 124/23 | 43%/NR | 36%/65% |
| ASCEND-2 | 100/28 | NR/NR | 39.4%/64% | |
| ASCEND-3 | 50/23 | NR/NR | 58.8%/78% | |
| ASCEND-4 | 54/32 | 46.9%/43.8% | 46.3%/42.6% | |
| ASCEND-5 | 17/0 | NR/NR | 35%/NR | |
| Alectinib (CH5424802/RO5424802) | AF-002JG | 21/47 | 75%/100% | 52%/80% |
| NP28761 | 52/18 | 67%/NR | 75%/63% | |
| NP28673 | 84/23 | 53%/NR | 57%/83% | |
| ALEX | 64/NR | NR/NR | 59%/NR | |
| ALUR | 72/NR | NR/NR | 54.2%/NR | |
| Brigatinib (AP26113) | NCT01449461 | 52/25 | 67%/NR | 53%/55% |
| ALTA | 40/0 | NR/NR | 42% in 90 mg, 67% in 180 mg | |
| Lorlatinib | NCT01970865 | 30/50 | NR/NR | 33% |
| Ensartinib (X-396) | NCT01625234 | 60/60 | NR/NR | 65% |
ALK, anaplastic lymphoma kinase; NSCLC, non-small cell lung cancer; IC-ORR, intracranial overall response rate; IC-DCR, intracranial disease control rate.