Table 2.
Efficacy of anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) as front-line therapy
| Drug | ORR (%) | Intracranial RR (measurable disease at baseline) |
mPFS (months) | Common AEs (>20%) | Dosing |
|---|---|---|---|---|---|
| Crizotinib [18] | 74 | 18% [22]a | 10.9 | Visual disturbances (71%), diarrhea (61%), edema (49%), vomiting (46%), constipation (43%), transaminitis (36%), abdominal pain (26%), dysgeusia (26%), headache (22%) | 250 mg PO BID |
| Ceritinib [40] | 72.5 | 72.7% | 16.6 | Diarrhea (85%), nausea (69%), vomiting (66%), transaminitis (55%), abdominal pain (25%) | 750 mg PO daily |
| Alectinib [44, 46] | 85 (J-ALEX) | 81% (ALEX) | NE (J-ALEX) | Constipation (35%)c | 300 mg PO BID (J-ALEX) |
| 82.9 (ALEX) | 25.7 (ALEX)b | 600 mg PO BID (ALEX) |
AEs adverse events, BID twice daily, mPFS median progression-free survival, NE not estimable, ORR overall response rate, PO orally, RR relative risk
a
From a retrospective review of PROFILE 1005 and PROFILE 1007; not reported in PROFILE 1014
b
25.7 months as assessed by an independent review committee, not reached as assessed by investigators
c
Reported in J-ALEX only