Table 1.
Drug | Study name or ClinicalTrials.gov identifier | Phase | Population | Comparator | n | ORR | PFS | Adverse effects or remarks |
---|---|---|---|---|---|---|---|---|
Crizotinib | PROFILE 1007 Shaw et al. [2013] | III | Platinum-based chemotherapy pretreated | Pemetrexed or docetaxel | 347 | 65% versus. 20% (p < .001) | 7.7 versus 3.0 months (HR: 0.49, 95% CI 0.37–0.64; p < .001) | Visual disorder (60%), diarrhoea (60%), nausea (55%), vomiting (47%), constipation (42%), elevated aminotransferase levels (38%), oedema (31%), fatigue (27%) |
PROFILE 1014 Solomon et al. [2014] | III | Treatment naïve, nonsquamous NSCLC | Platinum plus pemetrexed | 343 | 74% versus. 45% (p < .001) | 10.9 versus 7.0 months (HR 0.45, 95% CI 0.35–0.60; p < .001) | Visual disorder (71%), diarrhoea (61%), oedema (49%), vomiting (46%), constipation (43%), elevated aminotransferase levels (36%), upper respiratory infection (32%), abdominal pain (26%) | |
Ceritinib | ASCEND-1 Shaw et al. [2014] | I | Advanced malignancy* | No | 114 | 58% (95% CI 0.48–0.67) | 7.0 months (95% CI 5.6–9.5) | Nausea (82%), diarrhoea (75%), vomiting (65%), fatigue (47%), and increased ALT level (35%) |
NCT01685060 | II | Chemotherapy and crizotinib pretreated | No | NA | NA | NA | Ongoing clinical trial | |
NCT01685138 | II | Crizotinib-naïve | No | NA | NA | NA | Ongoing clinical trial | |
ASCEND-4 | III | Treatment naïve, nonsquamous NSCLC | Platinum plus pemetrexed | NA | NA | NA | Ongoing clinical trial | |
ASCEND-5 | III | Platinum-based chemotherapy and crizotinib pretreated | Pemetrexed or docetaxel | NA | NA | NA | Ongoing clinical trial | |
Alectinib$ | AF-001JP‡ Seto et al. [2013] | I/II | ALK-inhibitor-naïve | No | 46 | 93.5%, (95% CI 82.1–98.6) | NA | Dysgeusia (30%), increased AST level (28%), increased blood bilirubin level (28%), increased blood creatinine level (26%), rash (26%), constipation (24%), stomatitis (15%), and myalgia (13%). |
AF-002JGGadgeel et al. [2014] | I/II | Crizotinib pretreated | No | 47 | 55% | NA | Fatigue (30%), myalgia (17%), and peripheral oedema (15%) | |
NCT01871805 | II | Chemotherapy and crizotinib pretreated | No | NA | NA | NA | Ongoing clinical trial | |
ALEX | III | Treatment naïve | Crizotinib | NA | NA | NA | Ongoing clinical trial | |
AP26113 | NCT01449461 Gettinger et al. [2014b] | I/II | Crizotinib pretreated or ALK inhibitor naïve | No | 57 | Crizotinib pretreated: 69% (95% CI 54–81%) | Crizotinib pretreated: 10.9 months | Nausea (34%), diarrhoea (26%), fatigue (22%), and vomiting (16%) |
ALTA | II | Crizotinib pretreated | No | NA | NA | NA | Ongoing clinical trial |
Advanced malignancies were not restricted to NSCLC.
This drug was approved only in Japan as of September 2014.
This study was conducted in Japan with Japan Pharmaceutical Information Center, number JapicCTI-101264.
ALK, anaplastic lymphoma kinase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CI, confidence interval; HR, hazard ratio; NA, not available; ORR, overall response rate; PFS, progression-free survival.