| Alectinib | lung cancer (metastatic), in ALK positive patients | vs chemotherapy | progression or death (progression free survival PFS) by 85% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.15 [0.08 0.29] | p=0.04 | 0 | -18 | 1 | ALUR, |
| Trial | Studied treatment | Control | Patients |
|---|
| ALUR, 2018 | oral alectinib at a dose of 600 milligrams (mg) twice daily | chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously. | ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib |
| |
| Alectinib | | vs crizotinib | progression or death (progression free survival PFS) by 53% fully demonstrated | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| death (overall survival) | 0.76 [0.48 1.20] | p=1.00 | 0 | 303 | 1 | ALEX, | | progression or death (progression free survival PFS) | 0.47 [0.34 0.65] | p=0.04 | 0 | 303 | 1 | ALEX, |
| Trial | Studied treatment | Control | Patients |
|---|
| ALEX, 2017 | alectinib 600 mg orally (four 150 mg capsules) BID | Crizotinib | patients with stage IIIB or IV, ALK-positive NSCLC who had not received prior systemic therapy |
| |
| Ceritinib | lung cancer (metastatic), in ALK positive patients | vs chemotherapy | progression or death (progression free survival PFS) by 45% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| death (overall survival) | 0.73 [0.50 1.07] | p=1.00 | 0 | 376 | 1 | ASCEND-4, | | progression or death (progression free survival PFS) | 0.55 [0.42 0.73] | p=0.04 | 0 | 376 | 1 | ASCEND-4, |
| Trial | Studied treatment | Control | Patients |
|---|
| ASCEND-4, 2017 | oral ceritinib 750 mg/day | platinum-based chemotherapy ([cisplatin 75 mg/m2 or carboplatin AUC 5-6 plus pemetrexed 500 mg/m2] every 3 weeks for four cycles followed by maintenance pemetrexed | untreated patients with stage IIIB/IV ALK-rearranged non-squamous NSCLC |
| |
| Ceritinib | | vs pemetrexed or docetaxel | all NS | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| ASCEND 5, 2017 | Oral LDK378 750 mg once daily | pemetrexed or docetaxel | patients previously treated with chemotherapy (platinum doublet) and crizotinib |
| |
| Crizotinib | lung cancer (metastatic), in ALK positive patients | vs chemotherapy | progression or death (progression free survival PFS) by 53% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| death (overall survival) | 0.92 [0.69 1.23] | p=1.00 | 0 | 325 | 2 | Shaw, PROFILE 1014, | | progression or death (progression free survival PFS) | 0.47 [0.39 0.57] | p=0.04 | 0 | 325 | 2 | Shaw, PROFILE 1014, |
| Trial | Studied treatment | Control | Patients |
|---|
| Shaw, 2013 | crizotinib (250 mg) twice daily | intravenous chemotherapy with either pemetrexed (500 mg per square meter of body-surface area) or docetaxel (75 mg per square meter) every 3 weeks | patients with locally advanced or metastatic ALK-positive lung cancer who had received one prior platinum-based regimen | | PROFILE 1014, 2014 | oral crizotinib, at a dose of 250 mg twice daily | Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin | patients with advanced ALK-positive nonsquamous NSCLC who had
received no previous systemic treatment for advanced disease |
| |
