Alectinib

A phase II open-label trial (NCT01871805) enrolled 87 patients with ALK-translocated stage IIIB/IV NSCLC who had disease progression after crizotinib treatment. The primary end point was objective response according to RECIST (version 1.1).[36]

A phase II open-label trial (NCT01871805) enrolled 87 patients with ALK-translocated stage IIIB/IV NSCLC who had disease progression after crizotinib treatment. The primary end point was objective response according to RECIST (version 1.1).[36]

At the time of primary end point analysis, 48% of patients (95% CI, 36%–60%) had a confirmed partial response, and 32% had stable disease by blinded independent review. The median DOR was 13.5 months (95% CI, 6.7–NE). The estimated median PFS was 8.1 months (95% CI, 6.2–12.6).[36][Level of evidence C3]

A phase II open-label trial (NCT01871805) enrolled 87 patients with ALK-translocated stage IIIB/IV NSCLC who had disease progression after crizotinib treatment. The primary end point was objective response according to RECIST (version 1.1).[36]

Sixteen patients had measurable CNS disease at baseline, of whom 11 had received prior radiation therapy. The CNS overall response rate was 75% (95% CI, 48%–93%), with 25% of the patients attaining complete response and 50% of the patients attaining partial response.

A phase II open-label trial (NCT01871805) enrolled 87 patients with ALK-translocated stage IIIB/IV NSCLC who had disease progression after crizotinib treatment. The primary end point was objective response according to RECIST (version 1.1).[36]

The most common side effects were grade 1 or 2 in severity; the most frequent adverse events, occurring in 23% to 36% of patients, were constipation, fatigue, myalgia, and peripheral edema. Dose interruption was needed in 36% of patients, and dose reduction occurred in 16%.

A second phase II, open-label trial enrolled 138 patients with stage IIIB/IV NSCLC and ALK variants who had disease progression while receiving crizotinib. The primary end point was objective response rate by independent central review.[37]

A second phase II, open-label trial enrolled 138 patients with stage IIIB/IV NSCLC and ALK variants who had disease progression while receiving crizotinib. The primary end point was objective response rate by independent central review.[37]

The objective response rate was 50% (95% CI, 41%–59%). Median DOR was 11.2 months (95% CI, 9.6–NR). Median PFS was 8.9 months (95% CI, 5.6–11.3).[37][Level of evidence C3]

A second phase II, open-label trial enrolled 138 patients with stage IIIB/IV NSCLC and ALK variants who had disease progression while receiving crizotinib. The primary end point was objective response rate by independent central review.[37]

CNS objective response rate in 35 patients with measurable CNS lesions was 57% (95% CI, 39%–74%).

A second phase II, open-label trial enrolled 138 patients with stage IIIB/IV NSCLC and ALK variants who had disease progression while receiving crizotinib. The primary end point was objective response rate by independent central review.[37]

Common adverse events that were mainly grade 1 or 2, which occurred in 25% to 33% of patients, were constipation, fatigue, and peripheral edema.