Crizotinib

In an expansion cohort of a phase I study of crizotinib, 50 patients with advanced NSCLC who tested positive for ROS1 rearrangements were treated with oral crizotinib 250 mg twice daily.[43] ROS1 rearrangements were identified using break-apart FISH or reverse transcriptase−polymerase chain reaction assay. Seven patients (14%) had not had any previous treatment for advanced disease, 21 patients (42%) had one previous treatment, and 22 patients (44%) had more than one previous treatment. The primary end point was response rate.

In an expansion cohort of a phase I study of crizotinib, 50 patients with advanced NSCLC who tested positive for ROS1 rearrangements were treated with oral crizotinib 250 mg twice daily.[43] ROS1 rearrangements were identified using break-apart FISH or reverse transcriptase−polymerase chain reaction assay. Seven patients (14%) had not had any previous treatment for advanced disease, 21 patients (42%) had one previous treatment, and 22 patients (44%) had more than one previous treatment. The primary end point was response rate.

The overall response rate was 72% (95% CI, 58%–84%). Six percent of patients had a complete response, 66% had a partial response, and 18% had stable disease as their best response.

In an expansion cohort of a phase I study of crizotinib, 50 patients with advanced NSCLC who tested positive for ROS1 rearrangements were treated with oral crizotinib 250 mg twice daily.[43] ROS1 rearrangements were identified using break-apart FISH or reverse transcriptase−polymerase chain reaction assay. Seven patients (14%) had not had any previous treatment for advanced disease, 21 patients (42%) had one previous treatment, and 22 patients (44%) had more than one previous treatment. The primary end point was response rate.

Median PFS was 19.2 months (95% CI, 14.4–NR). The estimated DOR was 17.6 months (95% CI, 14.5–NR).[43][Level of evidence C3]

In a phase II, open-label, single-arm trial, 127 East Asian patients with NSCLC and ROS1 variants were treated with crizotinib 250 mg twice daily.[44] Twenty-four patients (18.9%) had not had any previous treatment for advanced disease, 53 patients (41.7%) had one previous treatment, and 50 patients (39%) had two or three previous treatments. The primary end point was objective response rate by independent review.

In a phase II, open-label, single-arm trial, 127 East Asian patients with NSCLC and ROS1 variants were treated with crizotinib 250 mg twice daily.[44] Twenty-four patients (18.9%) had not had any previous treatment for advanced disease, 53 patients (41.7%) had one previous treatment, and 50 patients (39%) had two or three previous treatments. The primary end point was objective response rate by independent review.

The objective response rate was 71.7% (95% CI, 63.0%–79.3%). Response rates were similar, irrespective of the number of previous therapies. Complete responses occurred in 13.4% of patients, while 58.3% of patients had partial responses and 16.5% of patients had stable disease as their best response.[44][Level of evidence C3]

In a phase II, open-label, single-arm trial, 127 East Asian patients with NSCLC and ROS1 variants were treated with crizotinib 250 mg twice daily.[44] Twenty-four patients (18.9%) had not had any previous treatment for advanced disease, 53 patients (41.7%) had one previous treatment, and 50 patients (39%) had two or three previous treatments. The primary end point was objective response rate by independent review.

Median PFS was 15.9 months (95% CI, 12.9–24). The DOR was 19.7 months (95% CI, 14.1–NR).

In a phase II, open-label, single-arm trial, 127 East Asian patients with NSCLC and ROS1 variants were treated with crizotinib 250 mg twice daily.[44] Twenty-four patients (18.9%) had not had any previous treatment for advanced disease, 53 patients (41.7%) had one previous treatment, and 50 patients (39%) had two or three previous treatments. The primary end point was objective response rate by independent review.

OS was 32.5 months (95% CI, 32.5–NR).