Therapeutic efficacy of Crizotinib

1. ALK- or ROS1-Positive Metastatic Non-Small Cell Lung Cancer

Previously Untreated ALK-Positive Metastatic NSCLC - Study 1 (PROFILE 1014; NCT01154140)

The efficacy of Crizotinib for the treatment of patients with ALK-positive metastatic NSCLC, who had not  received previous systemic treatment for advanced disease, was demonstrated in a randomized, multicenter,  open-label, active-controlled study (Study 1).

Study 1 demonstrated a statistically significant improvement in PFS in patients treated with Crizotinib. There  was no statistically significant difference in OS between patients treated with Crizotinib and patients treated  with chemotherapy. Table 16 and Figure 1 summarize the efficacy results. Exploratory patient-reported  symptom measures of baseline and post-treatment dyspnea, cough, and chest pain suggested a delay in time to  development of or worsening of dyspnea, but not cough or chest pain, in patients treated with Crizotinib as  compared to chemotherapy. The patient-reported delay in onset or worsening of dyspnea may be an  overestimation because patients were not blinded to treatment assignment.

from FDA，2023.09