Xalkori crizotinib: Interim Phase II data

Interim data from 255 evaluable patients with ALK-positive NSCLC who have progressed after receiving >=1 chemotherapy in the open-label, international Phase II PROFILE 1005 trial showed that twice-daily 250 mg Xalkori given in 3-week cycles led to an ORR of 53%, a 12-week DCR of 85% and a median duration of response of 43 weeks. Median PFS was 8.5 months. In 439 patients evaluable for safety, the most common treatment-related adverse events were visual effects, nausea, vomiting and diarrhea. Treatment-related serious adverse events included dyspnea, pneumonitis, febrile neutropenia and renal cyst. Additionally, there was a significant >=10-point improvement from baseline in patient-reported overall pain, pain in chest, cough, dyspnea, insomnia, fatigue and quality of life (p<0.05). The trial is slated to enroll 800 patients. Data will be presented at the American Society of Clinical Oncology meeting in Chicago in June. ...