Crizotinib: Updated Phase I data

Updated data from the expansion cohort of an open-label Phase I trial in 113 patients with advanced NSCLC carrying the ALK fusion gene showed that twice-daily 250 mg crizotinib produced a complete or partial response in 59 of 105 (56%) evaluable patients, with a median response duration of 36.3 weeks. Preliminary median progression-free survival (PFS) was 9.2 months at a median follow-up of 8 months. The most common adverse events were nausea, diarrhea, mild visual disturbances and vomiting. Data were presented at the European Society for Medical Oncology meeting in Milan. Pfizer previously reported data from 82 evaluable ALK-positive NSCLC patients showing that twice-daily 250 mg crizotinib, the MTD, produced an ORR of 57% and a DCR of 87% at week 8 (see BioCentury, June 14). ...