Velcade bortezomib: Phase III data

The open-label, international Phase III LYM3001 trial in 676 patients with relapsed or refractory, rituximab-naive or rituximab-sensitive follicular lymphoma showed Velcade plus rituximab met the primary endpoint of significantly improving median PFS vs. rituximab alone (389 vs. 334 days, p=0.039). Velcade plus rituximab also met the secondary endpoint of significantly improving ORR vs. rituximab alone (63% vs. 49%, p<0.001), with CR rates of 25% and 18%, respectively (p=0.035). Additionally, the combination significantly increased the durable response rate (>6 months; 50% vs. 38%, p=0.002) and median time to subsequent antilymphoma treatment vs. rituximab alone (700 vs. 537 days, p=0.027). Median OS has not yet been reached in either treatment group at a median follow-up of 33.9 months. Data will be presented at the American Society of Hematology meeting in Orlando in December. ...