Phase 3 studies of Velcade for the treatment of follicular lymphoma (FL) and multiple myeloma (MM)

Millennium Pharmaceuticals reported results from two Phase 3 studies of Velcade (bortezomib injection); the first study compared Velcade and rituximab to rituximab monotherapy for the treatment of patients with relapsed or refractory follicular lymphoma (FL) who were rituximab-naïve or –sensitive, the second study compared subcutaneous to intravenous (IV) administration of Velcade in patients with relapsed multiple myeloma (MM).

The first trial for follicular lymphoma, was a randomized, international study enrolled 676 patients from 164 centers in 29 countries globally. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall response rate (ORR), complete response (CR) rate, time to next therapy (TTNT), and safety/tolerability. The results showed that patients receiving the Velcade-rituximab combination had a 22 percent improvement in PFS after a median follow-up of 34 months (hazard ratio=0.822, p=0.039). Median PFS was 12.8 months in the Velcade-rituximab arm, compared to 11 months with rituximab alone.

The second trial comparing IV and subcutaneous administered Velcade, was an open-label, international, non-inferiority study was conducted in 222 patients with relapsed MM and compared the overall response rates (ORR) after 12 weeks of treatment with subcutaneous or intravenous VELCADE. The secondary endpoints of the study included ORR after 24 weeks, time to tumor progression (TTP), progression free survival (PFS), one-year overall survival (OS) and safety and tolerability of the two routes of administration. The results showed that the efficacy of subcutaneous and intravenous Velcade was similar, and that subcutaneous Velcade appeared to be associated with an improved safety profile over intravenous Velcade.

Velcade is a powder for IV injection after reconstitution and presently indicated for the treatment of multiple myeloma and mantle cell lymphoma in patients who have received at least one prior therapy.

For more information call (800) 589-9005 or visit www.VELCADE.com.