Velcade enters end-stage lymphoma trial

The trial will evaluate the drug in combination with rituximab in patients with relapsed or refractory follicular lymphoma, a subtype of non-Hodgkin’s lymphoma (NHL). This study builds on clinical data observed in previous trials of Velcade (bortezomib) that showed high objective response rates and a favorable safety profile across a variety of lymphomas.

“We accelerated the timeline for initiating this high-priority trial,” said Dr Robert Tepper, president of R&D at Millennium. “Based on previous study results that demonstrated substantial single-agent and combination activity in this patient population, we are excited about the potential of Velcade to benefit patients with this form of NHL, a disease that is not curable with standard therapy.”

The phase III study is expected to enroll approximately 670 patients with relapsed or refractory, rituximab naive or sensitive follicular NHL. Patients will receive a combination regimen of once-weekly Velcade plus rituximab or rituximab alone. The primary endpoint is progression-free survival. Secondary endpoints of the study include the overall response rate and duration of response.

Velcade is currently indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.