Millennium, J&JPRD Begin Phase III Velcade Trial

Millennium Pharmaceuticals and Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) initiated a Phase III trial of Velcade in combination with Rituxan 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 that showed high objective response rates and a favorable safety profile across a variety of lymphomas.

The Phase III study is expected to enroll approximately 670 patients with relapsed or refractory, Rituxan naive or sensitive follicular NHL. Patients will be randomized to either the combination regimen of once-weekly Velcade plus Rituxan or Rituxan alone. The primary endpoint is progression-free survival. Secondary endpoints of the study include the overall response rate and duration of response as assessed by the International Workshop to Standardize Response Criteria for NHL (IWRC).

Previous trial results of Velcade in NHL showed overall response rates, including complete responses, of 54% in the weekly arm, and 51% in the twice-weekly arm with a similar total amount of drug received in both treatment arms. Additionally, data demonstrated response rates for single-agent Velcade as high as 56% in patients with relapsed or refractory follicular lymphoma.