Millennium Pharmaceuticals, Inc. announced the initiation of a multi-centre, phase II trial to evaluate Velcade in combination with emerging agent, bendamustine, and current standard of care, rituximab, in patients with relapsed follicular lymphoma, a subset of non-Hodgkin's lymphoma (NHL). This trial is part of the company's comprehensive development program in NHL, which represents a significant growth opportunity for Velcade.
"We designed this trial to combine three active agents in NHL with the goal of enhancing the clinical outcomes of this patient population," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "We are hopeful this novel combination will add to the growing body of data that show the potential of Velcade to be part of the standard of care in follicular lymphoma, similar to what we've seen in multiple myeloma."
The primary endpoint of the open-label trial is complete remission with secondary endpoints including progression free survival and duration of remission. The trial is expected to enrol approximately 75 patients.
In previous studies, Velcade as a single-agent and as part of combination therapy has shown promising remission rates and time-to-disease progression in patients with NHL. These trials served as the basis for the Company to initiate the large, registration-enabling Phase III trial designed under a special protocol assessment (SPA) with the U.S. Food and Drug Administration (FDA) of Velcade and rituximab in patients with relapsed follicular lymphoma. The Company is on track to complete patient accrual in this phase III trial in the first half of 2008, with final data expected in 2010. Velcade is already approved by the FDA to treat relapsed mantle cell lymphoma (MCL). MCL is an aggressive, rapidly progressive subtype of NHL with median life expectancy for a patient with MCL, following first relapse, of one to two years.
Velcade is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of Velcade in the U.S. and Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. For a limited period of time, Millennium and Ortho Biotech Inc. are co- promoting Velcade in the US. Velcade is approved in 85 countries worldwide. More than 85,000 patients have been treated with Velcade globally.
In the US, Velcade is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy. Velcade is also indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Velcade is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. Velcade should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. In the European Union and many other countries worldwide, Velcade is approved for patients with multiple myeloma after first relapse.