Millennium Pharmaceuticals, Inc., along with co-development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) initiated Phase III clinical trial of Velcade 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 that showed high objective response rates and a favourable safety profile across a variety of lymphomas.
"We accelerated the timeline for initiating this high-priority trial," Robert Tepper, president, Research & Development, Millennium Pharmaceuticals, Inc. said adding, "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 enrol approximately 670 patients with relapsed or refractory, rituximab naïve or sensitive follicular NHL. Patients will be randomized to either the 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 as assessed by the International Workshop to Standardize Response Criteria for NHL (IWRC). The weekly dose of Velcade in this study is 1.6 mg/m2 and rituximab will be administered at 375 mg/m2.
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 US; Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. Velcade is approved in 66 countries worldwide. Velcade is also approved in the European Union as a second-line treatment.