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Millennium to start phase 3 trial of Velcade, rituximab combination for treatment of lymphoma
By Lisa Kerner
Erie, Pa., April 18 - Millennium Pharmaceuticals, Inc. and its co-development partner Johnson & Johnson Pharmaceutical Research & Development LLC began a phase 3 clinical trial of Velcade in combination with rituximab in patients with relapsed or refractory follicular lymphoma, a subtype of non-Hodgkin's lymphoma (NHL).
"We accelerated the timeline for initiating this high-priority trial," Millennium president of research and development Robert Tepper said in a company news release.
"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."
About 670 patients with relapsed or refractory rituximab naïve or sensitive follicular NHL will be enrolled in the randomized study.
The primary endpoint is progression-free survival, with secondary endpoints to include the overall response rate and duration of response as assessed by the International Workshop to Standardize Response Criteria for NHL.
Millennium said this latest study builds on previous clinical trial results of Velcade in NHL, including data from a phase 2 study comparing weekly and twice-weekly Velcade in combination with the standard-weekly dose of rituximab. The more convenient weekly arm showed a response rate similar to that of the twice-weekly arm, with an improved safety profile, the company said.
NHL, the most common hematological cancer and the fifth leading cause of cancer death in the United States, is responsible for 19,200 deaths annually, the release stated.
Millennium, a biopharmaceutical company based in Cambridge, Mass., researches, develops and commercializes products for oncology and inflammation.
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