Millennium Initiates Phase II Trial For Diffuse Large B-Cell Lymphoma

Business Wire

October 21, 2009

CAMBRIDGE, Mass. -- Millennium: The Takeda Oncology Company today announced the initiation of a Phase II clinical trial examining rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) with or without VELCADE(R) (bortezomib) for Injection for patients with a common type of lymphoma. The study will examine previously untreated patients with a genomically defined subtype of lymphoma called non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma.

The non-GCB genomic profile is an important, independent negative prognostic factor for patients with diffuse large B-cell lymphoma. Prior studies have indicated that patients with non-GCB type tumors do not respond well to R-CHOP therapy, which is the current standard of care in this disease setting. This open-label, randomized trial will evaluate whether the addition of VELCADE to R-CHOP (Vc-R-CHOP) improves progression-free survival in the non-GCB patient population.

"This innovative trial is one of our first studies investigating the potential of VELCADE in a genomically defined group of patients," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "Millennium was founded in genomic research. This study demonstrates how we've applied genomic knowledge in clinical trial design to enroll patients most likely to benefit from our therapies."

VELCADE is currently approved for use in patients with multiple myeloma and relapsed mantle cell lymphoma, a subtype of NHL. VELCADE has been used by more than 100,000 patients in more than 87 countries worldwide.

About Diffuse Large B-Cell Lymphoma

Diffuse large B-cell lymphoma is the most common form of non-Hodgkin's lymphoma (NHL) affecting approximately 50 percent of lymphoma patients. It is an aggressive form of NHL mostly affecting those above 50 years of age.

About VELCADE

VELCADE is 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., 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 more than 87 countries worldwide.

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