Millennium, Johnson & Johnson plan additional studies in response to Velcade results

New York, Dec. 12 - Millennium Pharmaceuticals, Inc. said it plans additional clinical studies of Velcade in response to findings from phase 2 research.

Presented at the 47th annual meeting of the American Society of Hematology in Atlanta, the phase 2 studies looked at the efficacy and safety of Velcade in patients with aggressive and indolent subtypes of non-Hodgkin's lymphoma.

They found high response rates, favorable safety and dosing with the drug as a single agent and in combination therapy.

"The efficacy and safety results presented here on Velcade alone and in combination with other standard therapies, such as rituximab, show the potential of Velcade to treat a broad range of lymphomas, including mantle cell and follicular lymphomas," said David Schenkein, senior vice president, clinical development at Millennium, in a news release.

"These findings have led Millennium and co-developer Johnson & Johnson Pharmaceutical Research & Development, to pursue additional clinical studies in non-Hodgkin's lymphoma, including a phase 3 trial of once-weekly Velcade plus rituximab versus rituximab alone in follicular lymphoma, expected to begin in the second half of 2006."

A randomized, multi-center phase 2 study led by Andre Goy of Hackensack University Medical Center in Hackensack, N.J., and Sven de Vos of UCLA Medical Center in Los Angeles evaluated weekly (1.6mg/m2) and twice-weekly (1.3mg/m2) dosing of Velcade in combination with the standard weekly dose of rituximab in patients with relapsed and refractory indolent B-cell lymphomas.

The more convenient weekly regimen showed a similar response rate to the twice-weekly arm with an improved safety profile, Millennium said.

For Velcade in combination with standard cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) plus rituximab, a phase 1/2 study of previously untreated patients with diffuse large B-cell and mantle cell lymphomas found a 95% overall response rate, including 85% showing complete response or complete response unconfirmed by biopsy. After an average of 13 months, 80% of patients were still alive. The findings were presented by John P. Leonard of Weill Medical College of Cornell University/New York Presbyterian Hospital in New York.

A phase 2 study of single-agent Velcade for Waldenstrom's macroglobulinemia by Steven Treon of Dana Farber Cancer Institute in Boston found an 85% response rate including 44% of patients achieving a major response and 41% achieving a minor response.

Millennium Pharmaceuticals is a Cambridge, Mass., biopharmaceutical company.

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