Millennium says Velcade studies show up to 92% response rates in multiple myeloma

By E. Janene Geiss

Philadelphia, Dec. 13 - Millennium Pharmaceuticals, Inc. said Tuesday that results from studies exploring Velcade alone, or in combination with other commonly used agents, for previously untreated multiple myeloma showed overall response rates as high as 92% and complete response rates as high as 30%.

"These are among the best overall response and complete response rates seen to date for the treatment of newly-diagnosed multiple myeloma patients," Robert Tepper, president of research and development, said in a company news release.

"Multiple Velcade-based regimens with consistently high complete response rates provide evidence to support Velcade as the backbone of therapy," Tepper said.

A phase 1/ 2 trial evaluated the safety and efficacy of Velcade combined with melphalan and prednisone in previously untreated multiple myeloma patients 65 years of age and older. The phase 2 portion of the study with 53 evaluable patients demonstrated an overall response rate of 86% achieved after a median of five cycles of the regimen with 43% of patients achieving complete (30%) or near-complete (13%) responses, officials said.

In an update of a phase 2 trial, data on Velcade alone and in combination with dexamethasone in patients with previously untreated, symptomatic multiple myeloma showed an overall response rate of 90% for patients receiving a maximum of six cycles with response rates of 50% and 79% after two and four cycles, respectively.

And in a retrospective study that evaluated the safety and activity of Velcade in combination with thalidomide and dexamethasone in previously untreated multiple myeloma patients followed by autologous stem cell transplant, data showed an overall response rate of 92%, including a complete response rate of 18%, compared to an historical control overall response rate of 63%, including a complete response rate of 4%, observed with thalidomide and dexamethasone without Velcade, officials said.

These results were presented in independent oral presentations at the annual meeting of the American Society of Hematology held this week in Atlanta.

Velcade is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, LLC. Millennium is responsible for commercialization of Velcade in the United States. Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical is responsible for commercialization in Japan. Velcade is approved in more than 60 countries worldwide, including in the European Union, as a second-line treatment.

Millennium is a Cambridge, Mass., biopharmaceutical company focused on developing therapies for oncology and inflammation.

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