Millennium Pharmaceuticals, Inc. said its multiple myeloma (MM) drug Velcade helped eliminate the disease in a third of newly diagnosed patients.

The results presented were from the interim analysis of the first 256 patients evaluated in a multi-centre, randomised phase III clinical trial. This study compared Velcade, thalidomide and dexamethasone (VcTD) to thalidomide and dexamethasone (TD) alone, currently the most commonly used US regimen for patients with previously untreated multiple myeloma (MM). The trial was conducted by the Italian Myeloma Network (GIMEMA) cooperative group.

"This Velcade based induction regimen achieved a fourfold increase in the complete remission rate. Complete remission is widely recognized as a predictor for long-term survival," said Professor Michele Cavo, M.D., Seragnoli Institute of Hematology, University of Bologna and Principal Investigator of the trial. "These exciting results demonstrated that adding Velcade to the standard induction therapy prior to stem cell transplantation improves the response rate dramatically."

As induction therapy prior to stem cell transplantation (SCT), the VcTD arm demonstrated a complete remission (CR, including immunofixation-positive and negative) rate of 36 per cent compared to 9 per cent in the TD arm (p<0.001). Following transplantation, the VcTD arm demonstrated a complete remission (CR, including immunofixation positive and negative) rate of 57 per cent compared to 28 per cent in the TD arm (p<0.001). Successful stem cell mobilisation occurred in more than 90 per cent of patients in both arms

"We are excited to see that the Velcade combination continues to improve the complete remission rates of commonly used regimens to deliver significantly better results for patients," said Nancy Simonian, M.D., chief medical officer, Millennium. "This is one of the three Phase III front-line multiple myeloma trials presented at ASH that clearly establishes Velcade as a leading therapy for patients with previously untreated multiple myeloma."

Patients in the VcTD arm received VELCA$$DE at 1.3 mg/m(2) on days 1, 4, 8 and 11; dexamethasone at 40 mg each day of and after Velcade; thalidomide at 200 mg daily on a 21-day cycle for three cycles. Patients in the TD arm received dexamethasone at 40 mg on days 1 through 4 and 9 through 12 of every 21-day cycle and thalidomide up to 200 mg on a 21-day cycle for three cycles. The primary endpoint of the trial is CR to induction therapy and secondary endpoints include post-transplant CR, time-to-disease progression (TTP), event-free survival (EFS), overall survival (OS) and toxicity. VcTD was a well tolerated induction regimen with the incidence of grade two and grade three adverse events similar in each arm.

Multiple myeloma is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the median age of onset is 70 years of age), recent statistics indicate both increasing incidence and younger age of onset. In the US, more than 55,000 individuals have MM and 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.

Velcade is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialisation of Velcade in the US, Janssen-Cilag is responsible for commercialisation in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialisation in Japan. For a limited period of time, Millennium and Ortho Biotech Inc. are co-promoting Velcade in the US Velcade is approved in more than 85 countries worldwide.

In the US, Velcade is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy. Velcade is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Velcade is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. Velcade should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. In the European Union and many other countries worldwide, Velcade is approved for patients with multiple myeloma after first relapse.

Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets Velcade, a novel cancer product, and has a robust clinical development pipeline of product candidates. Millennium's research, development and commercialisation activities are focused in two therapeutic areas: oncology and inflammation.