VELCADE(R) (Bortezomib) for Injection Showed Unprecedented Results In Newly Diagnosed Multiple Myeloma Patients
11:55 EDT Wednesday, June 21, 2006
-- Study published in journal Blood reports the highest complete response rate, similar to transplantation, with half achieving molecular remission --
CAMBRIDGE, Mass., June 21 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced results of a study that showed VELCADE in combination with melphalan and prednisone (V-MP) appeared significantly superior to melphalan and prednisone (MP) alone in treating elderly patients with newly diagnosed multiple myeloma (MM) who were ineligible for stem cell transplantation. The multi-center, Phase I/II study evaluating the safety and efficacy of VELCADE based therapy demonstrated an overall response rate of 89 percent, including a high complete and near complete response rate of 43 percent. This compared favorably to historical control data for MP, a widely used therapy that rarely induces complete response. Complete response is considered an important prognostic factor for survival.(1-2) The study was prepublished online in the journal, Blood, First Edition, June 13, 2006.
"Approximately half of patients presenting with multiple myeloma are elderly and not eligible for transplantation. New treatments that produce very high complete responses and molecular remissions are desperately needed," said lead investigator Jesus San Miguel, Professor of Medicine at the University Hospital in Salamanca, Spain. "With only one cycle of V-MP, we achieved a higher response rate than our historical controls of six cycles of MP and the proportion and quality of completed responses increased with subsequent cycles."
The open-label, dose-escalation study evaluated the safety and efficacy of V-MP in 60 newly diagnosed multiple myeloma patients between 65 and 85 years old, with almost half of all patients (47 percent) over 75 years old. An analysis from the study demonstrated:
* Overall response rate of 89 percent with 43 percent of patients
achieving complete (32 percent) or near-complete (11 percent) response
* In complete responders, half were immunophenotypic remissions as
analyzed by multiparameter flow cytometry (a highly sensitive method to
identify molecules associated with malignant cells)
* 91 percent were free of disease progression and event-free survival rate
was 83 percent compared to historical control data for MP of 66 percent
and 51 percent
* Median time to progression and overall survival not yet reached after a
median follow-up of 16 months
* Responses were independent of chromosomal abnormalities which generally
predict for poorer outcomes
* Treatment was well tolerated with a median of 42 weeks of treatment, a
duration of more than 9 months. Common adverse events were
gastrointestinal events, thrombocytopenia, neutropenia, fatigue and
peripheral neuropathy.
"The complete responses and deep molecular remissions in this V-MP study have never been reported in this treatment setting, highlighting the potency of VELCADE," said Robert Tepper, M.D., President, Research & Development, Millennium. "These results are similar to what you would expect to achieve in the transplant setting with a much more favorable safety profile."
The published study is the basis for an ongoing Company-sponsored, Phase III, international VISTA trial of VELCADE in combination with V-MP versus MP alone in patients with newly diagnosed multiple myeloma that are not transplant candidates. The data are also consistent with results in this elderly population observed in a subgroup analysis of the Phase III APEX trial, which investigated VELCADE treatment in patients with relapsed MM and included patients aged 65 years and older. VELCADE was found to be equally effective in elderly and younger patients -- the response rate did not differ substantially between the two groups. In addition, the overall incidence of adverse events was comparable across all age groups, indicating that VELCADE is equally tolerated in elderly and younger patients.(3) However, greater sensitivity in some older individuals cannot be ruled out.
Two additional, Phase III, multi-center trials being conducted by international cooperative groups are evaluating VELCADE based combinations in newly diagnosed patients who are eligible for transplantation. Collectively, these three front-line Phase III studies are anticipated to enroll approximately 2,000 patients and interim results from one of these is expected by the end of the year. |
