New Data Show Median 30-Month Survival With VELCADE(R) (Bortezomib) for Injection in Relapsed Multiple Myeloma
- Single-agent data demonstrate six-month survival advantage over dexamethasone -
ATLANTA, Dec. 11 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals,Inc. (Nasdaq: MLNM) today announced extended survival data from the international, multi-center phase III APEX trial, the largest randomized study in relapsed myeloma, and the only trial to demonstrate a survival advantage
for a single agent, VELCADE, in this setting. The results demonstrate a six-month survival advantage for patients in the VELCADE arm. VELCADE demonstrated a median overall survival of 30 months. These findings were presented at the 47th Annual Meeting of the American Society of Hematology
being held December 10-13, 2005 in Atlanta, GA.
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"The survival benefit observed with VELCADE is a real milestone in a patient population for whom resistance to treatment and shortened survival constitutes a major challenge," said Paul Richardson, M.D., Dana-Farber Cancer
Institute in Boston and the lead investigator for the APEX trial. "The results support a number of clinical studies already underway to assess the potential of VELCADE as an initial therapy."
The updated results, based on median follow-up of 22 months, from the APEX study continue to show VELCADE is superior to high-dose dexamethasone in overall survival and one-year survival rates, response rates and time to
progression. The APEX trial was conducted at 93 centers in North America, Europe and Israel and enrolled 669 patients with multiple myeloma who had received one to three prior therapies.
Data from 669 evaluable patients showed:
-- Median overall survival was 30 months in the VELCADE arm versus 24 months in the dexamethasone arm providing a six-month survival advantage in the VELCADE arm
-- One-year survival was 80 percent in the VELCADE arm versus 67 percent in the dexamethasone arm
-- Importantly, statistical significance was maintained even though 62 percent of patients crossed over to receive VELCADE after experiencing progressive disease on the dexamethasone arm
Data from 333 evaluable patients in the VELCADE arm showed:
-- Overall response rate was 43 percent
- 16 percent had complete (nine percent) or near-complete (seven percent) response
- 34 percent had partial response
-- Responding patients received a median number of 10 cycles of treatment
-- In patients with 100 percent reduction of M-protein (measurement of disease), duration of response was longer (11.5 months)
-- Although median time to response remained rapid at 1.4 months, maximum reduction of M-protein occurred in later cycles of therapy, approximately:
- 20 percent of patients achieved best M-protein response after cycle 8
- 30 percent of patients achieved best M-protein response after cycle 6
- 50 percent of patients achieved best M-protein response after cycle 4
"These data build upon the impressive track record established by the eight-cycle VELCADE regimen in the phase II trials on which it was initially approved," David Schenkein, M.D., senior vice president, clinical development,
Millennium. "VELCADE is delivering on the promise to change the course of disease for myeloma patients."
About Multiple Myeloma (MM)
MM is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the average age of onset is 65 to 70 years of age), recent statistics indicate both increasing incidence and younger age of onset. In the United States, more than 45,000 to 50,000
individuals have MM and over 15,000 new cases are diagnosed each year.
Worldwide there are approximately 74,000 new cases and over 45,000 deaths due to MM each year(1).
About VELCADE
VELCADE is indicated for the treatment of multiple myeloma patients 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.
Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, hypotension observed throughout therapy, cardiac disorders, gastrointestinal adverse events, thrombocytopenia and tumor lysis syndrome.
Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE.
In 331 patients who were treated with VELCADE in a phase III study, the most commonly reported adverse events were asthenic conditions (61%), diarrhea (57%), nausea (57%), constipation (42%), peripheral neuropathy (36%), vomiting
(35%), pyrexia (35%), thrombocytopenia (35%), psychiatric disorders (35%), anorexia and appetite decreased (34%), parasthesia (27%), dysesthesia (27%), anemia and headache (26%), and cough (21%).
Fourteen percent of patients
reported at least one episode of grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia (4%), neutropenia (2%), and hypercalcemia (2%). A total of 144 patients on VELCADE (44%) reported serious adverse events
(SAEs) during the study. The most commonly reported SAEs were pyrexia (6%), diarrhea (5%), dyspnea, pneumonia (4%), and vomiting (3%).
VELCADE is being 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 60 countries worldwide. VELCADE is also approved in the European Union as a second-line treatment.
For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE (1-866-835-2233
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