VELCADE(R) (Bortezomib) for Injection Based Therapy Substantially Improves Event-Free Survival and Complete Response Rate in Newly Diagnosed Multiple Myeloma Patients
Sunday June 3, 3:01 pm ET
Unprecedented 83 Percent Two-Year Event-Free Survival Achieved; Complete and Near Complete Response Rate of 84 Percent Maintained at Two Years
CHICAGO, IL--(MARKET WIRE)--Jun 3, 2007 -- Millennium Pharmaceuticals, Inc. (NasdaqGS:MLNM - News) today reported on results presented by the University of Arkansas for Medical Sciences and the Center for Cancer Research and Biostatistics on Total Therapy 3 (TT3). TT3, a treatment for newly diagnosed multiple myeloma patients, includes a VELCADE based therapy prior to and as maintenance following stem cell transplantation. These results showed a significant improvement over previously reported results from Total Therapy 2 (TT2), a current standard of care, which did not include VELCADE. The data were presented at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
"The inclusion of VELCADE in Total Therapy treatment substantially improves long-term patient outcomes and further supports VELCADE as an important therapy in the front-line treatment setting," said Bart Barlogie, M.D., Ph.D., Director, Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences. "While TT2 was successful, the VELCADE based combination achieved superior, statistically significant improvement in event-free survival and complete response rates."
Phase II Study of Total Therapy 3 (TT3) with Added Bortezomib (V) for Multiple Myeloma (MM) (Abstract #8020)
Dr. Barlogie presented results of this Phase II study in TT3 at two-year follow-up. Data showed:
-- A complete response (CR) and near complete response (nCR) rate of 84 percent with TT3, a statistically significant improvement over TT2 at 68 percent
-- An event-free survival of 83 percent with TT3, a statistically significant improvement over TT2 at 75 percent
-- A strong trend for improved overall survival in high-risk patients under the age of 65 for TT3 compared to TT2
-- Fewer patients on TT3, compared to TT2, experienced grade 3 and 4 side effects including tremor, constipation, syncope and thromboembolic events
The study included 303 patients. Patients received two cycles of a combination called VTD-PACE (VELCADE, thalidomide, dexamethasone, cisplatin, adriamycin, cyclophosphamide and etoposide) as induction therapy prior to and as consolidation therapy following stem cell transplantation. Patients were then given a combination of VTD (VELCADE, thalidomide and dexamethasone) once monthly for one year and a combination of TD (thalidomide and dexamethasone) once monthly for two additional years. The TT2 trial, presented at ASCO 2005, included 323 patients who received the same therapy without VELCADE. |
