Thalidomide Prolongs Survival In Newly Diagnosed Multiple Myeloma Patients
Pharmion Corporation announced final data from a randomized, double-blind, placebo-controlled Phase 3 trial demonstrating that the addition of Thalidomide to standard treatment improves survival by 17.6 months in patients over age 75 newly diagnosed with multiple myeloma compared to standard treatment, consisting of melphalan-prednisone (MP), alone. These data, along with results from 12 additional studies of Thalidomide, are being presented at the 49th Annual Meeting and Exposition of the American Society of Hematology (ASH) in Atlanta.
"These data further demonstrate that the addition of Thalidomide to standard first-line therapy for patients with multiple myeloma, even relatively elderly patients, can provide a significant overall survival benefit," said Patrick J. Mahaffy, president and chief executive officer of Pharmion. "Data from this study are fully consistent with those previously announced and which form the basis of the Company's current marketing authorization application with the European regulatory authorities."
The Phase 3 dual-arm randomized study compared overall survival in patients receiving standard therapy of melphalan and prednisone plus placebo (MP-placebo) or standard therapy plus Thalidomide (MP-T). A total of 232 patients were randomized to one of the two treatment arms and 229 were analyzed for the presentation. In the analysis, the median overall survival in the MP-T arm was 45.3 months, compared to 27.7 months for the MP-placebo (p=0.033 log-rank test). Median progression-free survival was significantly higher in the MP-T arm, 24.1 months, compared to 19 months for the MP-placebo arm (p=0.001).
Though increased rates of peripheral neuropathy, neutropenia, and depression were observed in the MP-T arm of the study, no significant differences in rates of deep venous thrombosis or somnolence were found between the treatment arms. Toxicities in the MP-T arm were considered acceptable in this very elderly population.
"While the MP-T treatment regimen has become a standard treatment for newly diagnosed patients with multiple myeloma up to 75 years of age, those older than 75 represent more than 20 percent of myeloma patients, and are frequently excluded from large-scale clinical trials," said Cyrille Hulin, M.D., on behalf of the Intergroupe Francophone du Myelome and a principal investigator of the trial. "These are the first data to demonstrate the therapeutic benefit of the addition of thalidomide to MP for patients over age 75, which together with other recent data, demonstrate that MP-T therapy should become the reference treatment for all patients older than 65 years with newly-diagnosed multiple myeloma."
Pharmion submitted an application to the European Medicines Agency (EMEA) in January 2007 for a marketing authorization application for Thalidomide Pharmion in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged 65 years or older or ineligible for high dose chemotherapy.