Thalidomide plus standard therapy improves survival in patients with multiple myeloma

07-05-2006

Pharmion Corp. (PHRM) reported that data presented at the 42nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, Georgia, demonstrates that the addition of thalidomide to standard therapy improves overall survival in patients with newly diagnosed multiple myeloma.

Data from a three-arm study, which was supported by Pharmion, in newly diagnosed, elderly (>65 years) multiple myeloma patients were presented at a plenary session on Sunday, June 4. The study was designed to compare overall survival in patients receiving standard therapy of melphalan and prednisone (MP), or standard therapy plus thalidomide (MP-T) or a combination of chemotherapies (vincristine/adriamycin/dexamethasone, or VAD) followed by melphalan and transplantation (MEL 100). A total of 447 patients were randomized to one of the three treatment arms.

Thalidomide was administered at doses up to 400mg according to patient tolerability. Following an August 2005 interim analysis, recruitment was stopped on the recommendation of the study's Data Safety Monitoring Board (DSMB).

At the time of analysis, the median overall survival in the MP-T arm was approximately 54 months, compared to 32 and 39 months, respectively, for the MP and MEL 100 arms. Thalidomide treatment was well-tolerated by the majority of patients. Thalidomide in combination with other treatments was associated with more venous thrombosis and pulmonary embolism. Patients taking thalidomide were also at more risk of peripheral neuropathy, neutropenia and constipation.

"These results are extremely encouraging news for patients with multiple myeloma," said professor Thierry Facon, from the Intergroupe Francophone du Myelome (IFM) and lead investigator of the study. "The study results confirm thalidomide as a beneficial treatment for newly-diagnosed multiple myeloma. Although current treatments can help to a certain extent, new treatments are still desperately needed for these patients and the results of this study show thalidomide could play an important role in helping patients to live longer."

"These powerful data represent a paradigm shift in the treatment options for newly diagnosed multiple myeloma patients," said Patrick J. Mahaffy, chief executive officer of Pharmion. "We look forward to working closely with the IFM and the EMEA to gain regulatory approval for thalidomide and to make this important treatment option available for patients in Europe."

The U.S. Food and Drug Administration (FDA) recently approved thalidomide, in combination with dexamethasone, for the treatment of newly-diagnosed multiple myeloma. However, the drug remains unapproved in Europe. Pharmion estimates that multiple myeloma affects approximately 82,000 people across Europe.

Pharmion is planning to submit a Marketing Authorization Application for thalidomide in the treatment of multiple myeloma to the European Medicines Agency (EMEA) by early 2007. The company expects this application will include data from four phase III clinical studies in patients with newly diagnosed multiple myeloma.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2006, Biotech Business Week via NewsRx.com.