ATLANTA, Dec. 9 /PRNewswire-FirstCall/ -- Pharmion Corporation today 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.
Thalidomide Data at ASH
Date / Time / Location: December 9, 2007; 4:30-6:00 p.m.; Rooms C303-C305, Georgia World Congress Center
Session: Myeloma: Firstline Phase III Trials in Multiple Myeloma -- Oral Presentation - 4:30 p.m.: Velcade-Thalidomide-Dexamethasone (VTD) vs Thalidomide-Dexamethasone (TD) in Preparation for Autologous Stem- Cell Transplantation (ASCT) in Newly Diagnosed Multiple Myeloma (Abstract #73). -- Oral Presentation - 5:00 p.m.: Melphalan-Prednisone-Thalidomide (MP-T) Demonstrates a Significant Survival Advantage in Elderly Patients .75 years with Multiple Myeloma Compared with Melphalan-Prednisone (MP) in a Randomized, Double-blind, Placebo-controlled Trial, IFM 01/01 (Abstract #75). -- Oral Presentation - 5:45 p.m.: Melphalan-Prednisone-Thalidomide to Newly Diagnosed Patients with Multiple Myeloma: A Placebo Controlled Randomized Phase 3 Trial (Abstract #78).
Date / Time / Location: December 10, 2007; 7:30-9:00 a.m.; Rooms C303- C305, Georgia World Congress Center
Session: Myeloma: Frontline Therapy in Newly Diagnosed Multiple Myeloma -- Oral Presentation - 7:45 a.m.: A Phase II Study of Velcade, Cyclophosphamide, Thalidomide and Dexamethasone as First-Line Therapy for Multiple Myeloma (Abstract #188).
Date / Time / Location: December 10, 2007; 1:30-3:00 p.m.; Rooms C306- C308, Georgia World Congress Center
Session: Autologous Transplantation for Myeloma: Induction, Mobilization, and Biologic Correlates
-- Oral Presentation - 2:00 p.m.: Incorporation of Thalidomide into Up- Front Double Autologous Stem Cell Transplantation (ASCT) for Multiple Myeloma Improves Outcome in Comparison with Double ASCT without Thalidomide. Analysis of Baseline Factors Predictive of Outcome (Abstract #447).
Date / Time / Location: December 10, 2007; 1:30-3:00 p.m.; Rooms C303- C305, Georgia World Congress Center
Session: Myeloma: Maintenance, Consolidation and Bone Disease in Multiple Myeloma
-- Oral Presentation - 1:45 p.m.: Consolidation with Bortezomib, Thalidomide, and Dexamethasone Induces Molecular Remissions in Autografted Multiple Myeloma Patients (Abstract #530). -- Oral Presentation - 2:15 p.m.: Thalidomide-Dexamethasone vs Interferon-Dexamethasone as Maintenance Treatment after ThaDD induction for Multiple Myeloma: Final Analysis of a Prospective, Randomized Study (Abstract #532).
Date / Time / Location: December 9, 2007; Viewing 9:00 a.m.-8:00 p.m., Presentation 6:00-8:00 p.m., Hall B4 of Georgia World Congress Center
Session: Myeloma: Relapsed and Refractory Multiple Myeloma -- Poster Board No. 915-II: Longer Duration of Thalidomide Monotherapy Results in Improved Outcome in Relapsed/refractory Multiple Myeloma (Abstract #2725). -- Poster Board No. 905-II: A Phase I/II Trial on Melphalan, Prednisone, Thalidomide, and Defribotide Combination in Relapsed/Refractory Multiple Myeloma Patients (Abstract #2715). -- Poster Board No. 908-II: Prolonged Progression Free Survival Does Not Relate to Quality of Response to Treatment with Thalidomide in Patients with Relapsed Multiple Myeloma (Abstract #2718). -- Poster Board No. 919-II: ThaDD-V Treatment for Patients with Relapsed/Refractory Multiple Myeloma: A Feasibility/Activity Study (Abstract #2729). -- Poster Board No. 924-II: Effect of Thrombotic Events on Overall Survival in Patients with Newly Diagnosed Myeloma: Analysis from a Randomized Phase III Trial of Thalidomide plus Dexamethasone vs Dexamethasone in Newly Diagnosed Multiple Myeloma (E1A00) (Abstract #2734).
Date / Time / Location: December 10, 2007; Viewing 10:30 a.m.-7:00 p.m., Presentation 5:00-7:00 p.m., Hall B4 of Georgia World Congress Center
Session: Myeloma: Novel Therapies -- Poster Board No 812-III: Thalidomide Combinations Improve Response Rates; Results from the MRC IX Study (Abstract 3593). About Thalidomide Pharmion
Thalidomide Pharmion is approved in Australia, New Zealand, Turkey, Israel, South Korea and Thailand for the treatment of multiple myeloma after the failure of standard therapies. In markets where Thalidomide Pharmion is not approved, such as the E.U., Thalidomide is currently provided by Pharmion on a named patient/compassionate use basis and under an Autorisation Temporaire d'Utilisation (ATU) in France while the Company seeks an approval. The European Medicines Agency (EMEA) has accepted for review the Company's Marketing Authorization Application (MAA) for the treatment of untreated multiple myeloma. Pharmion is the only provider of thalidomide outside of the US with a comprehensive safety program in place. The Company holds exclusive marketing and distribution rights from Celgene Corporation for Thalidomide in markets outside of North America, Japan and certain other Asian countries. In May 2006, Thalomid(R) (thalidomide) was approved by the U.S. Food and Drug Administration (FDA) in combination with dexamethasone for the treatment of newly diagnosed multiple myeloma.
Important Safety Information
Teratogenic effects: If Thalidomide is taken during pregnancy, it can cause severe birth defects or death to an unborn baby. A single dose (one capsule) taken by a pregnant woman during her pregnancy can cause severe birth defects. Thalidomide should never be used by women who are pregnant or could become pregnant.
The common adverse reactions associated with the use of Thalidomide in combination with other anti-myeloma therapies are: deep vein thrombosis, constipation, peripheral edema, tremor, dizziness, fatigue, asthenia, somnolence, peripheral neuropathy, neutropenia, lymphopenia, leucopenia, anemia, thrombocytopenia, paraesthesia and dysaesthesia. Serious or severe reactions associated with Thalidomide use are: deep vein thrombosis and pulmonary embolism, bradycardia, cerebrovascular accident, peritonitis, orthostatic hypotension, and severe skin reactions including Stevens Johnson Syndrome and toxic epidermal necrolysis. Thromboprophylaxis should be used when Thalidomide is prescribed in combination with other anti-myeloma therapies. Peripheral neuropathy is a potentially severe, adverse effect of treatment with Thalidomide that may result in irreversible damage. Thalidomide may also potentially aggravate existing neuropathy and should therefore not be used in patients with clinical signs or symptoms of peripheral neuropathy unless the clinical benefits outweigh the risks. Symptoms may occur some time after thalidomide treatment has been stopped and may resolve slowly or not at all. Thalidomide frequently causes drowsiness, somnolence and sedation. Patients should be instructed to avoid situations where drowsiness may be a problem.
About Multiple Myeloma
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease is unknown.
About Pharmion
Pharmion is a leading global oncology company uniquely focused on acquiring, developing and commercializing innovative products for the treatment of hematology and oncology patients in the U.S., Europe and additional international markets. Pharmion has a number of products on the market including the world's first approved epigenetic drug, Vidaza(R), a DNA demethylating agent. For additional information about Pharmion, please visit the company's website at http://www.pharmion.com/.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, including summary statements relating to the interim or preliminary results of clinical trials involving Thalidomide. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the final results to differ significantly from the results summarized by such statements. Preliminary results may not be confirmed upon final analysis of the detailed results of a trial and additional information relating to the safety, efficacy or tolerability of Thalidomide may be discovered upon further analysis of clinical trial data and upon review and analysis of additional clinical trial data from this or other clinical trials. Additional risks and uncertainties relating to Pharmion and its business can be found in the "Risk Factors" section of Pharmion's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2007, its Annual Report on Form 10-K for the year ended December 31, 2006 and in Pharmion's other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made, and Pharmion undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise. Pharmion also disclaims any duty to comment upon or correct information that may be contained in reports published by the investment community.
