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|REVLIMID(R) (lenalidomide) Significantly Delays Time to Disease Progression in Previously Treated Multiple Myeloma Patients Presented at 2005 ASCO|
- Overwhelmingly Positive Statistically Significant Difference in The Primary Endpoint of Time-To-Progression (TTP) Demonstrated in Two Pivotal Phase III Special Protocol Assessment Trials (SPA) - Updated Clinical Data Presented at ASCO Scientific Symposium - The median time-to-disease progression in the North American Phase III Trial (MM-009) with REVLIMID plus dexamethasone was 60.1 weeks, compared with the median time-to-disease progression of 20.7 weeks for placebo plus dexamethasone (p=0.00000000000001) - The median time-to-disease progression in the International Phase III Trial (MM-010) with REVLIMID plus dexamethasone was 53.4 weeks, compared with median time-to-disease progression of 20.6 weeks for placebo plus dexamethasone (p=0.0000000000001) - Best response rate in the North American trial with REVLIMID plus dexamethasone was 61.2 percent, compared with a response rate of 22.8 percent for placebo plus dexamethasone; Complete response rate of REVLIMID plus dexamethasone was 26.5 percent, compared with 4.1 percent for placebo plus dexamethasone in the North American trial, based on Blade criteria - Best response rate in the International trial with REVLIMID plus dexamethasone was 58.0 percent, compared with a response rate of 21.7 percent for placebo plus dexamethasone; Complete response rate of REVLIMID plus dexamethasone was 13.6 percent, compared with 4.0 percent with placebo plus dexamethasone in the International trial, based on Blade criteria - In both trials, side effects were well characterized and manageable; the combination of REVLIMID and dexamethasone appeared to be well tolerated Celgene announced that it has completed and submitted its response to the FDA approvable letter for its THALOMID(R) supplemental new drug application for multiple myeloma
ORLANDO, Fla., May 15 /PRNewswire-FirstCall/ -- Celgene Corporation (Nasdaq: CELG) announced that REVLIMID(R) clinical data were presented at an ASCO Scientific Symposium on Sunday, May 15. The presentation provided updated results from the Pivotal Phase III Special Protocol Assessment (SPA) trials using REVLIMID in the treatment of previously treated patients with relapsed or refractory multiple myeloma. The studies reported overwhelmingly positive statistically significant difference in median TTP, the primary endpoint of the two trials. The analysis was based on clinical data available as of March 31, 2005. The median TTP for the North American trial (MM-009) was 60.1 weeks and for the International trial (MM-010) was 53.4 weeks. This is in contrast to the TTP for the placebo plus dexamethasone arms in which the median TTP was 20.7 weeks and 20.6 weeks, respectively.
Multiple myeloma is the second most common cancer of the blood, representing approximately one percent of all cancers and two percent of all cancer deaths with a reported worldwide prevalence of approximately 200,000 cases. In the year 2004, there were an estimated 74,000 new cases of multiple myeloma worldwide. The estimated number of deaths from multiple myeloma in 2005 was about 60,000 worldwide.
"The North American and International Multiple Myeloma Phase III trials reported a significant clinical benefit for patients treated with REVLIMID plus dexamethasone. In multiple myeloma patients with resistant disease, REVLIMID plus dexamethasone more than doubled the response rate compared with placebo plus dexamethasone confirming that REVLIMID has the potential to be an important new agent for multiple myeloma patients," explained Donna Weber, M.D., Associate Professor, Lymphoma/Myeloma of The University of Texas MD Anderson Cancer Center.
At the ASCO Scientific Symposium, Dr. Weber presented the results of the North American and International Multiple Myeloma Phase III trials. Dr. Weber led the North American Phase III trial (MM-009), a randomized, double-blinded, placebo-controlled trial, using REVLIMID plus dexamethasone, versus placebo plus dexamethasone in pretreated relapsed or refractory multiple myeloma patients. This study enrolled 354 patients from 47 clinical sites throughout North American with data available from 171 patients randomized to REVLIMID plus dexamethasone and 171 patients randomized to placebo plus dexamethasone. The median patient age was 64 years in the REVLIMID plus dexamethasone arm, compared to 62 years in the placebo plus dexamethasone arm of the trial. An Independent Data Monitoring Committee reviewed the planned interim analysis of clinical data and determined that the North American Phase III trial overwhelmingly exceeded the pre-specified efficacy stopping rule of p <0.0015 for the primary endpoint, time-to-disease progression. Consistent with the findings of the interim analysis, available as of March 31, showed best response rates of 61.2% in patients treated with REVLIMID(R) plus dexamethasone, compared to 22.8% of patients treated with placebo plus dexamethasone.
"Multiple myeloma is an illness with a discouraging outcome, but today, with advances such as REVLIMID, there is a prospect for myeloma to become a chronic illness for the majority of patients worldwide," explained Meletios Dimopoulos, M.D., Professor of Therapeutics at The University of Athens School of Medicine, Greece.
Dr. Dimopoulos led the International Phase III trial (MM-010), a randomized, double-blinded, placebo-controlled trial, using REVLIMID plus dexamethasone, versus placebo plus dexamethasone in previously treated relapsed or refractory multiple myeloma patients. This study enrolled 351 patients from 50 clinical sites internationally with data available from 176 patients randomized to REVLIMID plus dexamethasone and 175 patients randomized to placebo plus dexamethasone. The median patient age was 63 years in the REVLIMID plus dexamethasone arm, compared to 64 years in the placebo plus dexamethasone arm of the trial. An Independent Data Monitoring Committee reviewed the planned interim analysis and determined that this International Phase III trial overwhelmingly exceeded the pre-specified efficacy stopping rule of p< 0.0015 for the primary endpoint, time-to-disease progression. Consistent with the findings of the interim analysis, the available clinical data as of March 31, showed best response rates of 58.0% in patients treated with REVLIMID plus dexamethasone, compared to 21.7% of patients treated with placebo plus dexamethasone.
In both trials, patients treated with REVLIMID and dexamethasone had an increase in side effects as compared to those patients only treated with placebo plus dexamethasone. Grade 3 / 4 toxicities included neutropenia, thrombocytopenia and anemia. Deep vein thrombosis occurred in 13.5 and 4.5% of patients treated with REVLIMID plus dexamethasone, compared to 3.5 and 3.4% of patients treated with placebo plus dexamethasone in the North American and International trials, respectively. Pulmonary embolism occurred in 2.9 and 4.0% of patients treated with REVLIMID plus dexamethasone, compared to 0.6 and 1.1% of patients treated with placebo plus dexamethasone in the North American and International trials, respectively.
About the North American and International Phase III SPA Trials
These Phase III SPA studies were based on clinical data available up to March 31, 2005. These clinical data will continue to be accumulated and updated, through patient follow-up, on an ongoing basis. These trials were designed to investigate the effectiveness and safety of syncopated dosing of REVLIMID at 25mg combined with high-dose dexamethasone (HDD) compared with placebo and HDD in previously treated patients with multiple myeloma. These trials enrolled 705 patients and are being conducted in 97 sites internationally. REVLIMID and HDD are given in 28-day cycles REVLIMID 25 mg once daily on Days 1-21 every 28 days, and HDD 40 mg on Days 1-4, 9-12 and 17- 20 every 28 days. After four cycles the HDD schedule is reduced to 40 mg on Days 1-4 every 28 days). The primary endpoint of the study is time-to- progression calculated as the time from randomization to the first documentation of progressive disease based on Blade myeloma response criteria.
"We are pleased that the updated data from these Phase III trials were selected to be presented at such an important scientific symposium. These trials will be used as the basis for our regulatory submissions to the FDA and regulatory agencies around the world for REVLIMID(R) in previously treated multiple myeloma patients," said Jerome B. Zeldis, M.D., Ph.D., Chief Medical Officer and VP, Medical Affairs of Celgene Corporation. "Based on these positive results, the trials have been unblinded and all patients are being offered REVLIMID. Celgene is planning REVLIMID expanded access programs in the U.S. and a named patient program in Europe, for patients who have relapsed or refractory multiple myeloma."
REVLIMID is a member of a new class of novel immunomodulatory drugs, or IMiDs(R). Celgene is evaluating treatments with REVLIMID for a broad range of hematology and oncology conditions, including, multiple myeloma, the malignant blood cell disorders known as myelodysplastic syndromes as well as solid tumor cancers. REVLIMID affects multiple intracellular biological pathways. The IMiD pipeline, including REVLIMID, is covered by a comprehensive intellectual property estate of U.S. and foreign issued patents and pending patent applications including composition-of-matter and use patents.
REVLIMID is not approved by the FDA or any other regulatory agencies as a treatment in any indication and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.
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 remains unknown.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at http://www.celgene.com .
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation -0- 05/15/2005 R /CONTACT: Robert J. Hugin, Senior VP and CFO, +1-908-673-9102, or Brian P. Gill, Director PR/IR, +1-908-673-9530, both of Celgene Corporation / /Web site: http://www.celgene.com / (CELG) CO: Celgene Corporation ST: Florida IN: HEA BIO MTC SU: TDS R -- NYM169 -- 9787 05/16/2005 07:30 EDT http://www.prnewswire.com