Moffitt Cancer Center Takes Part in Newly Published Study in This Week's New England Journal of Medicine

TAMPA, Fla.--(BUSINESS WIRE)--Nov 21, 2007 - The Moffitt Cancer Center today said findings from the MM-009 Phase III trial show a statistically significant overall survival benefit for patients with multiple myeloma treated with REVLIMID plus dexamethasone. This study, along with another large, international trial evaluating REVLIMID, was published in this week's issue of the New England Journal of Medicine. In addition to increased survival, patients who received the oral cancer therapy in combination with the steroid dexamethasone also had increased response rates, time-to-disease progression and duration of response compared to patients treated with the steroid alone.

In the study, patients who received REVLIMID plus dexamethasone had an improved median overall survival time of 29.6 months compared to 20.2 months. The median time to progression was 11.1 months compared with 4.7 months in the placebo-dexamethasone group. Additionally, overall response rates in patients who received the REVLIMID combination was 61% with 24.3% of patients achieving complete/near complete response (compared to 19.9% and 1.7% respectively in the placebo group).

"We are excited about the impressive effect that REVLIMID demonstrated in multiple myeloma patients in whom previous therapies had stopped working," said Dr. Melissa Alsina, Associate Professor of Hematology at Moffitt Cancer Center and MM-009 study investigator, "These data are especially important for physicians as the need for new, potent treatment options grows due to the increasing number of diagnoses and prevalence of myeloma among younger patients."

Accompanying the articles in the New England Journal of Medicine was an editorial by Dr. Alan List, Professor of Oncology and Medicine and Chief, Division of Malignant Hematology at Moffitt, which discussed the development of REVLIMID as part of a new class of immunomodulatory drugs that carry a broad range of potential for a variety of blood cancers including multiple myeloma and myelodysplastic syndromes (MDS).

"REVLIMID has proven to be extremely effective in treating patients with multiple myeloma and MDS helping them to live longer, preventing disease progression and allowing them to have a better quality of life overall," said Dr. List. "This novel, oral cancer therapy carries exciting potential for patients across a broad range of blood cancers and it has been rewarding to see the effect that REVLIMID therapy is continuing to have for my patients after several years of treatment."

Myeloma, also called multiple myeloma, is a cancer of the bone marrow characterized by the uncontrolled growth of malignant plasma cells mainly in the bones, thereby causing bone damage. Normally plasma cells produce antibodies as a way the immune system has to fight infections. Therefore, patients with multiple myeloma have a weak immune system as well as low production of red cells. It is the second most prevalent of the blood cancers, affecting an estimated 750,000 people worldwide. Recent reports have shown that the incidence of myeloma is increasing despite a trend towards decreasing cancer rates over the past few years. Additionally, myeloma, once thought to be a rare disease of the elderly, is being diagnosed in younger people - with half of the patients diagnosed today being younger than 60, and the disease is increasingly being detected in patients under the age of 40.

MDS is a cancer in which the bone marrow fails to make enough functioning blood cells, either red blood cells, white blood cells or platelets. It is not known exactly how many people have MDS, however, about 20,000 to 25,000 new cases are diagnosed annually in the U.S.

REVLIMID (lenalidomide) from Celgene Corporation is the newest of what are called the novel therapies which have changed the outlook for myeloma patients. It is an oral drug that can be taken at home and doesn't have the difficult side effects associated with most chemotherapy because it targets the cancer cells directly along with the factors that support their growth. REVLIMID has been approved in combination with dexamethasone for patients who have received at least one prior therapy in the U.S. and Europe. Revlimid is also indicated in the U.S. for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

About Moffitt Cancer Center

Located in Tampa, Florida, Moffitt Cancer Center (www.moffitt.org) is the only Florida-based cancer center with the NCI designation as a Comprehensive Cancer Center for its excellence in research and contributions to clinical trials, prevention and cancer control. Moffitt currently has 15 affiliates in Florida, one in Georgia and two in Puerto Rico. Additionally, Moffitt is a member of the National Comprehensive Cancer Network, a prestigious alliance of the country's leading cancer centers, and is listed in U.S. News & World Report as one of "America's Best Hospitals" for cancer and ear, nose and throat. Moffitt's sole mission is to contribute to the prevention and cure of cancer.

Contact

Moffitt Cancer Center
Nancy Johnson, 813-745-1478
nancy.johnson@moffitt.org

Posted: November 2007

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