Survival and Longer Term Disease Control Take Precedence over Short Term Response to Treatment
North Hollywood, CA, and Atlanta, GA, December 10, 2007 - The International Myeloma Foundation (IMF)—supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians—today said new data being reported at a global cancer conference require a new approach to evaluating cancer treatments. Findings from a multi-center clinical trial sponsored by the National Cancer Institute and led by the Eastern Cooperative Oncology Group (ECOG) demonstrated that lowering the dose of the steroid dexamethasone when paired with REVLIMID® to treat newly diagnosed myeloma, not only reduces side effects, but also improves long-term survival. The data are being discussed and evaluated at the 49th annual meeting of the American Society of Hematology (ASH) in Atlanta.
According to the Mayo Clinic Cancer Center, lead institution for the study, the data show a "distinct survival benefit" with lower doses of the dexamethasone combined with REVLIMID. S. Vincent Rajkumar, M.D., hematologist and lead investigator of the study at the Mayo Clinic added, "This is a major advance in the treatment of cancer, and also gives researchers a new direction to explore – that more is not necessarily better when it comes to fighting the cancer."
The data showed REVLIMID, an oral medication from Celgene, plus low-dose dexamethasone improves one year survival compared to the standard high-dose dexamethasone, 96% to 88%. Over two years the benefit continues with an 87% survival rate for low-dose dexamethasone compared to a 75% survival rate for high-dose dexamethasone. While lowering the dose of the steroid also lowers some immediate measures of response that is offset by better, long-term disease control.
"Lowering the doses of the steroid dexamethasone with REVLIMID gives us a new paradigm of treatment," said Brian G.M. Durie, M.D., chairman and co-founder of the International Myeloma Foundation. "When we combine REVLIMID with lower dose dexamethasone, we are seeing reduced side effects so patients stay on the drug longer, and, above all, significant survival benefits. These are the outcomes that patients and physicians find most important, and take precedence over the traditional ways we have used to evaluate new therapies."
Last April the independent committee monitoring the trial found the preliminary results so compelling that the trial was stopped and all patients in the trial were moved to lower dose dexamethasone. Because of the overwhelming positive response to REVLIMID plus low-dose dexamethasone in the ECOG study, a trial from the other large cancer cooperative, SWOG, was also stopped prematurely. This trial compared REVLIMID plus high-dose dexamethasone to dexamethasone alone. Because this SWOG trial stopped early, and because nearly half of the patients on the dexamethasone-alone-arm of the study crossed over to the REVLIMID-plus-dexamethasone-arm of the study within the first year, overall impressions regarding survival could be misleading.
According to Dr. Durie: "We do not want patients confused by statistics. In fact, the SWOG trial concluded that REVLIMID with low-dose dexamethasone is among the most active up-front combination regimens against myeloma. These results demonstrate that REVLIMID plus dexamethasone is definitely better than dexamethasone alone, and is an excellent treatment in newly diagnosed multiple myeloma."
The International Myeloma Foundation concludes that overall findings presented at this conference about multiple myeloma in all ages, and across all categories of patients (newly diagnosed, relapsed, patients proceeding to bone marrow transplants and so on) is positive and encouraging and represents major advances in the treatment of blood cancers beginning with myeloma.
ABOUT The International Myeloma Foundation
The International Myeloma Foundation is the oldest and largest myeloma organization, reaching more than 165,000 members in 113 countries worldwide. A 501 (c) 3 non-profit organization dedicated to improving the quality of life of myeloma patients and their families, the IMF focuses in four key areas: research, education, support and advocacy. To date, the IMF has conducted more than 120 educational seminars worldwide, maintains a world-renowned hotline, and operates Bank on a Cure®, a unique gene bank to advance myeloma research. The IMF was rated as the number one resource for patients in an independent survey by the Target Research Group. The IMF can be reached at (800) 452-CURE, or out of the United States at +1 (818) 487-7455. More information is available at www.myeloma.org.
Media Contact: Stephen Gendel or Jennifer Anderson +1 (212) 918-4650