North Hollywood, CALIFORNIA – September 4, 2014 – The International Myeloma Foundation (IMF) says newly published data confirm REVLIMID® (lenalidomide) plus low-dose dexamethasone (Rd) improves survival and other measures of efficacy, compared to MPT (melphalan, prednisone, and thalidomide), a standard of care for newly diagnosed multiple myeloma patients who are not eligible for a stem cell transplant. The study also demonstrates that continuing use of REVLIMID-dexamethasone instead of stopping after a fixed number of treatments provides further advantages in multiple measures including overall survival, progression-free survival, time to disease progression, overall response rate, and duration of response. The data from the phase III FIRST® (MM-020/IFM 07 01) trial are in the September 4th issue of the prestigious New England Journal of Medicine and expand upon the preliminary presentation of the study that was highlighted at the ASH 2013 global medical conference.
“This is an important study for newly diagnosed myeloma patients, especially elderly patients who are not eligible for transplant,” said Brian G.M. Durie, MD, Chairman and Co-Founder of the IMF. “REVLIMID as front-line treatment for myeloma is widely used in the United States. This sets the stage for approval in the US and Europe, and validates the use of continuous treatment beyond a fixed number of cycles in appropriate patients. What is especially important to note is the subjects in the study were older, with more advanced disease and poorer prognosis than previous phase III trials, and despite this, both frontline and continuous REVLIMID demonstrated impressive results.”
Specifically, the study demonstrated that continuous REVLIMID reduced the risk of disease progression by 28% and reduced the risk of dying by 22% compared to MPT in this higher-risk patient population. At three years, the overall survival rates were 70% with continuous REVLIMID-dexamethasone, 66% after a fixed 18 cycles of Rd, and 62% with MPT. At four years, the overall survival rates were 59%, 56%, and 51%, respectively. Patients receiving continuous REVLIMID did better than the other patients even when their disease progressed and a next-line therapy was required. The safety profile was manageable.
“This speaks to the advances made in treating myeloma with newer, more tolerable medicines that can be taken for years without diminishing a patient’s quality of life,” said Susie Novis, President and Co-Founder of the IMF. “With our Black Swan Research Initiative® we hope to be able to evaluate new therapeutics and combinations even faster as we move rapidly toward a cure.”
The study was led by Thierry Facon, MD, Professor of Hematology, Hôpital Claude Huriez and CHRU, Lille, France. The findings are consistent with other studies of these regimens, and additional follow-up will fully assess the survival benefit seen with continuous REVLIMID-based therapy.
ABOUT THE INTERNATIONAL MYELOMA FOUNDATION
Celebrating its 23rd anniversary, the International Myeloma Foundation reaches more than 350,000 members in 120 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 on four key areas: research, education, support, and advocacy. To date, the IMF has conducted more than 250 educational seminars worldwide, maintains a world-renowned hotline, and established the International Myeloma Working Group (IMWG), a collaborative research initiative focused on improving myeloma treatment options for patients. The IMF can be reached at (800) 452-CURE (2873). The global website is www.myeloma.org. Follow the IMF on Twitter @IMFmyeloma.