--Data Presented at the 11th International Myeloma Workshop --
--Novel Therapies Including VELCADE® and REVLIMID® Lead the Way--
North Hollywood, CA, and Kos, Greece, June 28, 2007 -- The International Myeloma Foundation (IMF) - supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians - today said that updated statistics reported at the 11th International Myeloma Workshop in Greece demonstrate improved survival for a wide range of myeloma patients. Among the findings, in patients who had relapsed after one or more previous treatments:
- REVLIMID® (lenalidomide) plus the steroid dexamethasone showed an unprecedented median survival of nearly three years (35 months) for patients previously treated with multiple myeloma in updated data pooled from two large randomized controlled Phase III trials evaluating more than 700 patients from nearly 100 clinical sites worldwide.
- VELCADE® (bortezomib), combined with cyclophosphamide and prednisone in an open label Phase II trial evaluating 13 patients demonstrated an overall response rate of 93 percent. At one year, 100 percent of patients were alive.
- And combining VELCADE plus REVLIMID (with a steroid) showed a response rate of 68 percent in a pilot study of heavily pretreated patients.
"It was 15 years ago this month that my husband Brian Novis lost his battle with myeloma, and the progress since that time is truly remarkable," said Susie Novis, president and co-founder of the IMF. "Brian was diagnosed when he was just 33 years old and lived only four years past his diagnosis. Today we have multiple options for treatment, and for many patients survival is being measured in years, not months, with an excellent quality of life."
The International Myeloma Workshop brings together myeloma experts from all over the world to review the latest data and treatment protocols every two years.
VELCADE has been available to patients, who have relapsed after a previous treatment, in the United States since 2003 and in Europe since 2004. VELCADE as a single agent shows a median overall survival in this patient population of two and a half years (29.8 months) with "robust response rates" regardless of age. VELCADE in combination with DOXIL® was approved in May 2007. Data from a follow-up to a Phase 3 multi-national clinical trial shows that this combination further improves the probability of survival by 41%. Among the findings presented from an open label Phase I/II study evaluating 54 patients, when VELCADE is combined with melphalan and prednisone in newly diagnosed patients who do not go on to have transplants, survival was 85% the strongest 3 year survival rate demonstrated to date.
REVLIMID, an oral drug, is the newest of the novel therapies. This is the first conference since its European approval earlier this month; it is already approved in the United States for use in combination with dexamethasone as a treatment for multiple myeloma in patients who have been previously treated. Among the findings presented, in patients who have relapsed or not responded to a previous treatment, the 35 month median survival using REVLIMID in combination with dexamethasone has been characterized as the "highest response rate and longest overall survival" reported so far from two large randomized controlled Phase III trials that enrolled more than 700 patients worldwide. Importantly, it was previously reported that in patients newly diagnosed with multiple myeloma, in a large randomized Phase III trial evaluating more than 400 patients, REVLIMID with low dose dexamethasone demonstrated what has been called an "unprecedented" 98% one year survival in patients under 65 and 95% one year survival in patients 65 and over.
Combining these two powerful agents, VELCADE AND REVLIMID, produces "robust and durable" responses with improved tolerability, even in patients who had stopped responding to either drug when used alone. The data presented this week showed a 100 percent response rate in newly diagnosed patients and a 68 percent response rate in relapsed patients.
"The number of options available to treat myeloma patients today is growing with positive results from mature studies, as well as preliminary results from smaller trials," said Brian G.M. Durie, M.D. chairman and co-founder of the IMF. "What we are learning from using these novel combinations in myeloma is so promising that our findings may become applicable to many malignancies including lung, ovarian and other cancers. The progress we’ve begun in myeloma is encouraging for all cancer patients around the world."
Myeloma, also called multiple myeloma, is a cancer of cells in the bone marrow that affects production of red cells, white cells and stem cells. It affects an estimated 750,000 people worldwide, and in industrialized countries it is being diagnosed in growing numbers and in increasingly younger people.
ABOUT THE INTERNATIONAL MYELOMA FOUNDATION
The International Myeloma Foundation is the oldest and largest myeloma organization, reaching more than 135,000 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 can be reached at (800) 452-CURE or www.myeloma.org, and in Spanish at www.myelomala.org.