NORTH HOLLYWOOD, California, and KOS, Greece, June 29 /PRNewswire/ --
- Data Presented at the 11th International Myeloma Workshop -
- Novel Therapies Including VELCADE(R) and REVLIMID(R) Lead the Way -
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(R) (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(R) (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(R) 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(R), a unique gene bank to
advance myeloma research. The IMF can be reached at +1-800-452-CURE or
http://www.myeloma.org, and in Spanish at http://www.myelomala.org.
Contact: Stephen Gendel
The International Myeloma Foundation
+1-212-918-4650
Web site: http://www.myeloma.org
http://www.myelomala.org
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