Dear Group,
The rate of progression on Gleevec is falling with time on the drug
with the lowest rate in the fifth year- only 0.6% in the chronic
phase. This means only 0.6% of patients in the IRIS trials progressed
in their disease to advanced phases in the fifth year. From CCR rate
of 69% in the first year of Gleevec, in the
fifth year, 87% of patients have a CCR on Gleevec from the IRIS
trials, showing that cytogenetic responses go on improving with
time. Where 50% of patients advanced to accelerated phase and blast
crisis pre-Gleevec in 3-5 years, 93% of chronic phase patients on
Gleevec remained free from progression to advanced phases and 83%
patients remained free from any relapse at all. Only 4.6% patients
died due to CML in 5 years of the Gleevec Phase III trials.
Best Wishes,
Anjana
Singapore
Gleevec(R) Sets New Treatment Standard in Chronic Myeloid Leukemia
With High Overall Survival, Increasing Response and Decreasing
Progression
- Nearly 90% of patients with Philadelphia chromosome-positive CML
alive at
5 years with new analysis showing less than 5% mortality due to
CML
- Response rate to Gleevec increases substantially over five years
in
landmark IRIS study, the largest ever conducted in CML patients
- Yearly rate of progression to more advanced disease continues to
drop the
longer patients take Gleevec, falling to 0.6% in fifth year
EAST HANOVER, N.J., June 3 /PRNewswire/ -- Response rates to
Gleevec(R)
(imatinib mesylate)* tablets continue to increase substantially over
time
while the yearly risk of progression to advanced disease continues to
decline the longer patients take the medicine, according to five-year
data
from a landmark study in patients with a form of life-threatening
chronic
myeloid leukemia.
Results of the International Randomized Interferon versus STI571
(IRIS)
study were presented today at the 2006 Annual Meeting of the American
Society of Clinical Oncology.
Data from the IRIS study, the largest clinical trial to date for
newly
diagnosed adult patients with Philadelphia chromosome-positive (Ph+)
chronic myeloid leukemia (CML) in chronic phase, showed the overall
survival rate at five years to be 89.4% (range 86% to 92%) for
patients
receiving Gleevec. This considers deaths from all causes, but only
4.6% of
the patients died from causes related to their leukemia. Before
Gleevec was
available, about 50% of patients progressed to the more advanced
stages of
Ph+ CML after only three to five years, and survival was generally
short
for those patients.
The results of this Phase III trial, which was started in June
2000,
also showed that the number of patients with a complete cytogenetic
response increased from 69% to 87% between the first and fifth years
of
treatment. Moreover, the yearly risk of progressing to advanced
disease
continued to decline -- to 0.6% in the fifth year.
"Very few oncology medicines offer patients the opportunity to
achieve
better outcomes the longer they take the therapy," said David Epstein,
President of Novartis Oncology. "That Gleevec demonstrates these
significant improvements with long-term use is a good sign science
will
provide the path to turn lethal cancers into potentially manageable
conditions with durable, well-tolerated targeted therapies."
An estimated 93% of Gleevec patients in the early, chronic phase
of CML
did not progress to the rapidly lethal advanced stages of the
disease, and
an estimated 83% survived with no evidence of disease progression at
all at
the five-year follow-up.
IRIS study details
The International Randomized Interferon versus STI571 (IRIS)
study is
an open-label Phase III clinical trial enrolling 1,106 newly diagnosed
patients with Ph+ CML in chronic phase in 177 centers across 16
countries.
There are two arms to the study: one group of patients receiving
Gleevec
400 mg per day and another receiving a target dose of interferon
(IFN) of 5
MIU/m2/day in combination with Ara-C 20 mg/m2/day for 10 days each
month.
Because of tolerability reasons or lack or loss of response to
treatment,
69% of patients in the IFN/Ara-C arm crossed over to the Gleevec arm,
whereas only 3% of patients in the Gleevec arm crossed over to the
IFN/Ara-C arm.
Cumulative best responses to Gleevec treatment improved
significantly
between the first and fifth years of treatment. Over the period,
complete
hematologic responses rose from 96% to 98%, major cytogenetic
responses
rose from 85% to 92% and complete cytogenetic responses rose from 69%
to
87%.
In a complete hematologic response, the patient's blood cell
counts
return to normal. Cytogenetic response refers to the disappearance or
reduction of the number of Ph+ cells detectable by standard lab
methods.
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