Long-Term Pegylated Interferon Alfa-2b Therapy in Stage III Melanoma Demonstrated Significant and Sustained Impact on Relapse-Free Survival
-- EORTC 18991 Phase III Study Results Presented At ASCO --
CHICAGO – June 2, 2007 – Long-term treatment with
pegylated interferon alfa-2b in stage III melanoma had a
significant and sustained impact on relapse-free survival (RFS),
according to the results of the largest adjuvant trial ever
conducted in patients with stage III melanoma. Results of the Phase
III study, led by the European Organisation for the Research and
Treatment of Cancer (EORTC) and supported by Schering-Plough, were
presented today by Alexander Eggermont, M.D., Ph.D. at the 43rd
Annual Meeting of the American Society of Clinical
Oncology.
“Advanced stage melanoma remains difficult to treat and a
need still exists to find treatment options,” said Alexander
Eggermont, M.D., Ph.D., lead investigator and head of the
department of surgical oncology, Erasmus University Medical Center,
Rotterdam, The Netherlands. “These findings demonstrate the
benefit of an increased relapse-free survival (RFS) despite no
difference in overall survival.”
Median RFS was 34.8 months in the pegylated interferon alfa-2b arm
vs. 25.5 months in the observational arm (p-value 0.01). Median
distant metastasis-free survival (DMFS) was 45.6 months in subjects
receiving pegylated interferon alfa-2b therapy versus 36.1 months
in observational arm (p-value 0.11).
The response to therapy appeared to be most pronounced in a
subgroup of subjects with only microscopic nodal involvement
(patients with positive sentinel node(s) who experienced both
increased relapse-free survival (RFS) (p-value 0.02) and distant
metastasis-free survival (DMFS) (p-value 0.03). This group of
patients constituted
43 percent of the trial population. At present, because of the
increased use of sentinel node staging , this patient population
largely constitutes the majority of patients diagnosed with stage
III disease.
In the study, participants reached a median 88 percent and 83
percent relative dose intensity, or percent of planned dose
intensity, during the induction and maintenance phases,
respectively. Forty percent (251 subjects) ceased pegylated
interferon alfa-2b therapy due to toxicity or patient’s
withdrawal of consent, while approximately 23 percent of subjects
continued into year 4 and 5 of treatment. Grade 3 or 4 toxicities,
mostly grade 3 in severity, were reported in 45 percent of subjects
in the pegylated interferon alfa-2b arm versus
12 percent in the observational arm. These events included
primarily Grade 3 fatigue, hepatotoxicity and depression. An ECOG
0-1 Performance Status was maintained in 83 percent of patients
during the maintenance phase. These data represent the planned
final analysis with a median follow-up of 3.8 years; study
participants will be followed for survival for a total of 10
years.
About the Study
This study was designed to assess the efficacy and safety of
long-term pegylated interferon alfa-2b vs. observation. Researchers
enrolled 1,256 subjects with stage III melanoma. Participants were
given pegylated interferon alfa-2b at a dose of 6 ?g/kg/week for an
eight week induction phase followed by 3 ?g/kg/wk (maintenance
phase), for total treatment duration of 5 years.
“We are pleased with the results of this important
study,” said Robert J. Spiegel, M.D., chief medical officer
and senior vice president, Schering-Plough Research
Institute. “Patient follow-up will continue to assess
long-term treatment with pegylated interferon alfa-2b and overall
survival.”
About Peg Interferon
Pegylated interferon alfa-2b is not approved in the United
States for treatment of melanoma. In the United States,
pegylated interferon alfa-2b is indicated for use alone or with
ribavirin for the treatment of chronic hepatitis C in patients with
compensated liver disease who have not been previously treated with
interferon alpha and who are at least 18 years of age.
Interferon is a protein produced naturally by white blood
cells that stimulates the growth of certain disease-fighting blood
cells in the immune system. Pegylated interferon is a longer-acting
form of interferon. It is made by attaching an inert molecule
called polyethylene glycol, or PEG, to the alpha interferon
molecule. This process increases the size of the interferon so it
is eliminated from the body more slowly. Pegylation allows for
once-weekly dosing rather than the three-times-weekly dosing
required for standard interferon.
Schering-Plough Corporation is a global science-based health care
company with leading prescription, consumer and animal health
products. Through internal research and collaborations with
partners, Schering-Plough discovers, develops, manufactures and
markets advanced drug therapies to meet important medical needs.
Schering-Plough's vision is to earn the trust of the physicians,
patients and customers served by its more than 33,500 people around
the world. The company's Web site is www.scheringplough.com.
Created in 1962, the European Organisation for Research and
Treatment of Cancer (EORTC) is a not-for-profit international
cancer research organisation under the Belgian Law. The EORTC has
the mission to develop, conduct, coordinate and stimulate
laboratory and clinical research in Europe to improve the
management of cancer and related problems by increasing survival
but also patients’ quality of life. The ultimate goal of the
EORTC is to improve the standard of cancer treatment in Europe,
through the development of new drugs and other innovative
approaches, and to test more effective therapeutic strategies,
using drugs which are already commercially available, or surgery or
radiotherapy.
The EORTC has the aim to facilitate the passage of experimental
discoveries into state-of-the-art treatment by keeping to a minimum
the time lapse between the discovery of new anti-cancer agents and
the implementation of their therapeutic benefit for patients with
cancer. The EORTC promotes multidisciplinary cancer research in
Europe and is linked to other leading biomedical research
organisations around the world. EORTC’s research takes place
in over 300 university hospitals in 32 countries and the unique
network of investigators of the EORTC comprises more than 2000
clinicians collaborating on a voluntary basis in 19
multidisciplinary groups. The EORTC Headquarters based in Brussels
consist of more than 150 researchers of 15 nationalities including
medical doctors, statisticians, data managers, quality of life
specialists, healthcare professionals and computer specialists as
well as research fellows and administrative staff.
The EORTC’s website is www.eortc.be
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including the potential market and prospects for pegylated interferon alfa-2b. Forward-looking statements relate to expectations or forecasts of future events. Actual results may vary materially from the forward-looking statements, and there are no guarantees about the performance of Schering-Plough stock or Schering-Plough's business. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ from Schering- Plough's forward-looking statements, including uncertainties in the regulatory process, market acceptance of pegylated interferon alfa-2b, manufacturing issues, current and future branded and generic competition, timing of trade buying, and difficulties in product development, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering- Plough's Securities and Exchange Commission filings, including item Part II, 1A. Risk Factors in the company's first quarter 2007 10-Q.
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