Long-Term Pegylated Interferon Alfa-2b Therapy in Stage III Melanoma Demonstrated Significant and Sustained Impact on Relapse-Free Survival

ORTC 18991 Phase III Study Results Presented at ASCO

CHICAGO, IL, USA | 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(1), 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 microgram/kg/week for an eight week induction phase followed by 3 microgram/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 http://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 http://www.eortc.be

(1) Sentinel Lymph Node Biopsy: A surgical procedure that involves removing lymph tissue and examining it under a microscope for signs of cancer.

SOURCE Schering-Plough

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