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Long-Term Data from a Landmark Phase III Trial Show Survival Benefit at Three- and Four-Years in Patients with Glioblastoma multiforme

Wednesday, October 31, 2007 General News J E 4
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LOS ANGELES, Oct. 30 Schering-Plough Corp. andthe European Organisation for the Research and Treatment of Cancer (EORTC)announced long-term follow-up results from the landmark Phase III trialconducted by the EORTC and the National Cancer Institute of Canada (NCIC) thatshowed the combination of TEMODAR (R) chemotherapy (temozolomide) Capsules andradiation therapy significantly prolonged survival in patients withglioblastoma multiforme (GBM) versus radiation treatment alone and that asurvival benefit remains with longer follow up. These data were presented atthe 49th Annual Meeting of the American Society for Therapeutic Radiology andOncology (ASTRO).

"In 2004, the data demonstrated that temozolomide therapy, taken duringand following radiation, offers significantly greater median overall survivalthan radiotherapy alone (14.6 versus 12.1 months, p less than 0.0001)," saidDr. Rene-Olivier Mirimanoff, professor and chairman, Department of RadiationOncology, University Hospital, Lausanne, Switzerland. "With longer follow-up,the data continue to show patients benefit from the combined therapy withpotential increased long-term survival outcomes."

In the study, the two-, three- and four-year survival rates for thecombination temozolomide/radiation therapy compared to radiation therapy alonewere respectively 27.2 percent versus 10.9 percent, 16.0 percent versus 4.4percent and 12.1 percent versus 3.0 percent.

"In 2004, the addition of temozolomide to radiotherapy demonstrated astatistically significant survival benefit with an oral therapy that has veryacceptable toxicity and a favorable benefit-risk profile," said Robert J.Spiegel, M.D., FACP, Chief Medical Officer and Senior Vice President,Schering-Plough Research Institute. "These follow-up survival findings shouldprovide further hope for patients and physicians fighting this terribledisease."

In the study, 573 patients were randomized between July 2000 and March2002. Patients between the ages of 18-70 years with newly diagnosed GBM wereeligible. Patients received either focal radiotherapy plus temozolomide at75mg/meters squared daily continuously for 42 (up to 49) days, followed by upto six cycles of adjuvant temozolomide (150-200 mg/meters squared daily forfive days every 28 days) or focal radiotherapy alone. Primary endpoint of thestudy was overall survival, with secondary endpoints of progression-freesurvival and quality of life. Initial study results presented in 2004 at theannual meeting of the American Society of Clinical Oncology and fullypublished in the New England Journal of Medicine in March 2005, found a medianoverall survival of 14.6 months in patients treated with TEMODAR concomitantlywith radiotherapy and then as maintenance treatment compared to a mediansurvival of 12.1 months in those treated with radiotherapy alone. The hazardration (HR) for overall survival was 0.63 (95 percent CI for HR equal to0.52-0.75) with a log-rank p less than 0.0001 in favor of the TEMODAR arm.

About Glioblastoma multiforme

Glioblastoma multiforme is a rapidly growing tumor of the central nervoussystem, most often located in the brain. It is the most common and deadliesttype of primary brain tumor. GBM is more common among males, particularly menbetween the ages of 40 and 60 years, and occurs more frequently in Caucasians.The overall annual incidence of primary malignant brain tumors is six to sevenper 100,000 people. (1)

Important Information Regarding U.S. Labeling for TEMODAR

TEMODAR(R) (temozolomide) Capsules are indicated for the treatment ofadult patients with newly diagnosed glioblastoma multiforme concomitantly withradiotherapy and then as maintenance treatment.

In newly diagnosed glioblastoma multiforme, during the concomitant phase(TEMODAR plus radiotherapy) side effects including thrombocytopenia, nausea,vomiting, anorexia and constip
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