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Study Supports Possible Use of Leukine(R) as a Potential Adjuvant Therapy for High-Risk Melanoma Patients

Friday, June 6, 2008 General News J E 4
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WAYNE, N.J., June 5 Results from an adjuvant trial inhigh-risk melanoma patients demonstrated that a majority of patients treatedwith Leukine(R) (sargramostim) achieved disease-free and/or overall survival.These findings, which indicate Leukine's potential in this cancer setting,were released at the 44th annual meeting of the American Society of ClinicalOncology (ASCO).

Results from the Phase II study (ASCO abstract #20027) show that 60percent of the 45 high-risk patients enrolled in the trial experienceddisease-free survival and 64 percent of patients achieved overall survival at21 months.

"Previous findings suggest that sargramostim may be a potential adjuvanttherapy for high-risk melanoma patients," said E. George Elias M.D., Ph.D.,Director of Maryland Melanoma Center. "The percentage of patients whoachieved disease-free and overall survival in this trial provides furtherevidence that sargramostim may prove to be a viable treatment option for thispatient population and that further study in Phase III trials are needed."

In this trial, adjuvant therapy with Leukine and a synergistic cytokine,IL-2, was generally well-tolerated in patients with high-risk melanomafollowing potentially curative surgery. Each patient received two years ofadjuvant therapy: year one with Leukine and IL-2 and year two with onlyLeukine. Toxicities were mild to moderate and no hospitalizations wererequired.

"These data, particularly the overall survival rates, are encouraging,even though preliminary, and indicate Leukine's potential as a treatment inthis setting," said Paul MacCarthy, M.D., FRCPI, vice president and head ofU.S. Medical Affairs for Bayer HealthCare Pharmaceuticals.

Clinical Trial Overview

This Phase II trial was a single-arm, open-labeled study to evaluate thesafety, tolerability and treatment efficacy of Leukine and IL-2 in 45 patientswho had undergone potentially curative surgery. In the first year oftreatment, Leukine was administered subcutaneously at 125mcg/m2/day for 14consecutive days, followed by IL-2 subcutaneously at nine million IU/m2/dayfor four days. The patients then received no treatment for 10 days. Patientswith resected large metastases that yielded approximately 100 X 106 tumorcells also received autologous whole cell vaccine starting at the secondLeukine cycle.

During the second year of treatment, each patient received Leukine alonetwo times per week. In patients who experienced resected recurrence, the sameadjuvant therapy was re-administered.

Follow-up ranged from one - 50 months (median 15.9). At the end of thetrial, 32 of the original 45 patients were alive [9/13 stage IV, 16/25 stageIII, and 7/7 stage II (3B/4C)]. The survival data were expressed by Kaplan-Meier, and showed disease-free survival of .60 [95 percent CI], and overallsurvival of .64 [95 percent CI] at 21 months. There was no statisticaldifference in survival by Log Rank between those who received only Leukineversus those treated by Leukine and IL-2 (p=.8), and there was no increase inthe number of dendritic cells during or after Leukine administration in the 11patients who donated blood for dendritic cell counts.

About Leukine(R)

Leukine(R) (sargramostim) is a growth factor that helps fight infectionand disease in appropriate patients by enhancing immune cell function.Leukine was approved in the United States in 1991, and is marketed by BayerHealthCare Pharmaceuticals. Leukine is the only growth factor approved in theU.S. for use following induction chemotherapy in older adults (greater than orequal to 55 years) with acute myelogenous leukemia (AML) to shorten the timeto neutrophil recovery and reduce the incidence of severe and life-threateninginfections and infections resulting in death. Leukine also has been approvedin the U.S. for use in four additional indications: myeloid reconstitution
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