Bayer reports strong results in Leukine trial

Germany's Bayer HealthCare reported positive data from a Phase II study of its Leukine (sargamostim) as an adjuvant treatment for high-risk melanoma, at the American Society of Clinical Oncology meeting in Chicago.

The single-arm, open-labeled study evaluated the safety, tolerability and treatment efficacy of Leukine with IL-2, a synergistic cytokine, in 45 subjects with high-risk melanoma who had undergone potentially curative surgery. Patients received two years of therapy, the first with Leukine and IL-2, and the second with Leukine alone. 60% of patients achieved disease-free survival, with 64% reaching overall survival after 21 months. The treatment was generally well-tolerated, with mild-to-moderate toxicities and no hospitilizations were required.

The company said that these results, though preliminary, were encouraging. George Elias, director of the Maryland Melanoma Center concurred and added that "Phase III trials are needed" for this indication.