Bayer publishes Leukine trial results

Bayer HealthCare has published the results of a Phase II trial of its Leukine (sargramostim) in the July 1 edition of the Journal of Clinical Oncology.

The Phase II prospective trial evaluated 42 patients with resected high-risk (Stage IIIB, IIIC or IV) melanoma who were treated with Leukine (125mcg/m2/day) for 14 consecutive days followed by 14 days of no treatment. Results showed that the median overall survival was 65 months (95%, CI 43-67 months). Median recurrence-free survival was 5.6 months (95%, CI 3.7-11 months). Additionally, 11 patients who relapsed within three months of starting Leukine had lower dendritic cell counts at two weeks compared to those who relapsed after three months and those who remained in remission throughout the course of the study. However, the ability of Leukine to induce mature dendritic cells appeared to be confined to those patients who had a low dendritic cell count before the start of treatment.