Leukine As A Potential Adjuvant Therapy For High-Risk Melanoma Patients
Results from an adjuvant trial in high-risk melanoma patients demonstrated that a majority of patients treated with Leukine (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 Clinical Oncology (ASCO).
Results from the Phase II study (ASCO abstract #20027) show that 60 percent of the 45 high-risk patients enrolled in the trial experienced disease-free survival and 64 percent of patients achieved overall survival at 21 months.
"Previous findings suggest that sargramostim may be a potential adjuvant therapy for high-risk melanoma patients," said E. George Elias M.D., Ph.D., Director of Maryland Melanoma Center. "The percentage of patients who achieved disease-free and overall survival in this trial provides further evidence that sargramostim may prove to be a viable treatment option for this patient 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 melanoma following potentially curative surgery. Each patient received two years of adjuvant therapy: year one with Leukine and IL-2 and year two with only Leukine. Toxicities were mild to moderate and no hospitalizations were required.
"These data, particularly the overall survival rates, are encouraging, even though preliminary, and indicate Leukine's potential as a treatment in this setting," said Paul MacCarthy, M.D., FRCPI, vice president and head of U.S. Medical Affairs for Bayer HealthCare Pharmaceuticals.
Clinical Trial Overview
This Phase II trial was a single-arm, open-labeled study to evaluate the safety, tolerability and treatment efficacy of Leukine and IL-2 in 45 patients who had undergone potentially curative surgery. In the first year of treatment, Leukine was administered subcutaneously at 125mcg/m2/day for 14 consecutive days, followed by IL-2 subcutaneously at nine million IU/m2/day for four days. The patients then received no treatment for 10 days. Patients with resected large metastases that yielded approximately 100 X 106 tumor cells also received autologous whole cell vaccine starting at the second Leukine cycle.
During the second year of treatment, each patient received Leukine alone two times per week. In patients who experienced resected recurrence, the same adjuvant therapy was re-administered.
Follow-up ranged from one - 50 months (median 15.9). At the end of the trial, 32 of the original 45 patients were alive [9/13 stage IV, 16/25 stage III, 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 overall survival of .64 [95 percent CI] at 21 months. There was no statistical difference in survival by Log Rank between those who received only Leukine versus those treated by Leukine and IL-2 (p=.8), and there was no increase in the number of dendritic cells during or after Leukine administration in the 11 patients who donated blood for dendritic cell counts.