Ipilimumab (IPI) 10 mg/kg with sargramostim (GM-CSF; GM) improved overall survival (OS) and safety of patients with advanced melanoma over IPI in a randomized phase II trial. The FDA-approved dose of IPI 3 mg/kg has not been assessed with GM (IPI-GM). Consecutive patients treated with IPI-GM at a single institution were reviewed. Treatment included IPI every 3 weeks x 4 and GM 250 mcg subcutaneous injection days 1-14 of each IPI cycle. Efficacy, clinical characteristics, toxicities and blinded radiology review of tumor burden were evaluated. 32 patients were identified with 25 (78%) having irRC measurable disease and 41% with CNS metastases. 88.6% of GM doses were administered. Response rate by irRC and disease control rate at 12 weeks were 20% and 44%, respectively (median follow-up 37 weeks). Immune-related adverse events were observed in 10 (31.3%) patients, with 3 (9.4%) Grade 3 events. Patients with Grade 3 irAEs had prior autoimmunity, advanced age and poor performance status. The median OS from first dose of ipilimumab was 41 weeks. Ipi-GM treatment is feasible and in this poor-risk advanced melanoma population, efficacy appeared similar but safety appeared improved relative to historical IPI alone.
- Received March 10, 2015.
- Revision received April 8, 2015.
- Accepted April 23, 2015.
- Copyright © 2015, American Association for Cancer Research.