One-Year Overall Survival (Os) And Biomarker Correlates From A Phase Ii Study Of Ipilimumab (Ipi) With Carboplatin And Paclitaxel (Cp) In Patients With Unresectable Stage Iii Or Iv Metastatic Melanoma (Mm)

9062 Background: Pivotal studies with IPI demonstrated increased OS both as single agent (10.1 months) and with DTIC (11.2 months). We’ve previously reported an encouraging safety profile with IPI plus CP and early efficacy results. We now report updated 1-year OS and biomarker correlates of patient response. Methods: 30 patients were randomized in a 1:2 ratio to arm A (C (AUC = 6) and P (175mg/m2) every 3 weeks x 5 and IPI (3mg/kg) every 3 weeks x 4 starting at week 4) or arm B (similar dosing to arm A except IPI was given on week after CP). Tumor biopsies were collected at screening and week 8, and immune monitoring bloods were collected throughout. Results: Median OS was 16.1 months, with a 1-year OS of 56.5% for all patients with no differences between arms. Overall median follow-up was 23.2 months. Best overall response rate (BORR) and disease control rate (DCR) were 26.7% and 56.7% by irRC. BORR in patients whose tumors were wild type for BRAF and NRAS was 44%, compared to 8% in patients with a muta...