1104P Nivolumab (NIVO) monotherapy or combination therapy with ipilimumab (NIVO+IPI) in advanced melanoma patients with brain metastases: Real-world evidence from the German non-interventional study NICO

Abstract

Although melanoma brain metastases (MBM) have a relative incidence of 10%–40% in stage IV disease and often contribute directly to the cause of death, these patients are mostly excluded from prospective clinical studies due to their poor prognoses. Comparatively little is thus known about the effectiveness and tolerability of NIVO and NIVO+IPI in this vulnerable patient population, and real-world evidence for NIVO+IPI, a standard treatment option for MBM, is lacking for first and subsequent lines of therapy. NICO is a prospective, observational, multicenter study in Germany associated with ADOREG, assigned to enroll up to 750 patients with advanced melanoma who begin NIVO or NIVO+IPI treatment according to the marketing authorization. Patients will be followed for up to 5 years with assessments performed according to routine clinical practice. The primary objective is overall survival in patients receiving NIVO+IPI. Secondary objectives include overall survival in patients treated with NIVO, progression-free survival, safety profiles, adverse event management, treatment patterns, and patient-reported outcomes. Of all 623 patients (data cut 30/09/2019) enrolled with advanced melanoma, 64% received NIVO+IPI and 36% NIVO, compared with 74% and 27%, respectively, of patients with MBM (n = 175). NIVO+IPI was preferred over NIVO for patients with more advanced intracranial disease at baseline (MBM, 33.9 vs 21.1%) and who were younger (≤65 years, 62.1 vs 33.9%). For both treatment options, similar fractions of MBM patients were treated in the first (∼60%) and subsequent therapy lines (∼40%), with better responses for therapy-naïve patients (best overall response rate for NIVO+IPI, 31.0% vs 23.7%; NIVO, 26.9% vs 24%) by trend. The general safety profiles of both immuno-oncology therapies were confirmed. No new safety signals were observed. We present first real-world data from the second interim analysis of the NICO study in MBM patients treated with NIVO or NIVO+IPI in the first and subsequent treatment lines in routine care in Germany. Overall, both therapies provide effective and safe treatment options.