1106P International experience of ipilimumab and nivolumab in patients with advanced melanoma

Abstract

Immune checkpoint inhibition (ICI) combination therapy with ipilimumab (IPI) and nivolumab (NIVO), considered a standard of care for metastatic melanoma, has shown high rates of objective response rate (ORR), progression free survival (PFS) and overall survival (OS), but at a cost of significant toxicity. We aimed to analyse the efficacy and toxicity outcomes related to treatment with IPI and NIVO in routine practice in a multicentre cohort of patients (pts) with metastatic melanoma. We conducted a retrospective review of medical notes of pts with advanced melanoma (unresectable Stage 3 or Stage 4) treated with IPI and NIVO between 2015 and 2020 at 6 centers across Europe, USA and Australia. Baseline characteristics were collected including the presence of brain metastases (BM). The primary endpoint was OS in the non-BM cohort. Secondary endpoints were PFS, ORR and immune-related adverse events (irAE) in the whole cohort and BM pts only. 696 pts with median follow-up of 13 months (m) were included. Median age was 58 years, 400 (57%) were male, 678 (97%) had PS- ECOG 0-1. Primary site was cutaneous in 487 pts (70%), unknown in 133 pts (20%) and other (acral, mucosal and uveal) in 77 pts (10%). 352 pts (50.5%) had a BRAF mutation, 516 pts (74%) were treatment naive, 241 pts (35%) had BM, of which 131 (18%) were untreated. 277 pts (40%) had elevated LDH. ORR was 48% (95% CI, 45-52). Median PFS (mPFS) was 6m (95% CI, 4.3-7.6), median OS (mOS) was 38m (95% CI, 26.6-49.3) for the entire cohort. mOS in non-BM pts was 52 m (95% CI, NR-NR) and 14m (95% 5-23) in BM pts. Intracranial (IC) ORR was 43% (95% CI, 37-49) and IC disease-control-rate was 56% (95% CI, 49-62). 253 pts (36%) started maintenance NIVO. Any irAE occurred in 76% of pts; grade 3/4 in 44%, hospital admission rate was 36%, and 4 (0.7%) treatment-related deaths (1 pneumonitis, 2 myocarditis and 1 colitis) were recorded. The findings on this large cohort of pts support efficacy and provide insights into pts characteristics and outcomes associated with IPI and NIVO treatment for a heterogeneous population with advanced melanoma and are comparable with those of previously reported pivotal trial, Checkmate 067. Further analysis of the data including prognostic factors is ongoing.