The advanced melanoma treatment landscape has significantly changed with approval of ipilimumab (IPI) and nivolumab (NIVO). This analysis aimed to describe real-world characteristics and treatment patterns of patients (pts) prescribed IPI, NIVO, or NIVO+IPI.
This interim analysis of an observational, retrospective, multisite study collected data for US pts diagnosed with unresectable or metastatic melanoma who received IPI, NIVO, or NIVO+IPI (index) between January 2015 and May 2016. Demographics and treatment patterns were abstracted from medical records through most recent visit (≥6 months). Data were descriptively reported.
Of 115 pts from 20 sites in the USA, 43 received IPI (mean±SD age 61.5±11.3 years, 51.2% female, 86.0% ECOG PS ≤ 1), 41 NIVO (age 65.9±13.7 years, 48.8% female, 90.3% ECOG PS ≤ 1), and 31 NIVO+IPI (age 57.1±11.3 years, 48.4% female, 100% ECOG PS ≤ 1). Tests for BRAF and PD-L1 were conducted in 98.3% and 39.1% of pts, respectively; 14.3%, 6.7%, and 12.2% of tested IPI, NIVO, and NIVO+IPI patients had a BRAF mutation, and 60%, 50%, and 79.0% of IPI, NIVO, and NIVO+IPI patients had a positive PD-L1 status. The index treatment was first line for 98.3% of pts; mean±SD days from advanced diagnosis to treatment initiation was 21.5±16.1 days for IPI, 55.1±68.6 for NIVO, and 41.5±68.6 for NIVO+IPI. The most common rationales for treatment initiation across treatments were improved efficacy (73.9%) and documented survival benefit (44.4%). Dose delays occurred in 9.3% of IPI pts (mean delay 12.7 days) and 6.5% of NIVO pts (mean delay 45 days); no NIVO+IPI pts had dose delays. At 6 months, 16% of pts remained on IPI, 85% remained on NIVO, and 71% remained on the NIVO portion of the NIVO+IPI regimen. Permanent discontinuation of treatment prior to completing planned courses of therapy was relatively infrequent (IPI: 16%, NIVO: 26%, NIVO+IPI: 19%), possibly reflecting improved experience in toxicity assessment and management.
Within this real-world cohort, a minority of pts discontinued NIVO or NIVO+IPI by 6 months. This research sheds light on current treatment patterns for IPI, NIVO, and their combination.
Clinical trial identification
Legal entity responsible for the study
A. Tarhini: Served as a consultant or advisor for Bristol-Myers Squibb; received institutional research funding from Amgen, Bristol-Myers Squibb, Incyte, MSD, Novartis, and Prometheus Laboratories. C. Macahilig: Employed by Medical Data Analytics, where she provides study design and data collection. C. Atzinger: Received personal fees from Bristol-Myers Squibb; employee of Pharmerit International. K. Gupte-Singh: Employee of Bristol-Myers Squibb and has stock/ownership in Bristol-Myers Squib. C. Solem: Institution received consulting fees from Bristol-Myers Squibb to conduct this research. S. Rao: Employed of Bristol-Myers Squibb and has stock/ownership in Bristol-Myers Squibb.