Does Combination Immunotherapy Improve Survival in Metastatic Uveal Melanoma?
Posted: Wednesday, August 21, 2019
According to the results of a phase II single-arm study investigating ipilimumab and nivolumab for patients with metastatic uveal melanoma presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 9522), the combination immunotherapy regimen led to stable disease for a majority of patients. Meredith Pelster, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues also performed preliminary translational tumor work on a subset of responders.
In this clinical trial (ClinicalTrials.gov identifier NCT01585194), the authors enrolled patients with at least one measurable lesion and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients were enrolled regardless of the number of prior treatments and received 1 mg/kg intravenously of nivolumab plus 3 mg/kg intravenously of ipilimumab every 3 weeks, for a total of 4 doses. Additionally, maintenance nivolumab was administered every 2 weeks at 3 mg/kg or every 4 weeks at 480 mg intravenously. At the data cutoff, a total of 39 patients were enrolled, 35 received at least one treatment and were evaluable for toxicity, and 30 were ultimately evaluable for efficacy.
After a median follow-up of 60.5 weeks, 19 patients (63%) had completed all four cycles of nivolumab with ipilimumab. Within the group, 16 patients experienced stable disease (53%), 9 underwent progression of disease (30%), and 5 sustained a partial response (17%). The investigators found that eight patients had stable disease for at least 6 months. The median progression-free survival of the cohort was 26 weeks, with a 1-year overall survival rate of 62% and a median overall survival of 1.6 years (or 83 weeks).
Most study patients experienced an adverse event (91%) or treatment-related adverse event (83%). Grade 3 and 4 treatment-related adverse events occurred in 14 patients (40%), and 10 patients (29%) had to be removed from the study because of adverse events.
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.