Relatlimab/Nivolumab in Melanoma Improves Brain Metastasis–Free Survival
Source: Targeted Oncology, September 2024
Targeted Oncology: Could you describe the study design of the phase 3 RELATIVITY-047 study (NCT03470922)?
Ahmad Tarhini, MD, PhD: This was a first-line patient population with untreated metastatic melanoma who were randomly assigned 1:1 to a fixed-dose combination of nivolumab at 480 mg and relatlimab at 160 mg [Opdualag]. This was a fixed-dose single infusion on the study given over 60 minutes. Currently, it’s used mostly over 30 minutes. We give it over 30 minutes every 4 weeks in our practice. This was compared with nivolumab [Opdivo] 480 mg every 4 weeks as a single infusion. The primary end point was progression-free survival [PFS] by blinded independent central review [BICR], not investigator [assessment]. Secondary end points were overall survival [OS] and the objective response rate [ORR] by BICR.
What are the most recent data presented from this study?
The update presented by Hussein A. Tawbi, MD, PhD, at the American Society of Clinical Oncology Annual Meeting [ASCO] in June was the data lock of October 2023 at a median follow-up of 34 months.
The baseline patient characteristics…compared with CheckMate 067 [NCT01844505], which tested ipilimumab [Yervoy] plus nivolumab. If we look at [patients with] M1C and M1D disease, patients with visceral metastases or treated brain metastases, these were about 41% of the patient population on the study, similar to CheckMate 067. [Approximately] 36% of the patients had more than upper limit of normal for serum lactate dehydrogenase, also comparable with CheckMate 067. Looking at the PD-L1 expression, 59% of patients had PD-L1 [expression] less than 1%…and roughly 61.5% had BRAF wild-type, so [this was] a relatively high-risk patient population.