Two-year results from the RELATIVITY-047 trial showed a stable benefit in progression-free survival (PFS), overall survival (OS), and overall response rate (ORR) with combination nivolumab plus relatlimab among patients with metastatic or unresectable melanoma .

These results were presented at the 2023 ASCO Annual Meeting by lead author Hussein A. Tawbi, MD, PhD, University of Texas MD Anderson Cancer Center, Houston, Texas. 

In this trial, patients were randomized on a 1-to-1 ratio to receive either nivolumab 480 mg and relatlimab 160 mg fixed-dose combination (n =355) or nivolumab 480 mg every four weeks.  This update includes descriptive analyses of efficacy and safety for approximately 2 years of follow-up (median follow-up duration 25.3 months). 

In this update, nivolumab plus relatlimab continued to present a benefit over nivolumab alone for PFS, OS, and ORR. A similar improvement was also observed in melanoma-specific survival. Nivolumab plus relatlimab was generally favored over nivolumab across key subgroups, which was consistent with previous reports. Future systemic therapy was received by 131, or 36.9%, patients in the nivolumab plus relatlimab arm and 136, or 37.9%, patients in the nivolumab arm.

Treatment-related adverse events of any grade which led to discontinuation were observed in 61 patients (17.2%) patients in the nivolumab plus relatlimab arm and 31 patients (8.6%) in the nivolumab arm. Grade 3/4 treatment-related adverse events were observed in 78 patients (22%) on nivolumab plus relatlimab and 43 patients (12%) patients on nivolumab alone. Overall, there were 6 treatment-related deaths.

Of this follow-up data, Dr Tawbi and colleagues concluded, “A consistent benefit was observed with [nivolumab plus relatlimab] vs [nivolumab] for PFS, OS, and ORR in the ITT population, as well as in key patient subgroups.”

Source:

Tawbi HA, Hodi FS, Lipson EJ, et al. Nivolumab (NIVO) plus relatlimab (RELA) vs NIVO in previously untreated metastatic or unresectable melanoma: 2-year results from RELATIVITY-047. Presented at 2023 ASCO Annual Meeting; June 2-6, 2023; Chicago, IL. Abstract 9502