Fixed-dose combination (FDC) treatment with relatlimab and nivolumab prolongs progression-free survival (PFS), compared with nivolumab alone, in previously untreated patients with metastatic or unresectable melanoma, according to updated results of the phase 2/3 RELATIVITY-047 trial.
With extended follow-up, FDC relatlimab plus nivolumab led to a 22% reduction in the risk of progression or death. However, the combination did not improve overall survival (OS).
Georgia V. Long, MD, PhD, of the University of Sydney in Australia, presented these data in an American Society of Clinical Oncology (ASCO) Monthly Plenary Series presentation.
The RELATIVITY-047 trial (ClinicalTrials.gov Identifier: NCT03470922) included 714 patients with previously untreated, metastatic or unresectable melanoma. They were randomly assigned to receive FDC relatlimab-nivolumab (355 patients) or nivolumab alone (359 patients) intravenously every 4 weeks.
At a median follow-up of 19.3 months, the updated median PFS was 10.2 months in the relatlimab-nivolumab arm and 4.6 months in the nivolumab-alone arm (hazard ratio [HR], 0.78; 95% CI, 0.6-0.9).
The median OS was not reached in the relatlimab-nivolumab arm and was 34.1 months in the nivolumab-alone arm (HR, 0.80; 95% CI, 0.6-1.0; P =.0593).
Although the difference between the treatment arms was not statistically significant, relatlimab-nivolumab demonstrated a clinically meaningful improvement in OS over time, Dr Long noted. The OS rates were:
- 77.0% with relatlimab-nivolumab and 71.6% with nivolumab at 1 year
- 63.7% and 58.3%, respectively, at 2 years
- 55.8% and 48.8%, respectively, at 3 years.
The proportion of patients receiving subsequent systemic therapy was similar between the relatlimab-nivolumab arm (40.8%) and the nivolumab arm (42.6%).
The confirmed overall response rate was 43.1% with relatlimab-nivolumab and 32.6% with nivolumab alone. The complete response rate was 16.3% and 14.2%, respectively.
Grade 3-4 treatment-related adverse events (AEs) occurred in 21.1% of patients in the relatlimab-nivolumab arm and 11.1% of those in the nivolumab arm. There were 6 treatment-related deaths: 4 in the relatlimab-nivolumab arm and 2 in the nivolumab arm.
Immune-related AEs were more frequent in the relatlimab-nivolumab arm, the most common being hypothyroidism/thyroiditis (18.6%), rash (11%), and diarrhea (7%). AEs led to treatment discontinuation in 15.2% of patients in the relatlimab-nivolumab arm and 7.2% of patients in the nivolumab arm.
“These data further validate [nivolumab plus relatlimab] as a potential new treatment option in patients with advanced melanoma and support the benefit of dual checkpoint inhibition,” Dr Long concluded.
Disclosures: This research was sponsored by Bristol-Myers Squibb. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Long GV, Hodi FS, Lipson EJ, et al. Relatlimab and nivolumab versus nivolumab in previously untreated metastatic or unresectable melanoma: overall survival and response rates from RELATIVITY-047 (CA224-047). J Clin Oncol. 2022;40(36 suppl):Abstr 360385. doi:10.1200/JCO.2022.40.36_suppl.360385