Published February 29, 2024
| Version v1
Publication
Adjuvant Nivolumab versus Ipilimumab in Resected Stage III/IV Melanoma: 5-Year Efficacy and Biomarker Results from CheckMate 238
Description
lumab significantly improved recurrence-free survival (RFS) and
distant metastasis-free survival versus ipilimumab in patients with
resected stage IIIB–C or stage IVmelanoma,with benefit sustained at
4 years. We report updated 5-year efficacy and biomarker findings.
Patients and Methods: Patients with resected stage IIIB–C/IV
melanoma were stratified by stage and baseline programmed death
cell ligand 1 (PD-L1) expression and received nivolumab 3 mg/kg
every 2 weeks or ipilimumab 10 mg/kg every 3 weeks for four doses
and then every 12 weeks, both intravenously for 1 year until disease
recurrence, unacceptable toxicity, or withdrawal of consent. The
primary endpoint was RFS.
Results: At a minimum follow-up of 62 months, RFS with
nivolumab remained superior to ipilimumab (HR ¼ 0.72; 95%
confidence interval, 0.60–0.86; 5-year rates of 50% vs. 39%). Five year distant metastasis-free survival (DMFS) rates were 58% with
nivolumab versus 51% with ipilimumab. Five-year overall survival
(OS) rates were 76% with nivolumab and 72% with ipilimumab
(75% data maturity: 228 of 302 planned events). Higher levels of
tumor mutational burden (TMB), tumor PD-L1, intratumoral
CD8þ T cells and IFNg-associated gene expression signature, and
lower levels of peripheral serum C-reactive protein were associated
with improved RFS and OS with both nivolumab and ipilimumab,
albeit with limited clinically meaningful predictive value.
Conclusions: Nivolumab is a proven adjuvant treatment for
resected melanoma at high risk of recurrence, with sustained, long term improvement in RFS and DMFS compared with ipilimumab
and high OS rates. Identification of additional biomarkers is needed
to better predict treatment outcome.
See related commentary by Augustin
Additional details
Identifiers
- URL
- https://idus.us.es/handle//11441/155712
- URN
- urn:oai:idus.us.es:11441/155712