Adjuvant therapy with nivolumab versus ipilimumab after complete resection of stage III/IV melanoma: Updated results from a phase 3 trial (CheckMate 238)
Session type: Poster / e-Poster / Silent Theatre session
Previously, at 18 months' minimum follow-up, nivolumab demonstrated significantly longer recurrence-free survival (RFS) vs ipilimumab in patients with resected stage III/IV melanoma in the phase 3 CheckMate 238 trial. Here, we report updated 24-month efficacy results.
Eligible patients included those ≥15 years of age who underwent complete resection of stage IIIB/C or IV melanoma. 906 patients were randomized 1:1 (stratified by disease stage and 5% PD-L1 expression status) to receive nivolumab 3 mg/kg Q2W (N=453) or ipilimumab 10 mg/kg Q3W for 4 doses, then Q12W (N=453) for up to 1 year, or until disease recurrence or unacceptable toxicity. The primary endpoint was RFS with an exploratory endpoint of distant metastasis-free survival (DMFS).
At 24 months' follow-up, RFS remained significantly longer for nivolumab vs ipilimumab (hazard ratio 0.66, P<0.0001), with 171/453 vs 221/453 events, respectively. The patient subgroup 24-month RFS rates were higher for nivolumab vs ipilimumab (Table). DMFS remained significantly longer for nivolumab vs ipilimumab; 24-month rates were 70.5% and 63.7%, respectively (hazard ratio 0.76, P=0.034).
RFS, 24-month rates; % (N)
With extended follow-up, nivolumab demonstrated sustained efficacy benefit vs ipilimumab in patients with resected stage III/IV melanoma at high risk of recurrence, regardless of disease stage, PD-L1 expression, or BRAF mutation status. These results have been previously presented at the American Society for Clinical Oncology (ASCO) Annual Meeting, June 1-5, 2018, Chicago, IL, USA, and published in the conference proceedings (Abstract 9502).
This study was funded by Bristol-Myers Squibb. Medical writing assistance was provided by StemScientific.