Nivolumab Superior to Ipilimumab for Melanoma Recurrence Prevention
The randomized phase 3 CheckMate 238 trial evaluated the safety and efficacy of nivolumab vs ipilimumab in the resected stage III/IV melanoma setting.
|The following article features coverage from the European Society of Medical Oncology (ESMO) 2017 Congress in Madrid, Spain. Click here to read more of Cancer Therapy Advisor's conference coverage.|
Nivolumab is superior to ipilimumab for recurrence prevention among patients with resected stage III or IV melanoma, according to data presented at the 2017 European Society of Medical Oncology (ESMO) meeting in Spain.1
Ipilimumab is approved in the United States for resected stage III disease. The randomized phase 3 CheckMate 238 trial (ClinicalTrials.gov Identifier: NCT02388906) evaluated the safety and efficacy of nivolumab vs ipilimumab in the resected stage III/IV setting.
Nine hundred and six patients were stratified and randomly assigned 1:1 to receive nivolumab (453 patients) or ipilimumab (453 patients). All patients were at least 15 years old and had a 5-year relapse risk of at least 50%.2
Median follow-up was 18 months. Median relapse-free survival (RFS) was not reached in either group, though the 18-month RFS rate was superior in the nivolumab group (66.4%) compared with the ipilimumab group (52.7%; log-rank P < .0001).
Ipilimumab also had a significantly worse adverse event (AE) profile, with grade 3 or 4 AEs occurring among 46% of patients receiving ipilimumab vs 14% for nivolumab. Only 10% of patients receiving nivolumab discontinued treatment because of an AE; this was true of 43% of patients receiving ipilimumab.
Two treatment-related deaths were reported for ipilimumab.
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The authors concluded that “[nivolumab] as adjuvant therapy significantly improved RFS vs [ipilimumab] for [patients] with stage III/IV melanoma at high risk of recurrence and demonstrated a superior safety profile.”
Read more of Cancer Therapy Advisor's coverage of the European Society of Medical Oncology (ESMO) 2017 Congress by visiting the conference page.
- Weber J, Mandala M, Del Vecchio M, et al. Adjuvant therapy with nivolumab (NIVO) versus ipilimumab (IPI) after complete resection of stage III/IV melanoma: a randomized, double-blind, phase 3 trial (CheckMate 238). Presented at: ESMO 2017 Congress; Madrid, Spain: September 8-12, 2017. Abstract LBA8_PR.
- Adjuvant nivolumab superior to ipilimumab in surgically resected stage III/IV melanoma [news release]. Lugano-Madrid, Spain: European Society of Medical Oncology; September 11, 2017. http://www.esmo.org/Press-Office/Press-Releases/Adjuvant-Nivolumab-Superior-to-Ipilimumab-in-Surgically-Resected-Stage-III-IV-Melanoma. Accessed September 12, 2017.