According to a recent study published online in the journal The Lancet Oncology, researchers have found that nivolumab led to a greater proportion of patients with advanced melanoma who progressed after anti-CTLA-4 treatment achieving an objective response and with fewer adverse events compared with investigator’s choice of chemotherapy (ICC)
For the study, researchers sought to compare nivolumab, a fully human IgG4 PD-1 immune checkpoint antibody approved by the U.S. Food and Drug Administration (FDA) for the treatment of melanoma and non-squamous cell lung cancer (NSCLC), to chemotherapy in patients with metastatic melanoma who have progressed after ipilimumab and/or a BRAF inhibitor.
Researchers randomly assigned 272 patients to nivolumab 3mg/kg every 2 weeks and 133 patients to ICC (dacarbazine 1000mg/m2 every 3 weeks or paclitaxel 175mg/m2 plus carboplatin AUC 6 every 3 weeks).
Results showed that 31.7% (95% CI: 23.5 – 40.8) of the first 120 patients treated with nivolumab achieved a confirmed objective response compared with 10.6% of 47 patients in the ICC group.
In regard to toxicity, the most common grade 3-4 adverse events associated with nivolumab treatment were lipase elevation, alanine aminotransferase elevation, anemia, and fatigue. In the ICC group, the most common were neutropenia, thrombocytopenia, and anemia.
- Weber JS, D’Angelo SP, Minor D, et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2015. [Epub ahead of print]. doi: 10.1016/S1470-2045(15)70076-8.