Nivolumab Safer, More Effective Than Chemo for Advanced Melanoma

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Nivolumab led to a greater proportion of patients with advanced melanoma achieving an objective response and with fewer adverse events.
Nivolumab led to a greater proportion of patients with advanced melanoma achieving an objective response and with fewer adverse events.

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.

RELATED: FDA Grants Accelerated Approval for Opdivo in Melanoma

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.

Reference

  1. 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.

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