Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Nivolumab or Chemotherapy for Melanoma Treatment?

Interim analysis from the phase 3 CheckMate 037

In patients with advanced melanoma that has progressed after ipilimumab with or without a BRAF inhibitor, nivolumab may provide a better response with fewer toxic effects than alternative chemotherapy regimens, according to a phase 3 trial of 631 patients with unresectable or metastatic melanoma.

Researchers randomized patients to receive either 3 mg/kg of nivolumab intravenously every 2 weeks or the investigator's choice of chemotherapy (ICC), and found:

• Nivolumab offered a clinically meaningful durable objective response (31.7% vs. 10.6%).

• Adverse events associated with nivolumab included increased lipase, increased alanine aminotransferase, anemia, and fatigue.

• Adverse events associated with ICC included neutropenia, thrombocytopenia, and anemia.

Citation: 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. pii: S1470- 2045(15)70076-8. doi: 10.1016/S1470-2045(15)70076-8.