Moffitt Analysis Nivolumab Safety In Melanoma Patients

Source: Melanoma News Today, June 2015

During the the 2015 American Society of Clinical Oncology Annual Meeting in Chicago, Jeffrey S. Weber, M.D., Ph.D., director of the Donald A. Adam Comprehensive Melanoma Research Center at Moffitt Cancer Center presented the results from a retrospective analysis on the safety of nivolumab in 4 ongoing phase I-III studies in patients with melanoma. This monoclonal antibody was found to be an important therapeutic agent and was able to improve the survival rates of patients with melanoma.

Nivolumab can target the protein programmed death-1 (PD-1) receptor, which signals a pathway known to play a central role in regulating the immune system, preventing its activation. PD-1 is located on the surface of T-cells and PD-L1, its ligand, is expressed on antigen presenting cells. Binding of PD-L1 to PD-1 can inhibit immune cells’ activity and proliferation, preventing an efficient immunological response.

In patients with melanoma, tumour cells express increased levels of  PD-L1, avoiding detection by the immune system and increasing tumor survival.

The research team examined data on the safety of nivolumab in a sample of 576 patients who were treated with at least one dose of the drug agent. Adverse side events were low-grade and involved fatigue (25%), pruritus (17%), diarrhea (13%), and rash (13%). The results showed that 10% of the patients experienced grade 3/4 adverse drug-related events and prior treatment with ipilimumab, an CTLA-4 inhibitor had no impact in the incidence of later nivolumab-related adverse events.

The median time of symptoms’ resolution was of 3 weeks for hepatic adverse drug-related and 29 weeks for skin adverse drug-related events. In terms of response rates, 44% of the patients who were treated with an immunomodulatory (IM) agent for an adverse event responded to the drug versus 36% of those not treated with IM.