Melanoma Drug Shows Manageable Side Effects

Nivolumab has increased the survival rate in patients with low grade adverse events.

A promising monoclonal antibody for the treatment of melanoma was found to have a manageable safety profile during a recent study.

Nivolumab, which targets the programmed death-1 (PD-1) receptor protein, has been found to improve the survival rate in melanoma patients. The PD-1 pathway controls the immune system by blocking inadvertent immune cell activation and autoimmune disease.

The protein is found on T cells, as the ligand PD-L1 is expressed on antigen presenting cells. Replication and immune cell activity is inhibited by the binding of PD-L1 to PD-1, which stops an immune response.

Melanoma cells show high levels of PD-L1 to avoid immune detection, which increases the survival potential of cancerous cells.

Researchers from the Moffitt Cancer Center examined data from 576 melanoma patients treated with at least 1 dose of nivolumab. The results showed that drug-related adverse events were primarily low-grade, with the most common adverse events reported as fatigue (25%), pruritus (17%), diarrhea (13%), and rash (13%).

The researchers found grade 3/4 adverse events in 10% of patients. The study showed that previous treatment with the CTLA-4 inhibitor ipilimumab did not impact adverse event incidence with nivolumab.

Immunomodulatory drugs were found to resolve toxicity in 166 out of 474 patients in phase 3 studies, while 114 patients received corticosteroids. Resolution of symptoms had a median time of resolution at 3 weeks for hepatic adverse events and 29 weeks for adverse events that affected the skin.

One patient out of 21 patients with a select grade 3/4 adverse event did not reach a resolution after treatment with immunomodulatory drugs, which also did not impact response rates.

The results showed 44% of patients treated with an immunomodulatory drug for an adverse event responded to therapy, while 36% of patients who were not treated with an immunomodulatory drug responded.