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Investigational immunotherapy associated with high survival rate in advanced melanoma
Patients with advanced melanoma who underwent monotherapy with MK-3475 demonstrated excellent short-term survival outcomes, according to study results.
Eighty-one percent of patients were alive at 1 year.
The ongoing multicenter, open-label trial is designed to evaluate MK-3475 (Merck) — a highly selective, anti-PD–1 immunotherapy designed to restore the immune system’s ability to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein — in more than 1,000 patients with late-stage cancers.
Caroline Robert
Dosing regimens included 10 mg/kg every 2 weeks, 10 mg/kg every 3 weeks, and 2 mg/kg every 3 weeks. Overall response rate is the primary endpoint; PFS and OS are secondary endpoints.
The study includes 135 patients with advanced melanoma.
Among that cohort, the objective response rate — defined as patients who had either complete or partial response — across all doses improved with longer duration of follow-up, results showed. At the time of this analysis, researchers reported a 41% objective response rate, including a 9% complete response rate.
The majority of responses to MK-3475 occurred within 12 weeks of treatment; however, partial to complete response continued after 6 months of therapy and as late as 70 weeks. Median response duration or median OS has not been reached for all doses evaluated.
"New agents are needed for patients with advanced melanoma," researcher Caroline Robert, MD, PhD, head of dermatology at Institut Gustave Roussy in France, said in a press release. "I am excited by the results seen for MK-3475 as a single agent and believe these findings support further study both as a monotherapy and in combination in various solid tumors."
The FDA granted breakthrough therapy status to MK-3475. The designation is intended to expedite the approval process of drugs that may demonstrate substantial improvement over existing therapies for serious or life-threatening diseases.
Reference:
Robert C. Updated clinical efficacy and safety of MK-3475 (anti-PD-1 monoclonal antibody) in advanced melanoma. Presented at: Society for Melanoma Research 2013 Congress; Nov. 17-20, 2013; Philadelphia.
Disclosure:
See the full study for the researchers’ relevant financial disclosures.