Patients with advanced Merkel cell carcinoma treated with Opdivo had improved disease-free survival rates compared with those who underwent observation.
Adjuvant therapy — or therapy given after primary treatment — with Opdivo (nivolumab) improved the rates at which patients with Merkel cell carcinoma, an aggressive skin cancer, survived without signs of the disease compared with observation, recent study findings demonstrated.
These results “might suggest clinical use of (Opdivo) in this area of unmet medical need,” the researchers wrote in the study published in The Lancet.
Relapse rates in patients with Merkel cell carcinoma are often high despite undergoing complete resection (surgical removal) and radiation, according to the study’s introduction. Therapies such as PD-1 and PD-L1 checkpoint inhibitors — both of which target specific proteins and releases the brakes on the immune system, allowing T cells to target and destroy cancer cells —have been shown to demonstrate a clinical benefit in patients with advanced Merkel cell carcinoma.
Researchers conducted this study to assess the safety and efficacy of Opdivo in patients with completely resected Merkel cell carcinoma, a setting which, according to the study, does not have “an established systemic standard-of-care treatment.”
In this phase 2 trial, researchers analyzed data from 179 patients with completely resected Merkel cell carcinoma lesions who were randomly assigned Opdivo (118 patients) or observation (61 patients). Of note, patients assigned Opdivo received the therapy every four weeks for one year.
The main focus of this study was to assess disease-free survival (the time after treatment when a patient survives without symptoms or signs of that cancer) at 12 months and 24 months. An outcome such as disease-free survival is meant to assess how well a treatment is working for a specific patient population.
Other areas of interest in this study included overall survival (the time when a patient with cancer is still alive) and safety. Follow-up was conducted for a median of 24.3 months.
Of the patients in the study, 65% had stage 3 to 4 disease, 68% were 65 years and older and 62% were men.
At follow-up, median disease-free survival was not reached, meaning that researchers could not calculate this information as more than half of patients did not experience any outcomes related to disease symptoms. At 12 months, 85% of patients assigned Opdivo were alive without signs or symptoms of cancer compared with 77% in those assigned observation. These rates at 24 months were 84% and 73%, respectively.
At the time researchers assessed overall survival, the data from patients were not mature, meaning there were not enough patients with sufficient information to calculate this.
Side effects considered severe or life-threatening occurred in 48 out of the 115 patients (42%) who received at least one dose of Opdivo compared with seven out of the 61 patients (11%) assigned observation. No deaths related to treatment were reported during the study.
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