Schering-Plough Corp's hepatitis C drug Pegintron helps stop the return of melanoma, the deadliest form of skin cancer, after surgery, reported Dutch researchers.
Results from a Phase III study published in The Lancet showed that patients with advanced melanoma who received Schering-Plough's PegIntron (pegylated interferon alfa-2b) had a lower risk of disease recurrence, compared with those who did not receive the drug. Findings from the study were originally presented at a medical conference last year.
Melanoma is an aggressive, difficult-to-treat cancer with a poor survival for people with advanced stages of the disease. Current therapies have only a limited impact or are highly toxic.
In the trial, 1256 patients with resected stage III melanoma were randomly assigned to PegIntron or observation, and the median length of treatment was 12 months. The findings showed that after a median follow-up of 3.8 years, patients who received Schering-Plough's drug had an 18-percent lower risk of disease recurrence, compared with those who did not receive the drug. "Prolonged treatment with pegylated interferon alfa-2b significantly improves recurrence-free survival compared with observation alone," commented lead author Alexander Eggermont.
People who received regular injections following surgery to remove their tumours had a 15 percent reduced risk of cancer recurrence after four years compared to melanoma patients who did not use the treatment, they found in a phase III clinical trial, the last step before a company can seek approval of a drug.
"The drug keeps tumours under control in a greater proportion of patients," said Alexander Eggermont, a cancer researcher at Erasmus University Medical Centre in Rotterdam, who led the study.
Nonetheless, more adverse events such as depression, liver toxicity and fatigue occurred in the group that was administered Schering-Plough's drug, and treatment with the product was discontinued in 31 percent of patients due to adverse events. In addition, treatment with PegIntron "was not associated with a benefit in overall survival," noted Schering-Plough spokesperson Cathy Cantone. The company said this result may be explained by the fact that the five-year study is not over. The drug has been submitted to regulators as a treatment for melanoma.