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Long-term survival results after 5 years of ipilimumab therapy in patients with advanced melanoma shows promise.
Long-term survival results after 5 years of ipilimumab therapy in patients with advanced melanoma shows promise.
A global collaboration of researchers in the United States, Italy, Germany, and France reported overall results of a 5-year trial of combination treatment with the immunotherapy ipilimumab and the chemotherapeutic drug dacarbazine in patients with advanced melanoma.
Results were presented ahead of publication at the European Cancer Congress in September-October 2013, but final results have only been reported in print as of late February 2015.
Patients enrolled in the long-term trial previously received pulsed treatment with weight-based infusions of ipilimumab (10 mg/kg) at weeks 1, 4, 7, and 10, followed by treatment with dacarbazine alone at 3-week intervals through week 22 of the initial study.
Following the phase 3 trial, patients were given the opportunity to continue treatment, starting at week 24. In the long-term trial, patients received either placebo or a maintenance infusion of ipilimumab every 12 weeks.
After 5 years, patients receiving ipilimumab were more than twice as likely to be alive than patients receiving placebo. While 8.8% of patients receiving placebo were alive at the 5-year mark, 18.2% of patients receiving active ipilimumab infusions were alive at that time point—a statistically significant difference (P = .002).
Following initial release of these findings, Stephen Hodi, MD of the Dana-Farber Cancer Institute in Boston Massachusetts, stated, "Our data, which represent the longest follow-up of the largest numbers of patients on any globally approved melanoma therapy, will provide a benchmark for future medicines for advanced melanoma.”
Some patients in the analysis had received treatment for more than 5 years, with some having received a decade or more of therapy. Regarding the patients with the longest follow-up, Hodi stated, “Our findings demonstrate that there is a plateau in overall survival, which begins around the third year and extends through to the tenth year.”
With these results, and the results of double and triple therapy trials with other treatments, such as the PD-1/PD-L1 inhibitors, researchers speculated that up to 50% of patients might eventually expect to survive 5 to 10 years after a diagnosis of advanced melanoma. This could ultimately turn the disease into a condition that has less resemblance to cancer and more resemblance to a chronic disease state.
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