Congress of European Crohn's and Colitis Organisation
Congress of European Crohn's and Colitis Organisation
September 28, 2013
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Ipilimumab extended OS up to 10 years in patients with advanced melanoma

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Patients with advanced melanoma who underwent treatment with the monoclonal antibody ipilimumab survived as long as 10 years, according to results of a pooled analysis presented at the European Cancer Congress.

“A few years ago we could never imagine using the ‘c’ word — a cure for melanoma — and seeing patients live long-term,” F. Stephen Hodi, MD, assistant professor of medicine at Dana-Farber Cancer Institute in Boston, said during a press conference. “What we’re showing here is that there’s been a great paradigm shift. We’re turning this disease in some patients into a chronic illness.”

The primary analysis included 1,861 patients from 12 studies. Of them, two were phase 3 trials (n=790), eight were phase 2 trials (n=821) and two were retrospective, observational studies (n=250).

The majority of patients (67.5%) had undergone prior treatment.

Most patients received ipilimumab (Yervoy, Bristol-Myers Squibb) in the approved dose of 3 mg/kg (n=965) or the investigational dose of 10 mg/kg (n=706) every 3 weeks up to four doses. The majority of studies allowed eligible patients to receive ipilimumab retreatment or maintenance therapy.

Overall, median OS was 11.4 months (95% CI, 10.7-12.1). The 3-year OS rate was 22% overall, 20% among those who had undergone prior treatment and 26% among those with treatment-naive disease.

Researchers observed a plateau in the OS rate after 3 years, and it extended through at least 10 years. Long-term survival was consistent regardless of prior treatment, ipilimumab dose or receipt of maintenance therapy, researchers wrote.

The OS rate at 7 years was 17%, and no deaths occurred among patients who survived longer than 7 years, researchers wrote. The longest OS follow-up in the database is 9 years, Hodi said.

Researchers conducted a secondary analysis of 2,985 patients treated with ipilimumab who were not part of a registered clinical trial. Those patients — which included those with brain metastases and ECOG performance status of 2 — were not included in the primary analysis due to limited survival data.

When those 2,985 patients were added to the analysis, OS among all 4,846 analyzed patients was 9.5 months (95% CI, 9-10). The OS rate was 21% at 3 years, and OS again leveled off at this time point.

“This analysis provides further evidence that supports a durable, long-term survival for patients who received ipilimumab in the advanced melanoma setting,” Hodi said. “This is probably a result of combination of things. It may not be a single mutation, but it may be a combination of the tumor makeup and the patient’s immune system makeup that allow this to happen. Hopefully we will know the answer one day to personalize this medicine in patients.”

For more information:

Schadendorf D. Abstract #E17-7109. Presented at: The European Cancer Congress 2013. Sept. 27 – Oct. 2, 2013; Amsterdam.

Disclosure: The researchers report research funding from, employment and advisory roles with, and stock ownership in Altor, Amgen, Bristol-Myers Squibb, Delcath, Genentech, GlaxoSmithKline, Merck, Novartis, Pfizer, Prometheus and Roche.