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Updated Phase II data show ipilimumab-treated patients with metastatic melanoma still alive after one year of therapy

Monday, October 06 2008 | Comments

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What's This? Ipilimumab may increase the number of treatment-experienced patients with advanced metastatic melanoma who survive beyond 1 year, according to data from 3 Phase II studies that were presented in Stockholm, Sweden, at the 33rd Congress of the European Society for Medical Oncology.

The studies included a total of 487 patients with stage III or stage IV metastatic melanoma who received ipilimumab 0.3 mg/kg of body weight, ipilimumab 3 mg/kg, or ipilimumab 10 mg/kg. One-year survival rates in this population of patients are typically approximately 25%, according to Bristol-Myers Squibb Co. and Medarex Inc., the drug's development partners. Approximately half of the patients in each of the trials had organ involvement.

The first trial, known as 008, was an open-label, single-arm trial designed to evaluate overall response to ipilimumab therapy in 155 patients who experienced progression during or after standard therapies. In this trial, the 1-year survival rate for those who received 10 mg/kg of ipilimumab was 47%, with a follow-up period of 24.8 months.

As previously reported, the 008 trial was conducted under a special protocol assessment and failed to reach its primary endpoint of ruling out a best objective response rate of less than 10%.

The next trial, known as 022, was a randomized, double-blind trial that evaluated the efficacy of ipilimumab in 217 patients who were previously treated, relapsed, or had inadequate response to experimental therapy or were intolerant to approved therapies. In this trial, the 1-year survival rate was 48% for the patients who received ipilimumab 10 mg/kg, with a follow-up period of 21.9 months.

The third trial, known as 007, was a randomized, double-blind trial that evaluated the rate of grade II diarrhea in 115 patients who received ipilimumab with or without the prophylactic use of budesonide. In this trial, the 1-year survival rate for those who received 10 mg/kg of ipilimumab was 51%, with a follow-up period of 26.3 months, despite the fact that 10% of the patients in the trial had brain metastases at baseline.

Safety results from the studies were generally consistent with data from previously reported trials of ipilimumab, and the most common immune-related adverse events were rash, diarrhea and hepatitis.

BMS and Medarex intend to present efficacy and survival data from trial 024, an ongoing Phase III, randomized, double-blind study comparing ipilimumab 10 mg/kg in combination with dacarbazine versus dacarbazine alone in patients with untreated, unresectable stage III or stage IV metastatic melanoma, and from trial 029, an ongoing Phase III study of ipilimumab administered as adjuvant therapy in patients with high-risk stage III metastatic melanoma.

This information concerns a use that has not been approved by the Food and Drug Administration.

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