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Data Demonstrated Metastatic Melanoma Response to Investigational,Immunotherapy Ipilimumab

imumab. The primary endpoint of the study was to investigate the safety and clinical activity of various doses of ipilimumab. The study enrolled 88 patients with unresectable stage III or stage IV malignant melanoma in three cohorts receiving varying doses and regimens. Analysis of the data demonstrated:

    - Overall disease control - defined as objective responses (complete and

      partial) and stable disease - achieved in 19% (17/88) of patients.

      - In the cohort of 23 patients who were treated at 10 mg/kg, disease

        control was achieved in 39% (9/23), which lasted six months or longer

        in nearly all patients (8/9).

    - Duration of disease stabilization or response exceeded six months in 15%

      (13/88) of patients.  The longest effect observed (stable disease) is

      ongoing for more than a year.

Adverse events reported in this study were consistent with those immune- related adverse events (irAEs) results in other clinical trials of ipilimumab (diarrhea, rash, adrenal insufficiency, elevated liver enzymes). In this study, the overall incidence of irAEs was 72% (63/88). All patients who achieved a response (complete or partial responses) and most patients who achieved stable disease (12/13) also reported an irAE - primarily grade 1 or 2 with the exception of grade 3 diarrhea (1/88), adrenal insufficiency (1/88) and liver abnormalities (1/88) in three patients with stable disease. Twenty- eight percent (25/88) of patients reported serious adverse events (SAEs) regardless of causality, nine of which were ipilimumab-related, but not dose dependent. Most events were reversible without sequelae.

(Abstract #8525) Analysis of data aggregated from six Phase I and II trials, presented by Omid Hamid, MD, an investigator at The Angeles Clinic and Research Institute in Los Angeles, California, showed durable objective responses and stable disease in some patients who received varying doses of ipilimumab (0.1 up to
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