Data Demonstrated Metastatic Melanoma Response to Investigational,Immunotherapy Ipilimumab ( 20mg/kg single or multiple doses) al...)

Data Demonstrated Metastatic Melanoma Response to Investigational,Immunotherapy Ipilimumab

20 mg/kg, single or multiple doses) alone or in combination with dacarbazine, interleukin-2, or gp100 peptide vaccine. The primary endpoint of this analysis was to examine the kinetics of response to ipilimumab in 356 patients with stage III or stage IV metastatic melanoma; secondary endpoints included duration of objective response (defined as complete or partial response) and stable disease. Analysis of the kinetics of response data demonstrated:

    - Complete or partial response achieved in 13% (46/356) of patients.  Of

      these 46 patients:

      - 61% (28/46) achieved an objective response at week 12 or later

      - 35% (16/46) achieved stable disease prior to objective response

        (complete or partial)

      - 22% (10/46) achieved a partial response, which developed into a

        complete response

    - Current median duration of stable disease (from five of the six studies)

      was more than 15.4 weeks (median duration of objective response has not

      yet been reached).  Twenty-five patients continue to respond with the

      longest response still ongoing at five years.

As previously reported for each individual study, the most common adverse events were immune-related (irAEs) including rash and diarrhea, which were medically manageable and reversible with treatment.

"In some cases, responses were achieved at 12 weeks or later in patients whose disease progressed after treatment with ipilimumab, suggesting that continued treatment through apparent disease progression may be beneficial," said Geoffrey M. Nichol, MBChB, Senior Vice President of Product Development at Medarex. "Further research is needed to fully understand how immunotherapies differ from currently approved chemotherapies."

About Ipilimumab

Ipilimumab is a fully human antibody that binds to CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), a molecule on T-cells that is believed to play a critical role in regulating natural
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