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Seattle Genetics, Inc. Message Board

  • redhot47fla redhot47fla Dec 7, 2013 10:09 AM Flag

    SGEN releases latest SGN-CD19A trial results

    At the time of data analysis, the maximum tolerated dose had not yet been reached. Enrollment and dose escalation are ongoing.
    Of the 16 adult patients treated across all dose levels, three (19 percent) achieved a complete remission or complete remission with incomplete platelet recovery, eight (50 percent) had resistant disease with clinical benefit or stable disease and five (31 percent) had progressive disease.
    At dose levels greater than 1.0 milligram per kilogram (mg/kg), eight of 10 adult patients had clinical benefit, consisting of complete remission, complete remission with incomplete platelet recovery, resistant disease with clinical benefit or stable disease.
    Of the four pediatric patients, one patient had resistant disease with clinical benefit, one had resistant disease without clinical benefit, one had progressive disease and one was unevaluable.
    The most common adverse events of any grade occurring in adult patients were fever (56 percent), nausea (44 percent), chills (38 percent), fatigue (38 percent), blurred vision (38 percent) and vomiting (38 percent). Adverse events seen in at least two pediatric patients (50 percent or more) were vomiting (three patients) and abdominal pain, cough, shortness of breath, nausea and fever (two patients each).
    “The phase 1 trial evaluating SGN-CD19A has demonstrated encouraging early antitumor activity and a generally well-tolerated safety profile among heavily pretreated patients with acute lymphoblastic leukemia and very aggressive types of lymphoma. In addition, multiple complete remissions have been observed in a parallel phase 1 study evaluating SGN-CD19A in aggressive non-Hodgkin lymphoma. Dose-escalation is ongoing in both phase 1 clinical trials, and we plan to report additional data during 2014,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics.

    Full press release on SGEN's website

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