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news.Genta Incorporated has reported that new Phase III trial data of Genasense injection for relapsed or refractory chronic lymphocytic leukemia showed that patients who achieved complete remission, the primary endpoint of the trial, with Genasense plus chemotherapy, have shown extended survival compared with patients whose complete remission was induced with chemotherapy alone.
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The new data showed that the median survival of patients treated with Genasense plus chemotherapy who achieved complete remission (CR, defined as complete plus nodular partial response) has still not been reached but currently exceeds 55+ months, compared to a median of 45 months in the chemotherapy-alone group. Of 20 patients in the Genasense group who achieved CR, 12 (60%) remain alive compared with three of the eight patients who achieved CR with chemotherapy alone (38%).
With a minimum follow-up of 54 months, nine of the 12 CR patients in the Genasense group have not required additional therapy, and five (25%) remain in continuous CR. In the chemotherapy-alone group, all three survivors who previously achieved CR have relapsed, and all have required additional anti-leukemic therapy.