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Celator Pharmaceuticals Presented Phase 3 Trial Results in Patients with High-Risk Acute Myeloid Leukemia Demonstrating VYXEOS (CPX-351) Significantly Improved Overall Survival
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VYXEOS also demonstrated a statistically significant improvement in induction response rate (CR+CRi of 47.7% versus 33.3%; p=0.016) and this significance was maintained for the analysis of CR alone (CR of 37.3% versus 25.6%, p=0.040). Thirty-four percent of VYXEOS treated patients received a stem cell transplant (SCT) compared to 25% of 7+3 treated patients. In a landmark survival analysis of patients receiving a SCT, VYXEOS patients had significantly improved survival post-transplant (HR was 0.46 (p-value=0.0046)). The median overall survival had not been reached in the VYXEOS treated patients compared to 10.25 months in the 7+3 treated patients.Thirty-day and sixty-day all-cause mortality favored VYXEOS. Thirty-day mortality was 5.9% compared to 10.6% and sixty-day mortality was 13.7% versus 21.2%.Grade 3-5 non-hematologic and hematologic adverse events were similar between the VYXEOS and 7+3 arms.
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Jun 06, 2016
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Related Keywords Vyxeos, Cpx-351, Acute Myeloid Leukemia, Phase 3, Liposome, Cytarabine, Daunorubicin, Asco 2016