JCO publishes pivotal Phase 3 data for Jazz Pharmaceuticals' Vyxeos
Jazz Pharmaceuticals announced that data from the pivotal Phase 3 study of Vyxeos (daunorubicin and cytarabine) liposome for injection compared to standard of care cytarabine and daunorubicin (7+3) were published online in the Journal of Clinical Oncology. The study evaluated the efficacy and safety of Vyxeos compared to 7+3 in 309 patients who were between 60 to 75 years of age with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes, a rapidly progressing and life-threatening blood cancer. The study met its primary endpoint as Vyxeos demonstrated a superior improvement in overall survival compared to the 7+3 treatment regimen. The median overall survival for the Vyxeos treatment group was 9.6 months compared with 5.9 months for the 7+3 treatment group (2-sided p value = 0.005; HR [95% confidence interval] = 0.69 [0.52, 0.90]). Vyxeos was also associated with a significantly higher remission rate than 7+3 with a complete response rate of 38% versus 26%; p=0.036. In addition, the overall rate of hematopoietic stem cell transplant was 34% in the Vyxeos arm and 25% in the 7+3 arm. The reported adverse reactions with Vyxeos were generally consistent with the known safety profile of cytarabine and daunorubicin therapy. Vyxeos was approved by the U.S. Food and Drug Administration in August 2017, and is the first FDA-approved treatment specifically indicated for adults with newly-diagnosed t-AML or AML-MRC. Data from the study formed the basis of the FDA application and the Marketing Authorization Application (MAA) to the European Medicines Agency's Committee for Medicinal Products for Human Use.