publication date: Mar. 31, 2016


Vyxeos Injection Improves Overall Survival in Phase III Acute Myeloid Leukemia Trial 


A phase III trial of Vyxeos Liposome for Injection demonstrated statistically significant improvements in overall survival in patients with high-risk secondary acute myeloid leukemia.

The median overall survival for patients treated with Vyxeos (cytarabine: daunorubicin) in the study was 9.56 months compared to 5.95 months for patients receiving the standard of care regimen of cytarabine and daunorubicin known as 7+3.

The hazard ratio was 0.69 (p=0.005) which represents a 31 percent reduction in the risk of death versus 7+3, according to Celator Pharmaceuticals Inc., the drug’s sponsor, which plans to submit the data for presentation at the 2016 annual meeting of the American Society of Clinical Oncology.

The rates of overall survival at 12 months were 41.5 percent in the Vyxeos arm compared to 27.6 percent in the 7+3 arm. At 24 months, the rates were 31.1 percent in the Vyxeos arm, and 12.3 percent in the 7+3 arm.

“The overall survival advantage seen with CPX-351 compared to 7+3, along with a superior response rate and no increase in serious toxicity indicates that we’ll likely have a new standard of care for treating older patients with secondary AML,” said Jeffrey Lancet, senior member and chief of the Leukemia/Myelodysplasia Program at Moffitt Cancer Center and the principal investigator for the study. “This represents a major step forward for a very difficult-to-treat patient population.”

Vyxeos also demonstrated a statistically significant improvement in induction response rate … Continue reading CCL March – Vyxeos Injection Improves Overall Survival in Phase III Acute Myeloid Leukemia Trial

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