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Vyxeos™ Improves Survival for Elderly in AML

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Results from a recent phase III clinical trial have demonstrated an improved survival benefit with the use of Vyxeos (CPX-351) compared with the standard chemotherapy combination consisting of cytarabine and daunorubicin (7+3). These results will be submitted for presentation at the upcoming 2016 annual meeting of the American Society of Clinical Oncology (ASCO).

Acute myeloid leukemia (AML) is diagnosed in approximately 20,000 individuals each year in the United States. It is an aggressive leukemia, with the lowest survival rates of any acute leukemias.

AML prevents certain immune cells from developing properly, leaving them in immature stages. These cancerous cells, referred to as “blasts”, are not able to fight infection as intended, and rapidly accumulate in the body. This crowds out other blood cells so that they are not able to carry out their essential functions.

The cornerstone of standard therapy for AML is chemotherapy, and has remained essentially unchanged in the past 25 years, demonstrating a clear need for novel strategies.

One commonly used treatment for the elderly in AML includes the combination of the chemotherapy agents, cytarabine and daunorubicin. This combination is referred to as 7+3 in reference of the ratios of the drugs used together.

However, researchers recently demonstrated that a ratio of 5 to 1, with the same chemotherapy agents, provides improved anti-cancer effects compared to the standard ratio.

Vyxeos is a drug that is in the last phases of clinical trials prior to the submission of approval to the United States Food and Drug Administration (FDA). It is comprised of cytarabine and daunorubicin in the 5 to 1 ratio.

A phase III clinical trial was recently conducted to directly compare Vyxeos to the standard 7+3 combination of cytarabine plus daunorubicin for elderly patients with AML who were at a high risk of developing a disease recurrence. In the trial, one group of patients was treated with Vyxeos, and a second group was treated with the standard 7+3 combination. Results were directly compared between the two groups of patients.

• Median overall survival was improved by 3.6 months for patients treated with Vyxeos (nearly 10 months), compared to those treated with 7+3 (nearly 6 months).

• 12 months following initiation of treatment, 41.5% of patients treated with Vyxeos were still alive, compared with only 27.6% of patients treated with 7+3.

• 24 months following initiation of treatment, 31.1% of patients treated with Vyxeos were still alive, compared with only 12.3% treated with 7+3.

• The rate of serious side effects was comparable between the two treatment groups.

Based on these results, a new drug application (NDA) is expected to be submitted to the FDA later this year.

According to a press release announcing these results, Jeffrey E. Lancet, M.D., senior member and chief of the Leukemia/Myelodysplasia Program at Moffitt Cancer Center and the principal investigator for the study stated that "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 "This represents a major step forward for a very difficult-to-treat patient population."

Reference: Celator Pharmaceuticals, Inc. Celator Announces Phase 3 Trial for VYXEOS™ (CPX-351) in Patients with High-Risk Acute Myeloid Leukemia Demonstrates Statistically Significant Improvement in Overall Survival. Available at: http://ir.celatorpharma.com/releasedetail.cfm?ReleaseID=960543. Accessed March 15, 2016.