Celator Pharmaceuticals Announces Data on the Effects of CPX-351 in High Risk AML Presented at the ASH Annual Meeting
-- Relative benefit of CPX-351 in previously untreated AML is greatest in patients with multiple risk factors --
PRINCETON, N.J.--(BUSINESS WIRE)--Dec 11, 2012 - Celator Pharmaceuticals today announced new data on previously untreated elderly patients with acute myeloid leukemia (AML) and multiple-risk factors treated with CPX-351 (cytarabine:daunorubicin) Liposome Injection. An analysis of results from a randomized Phase 2b clinical study showed that CPX-351, already reported to be highly active in all patient subgroups, produced the greatest benefits in response rate and reduction in 60-day mortality compared to standard therapy in patients with secondary AML and adverse cytogenetics. The findings were presented at the 54th American Society of Hematology (ASH) Annual Meeting being held in Atlanta, Georgia (ASH Abstract #3626).
The open-label Phase 2b study compared CPX-351 to the current standard of care, conventional cytarabine and daunorubicin (7+3 regimen). Patients between the ages of 60-75 years with previously untreated AML (including secondary AML) were enrolled at 18 sites in the United States and Canada and stratified as high risk (age ‰¥70 or secondary AML or ‰¥3 chromosomal abnormalities) or standard risk (all other patients). The primary endpoint was complete response (CR) plus CRi (complete response with incomplete recovery of neutrophils or platelets) rate.
Investigators assessed the association between baseline characteristics and survival using univariate and multivariate Cox regression analyses. The univariate model demonstrated that response, two or more risk factors, secondary AML, and adverse cytogenetics all had a significant effect on overall survival. In the multivariate analysis, both response (p=0.008) and two or more risk factors (p=0.013) were most strongly associated with overall survival. Patients with 2 or 3 risk factors treated with CPX-351 had rates of response and 60-day mortality that were similar to those with only 0 or 1 risk factors. However, patients with multiple risk factors treated with 7+3 did much worse, with fewer CRs, no CRi's, and a substantially higher rate of early death.
"This analysis suggests that CPX-351 may provide the greatest improvement in outcomes for patients with AML whose expected prognosis following standard therapy would have been the poorest," said Jeffrey E. Lancet, M.D., of the H. Lee Moffitt Cancer Center in Tampa, FL, and the principal investigator for the study.
"We hope to confirm this promising finding in our Phase 3 program for CPX-351, which focuses on a high risk patient population and is currently getting underway," added Scott Jackson, chief executive officer of Celator Pharmaceuticals.
In the study, adverse events associated with CPX-351 treatment were well-characterized and manageable. The myelosuppressive effect of CPX-351 was greater than 7+3 with neutrophil and platelet recovery approximately one week longer, and adverse events were consistent with these effects.
Clinical Findings for Patients with 2 or 3 Risk Factors
|CPX-351 (n= 26)||7+3 (n= 15)|
|CR Rate (%)||11 (42.3)||4 (26.7)|
|CRi Rate (%)||7 (26.9)||0|
|CR+CRi Rate (%)||18 (69.2)||4 (26.7)|
|60-Day Mortality Rate (%)||1 (3.8)||6 (40.0)|
|Median Event Free Survival||9.1 months||1.1 months|
|Median Overall Survival||10.7 months||6.1 months|
CPX-351 (cytarabine:daunorubicin) Liposome Injection represents a new approach to developing combinations of drugs in which drug molar ratios with synergistic anti-tumor activity are encapsulated in a drug delivery vehicle in order to maintain the desired ratio following administration. CPX-351 has been granted orphan drug status by both the U.S. and the European Union. CPX-351 has completed two randomized, controlled, phase 2 clinical studies for the treatment of acute myeloid leukemia (AML). One study compared CPX-351 to the standard ˜7+3” regimen of cytarabine:daunorubicin in patients 60-75 years of age with newly diagnosed AML and the other compared CPX-351 versus intensive salvage therapy in first relapse AML patients 18-65 years of age. The study in patients with first relapse AML was supported by The Leukemia & Lymphoma Society®, which is also collaborating in the planned Phase 3 study of CPX-351 versus 7+3 in elderly patients with high risk (secondary) AML.
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Princeton, NJ, and Vancouver, BC, is a privately held pharmaceutical company developing new and more effective therapies to treat cancer. CombiPlex®, the company's proprietary drug ratio technology platform, represents a novel approach that identifies molar ratios of drugs that will deliver a synergistic benefit, and locks the desired ratio in a nano-scale drug delivery vehicle that maintains the ratio in patients with the goal of improving clinical outcomes. The company pipeline includes two clinical stage products; CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia and CPX-1 (a liposomal formulation of irinotecan:floxuridine) for the treatment of colorectal cancer; a preclinical stage product, CPX-571 (a liposomal formulation of irinotecan:cisplatin); and multiple research programs, including the hydrophobic docetaxel prodrug nanoparticle (HDPN) formulation being studied by the National Cancer Institute's Nanotechnology Characterization Laboratory. Based on the applications of CombiPlex and the proprietary nanoparticle prodrug delivery platform, Celator is positioned to advance a broad pipeline of cancer therapies involving both previously approved and novel drug agents. For more information, please visit the company's website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.
Sam Brown, Inc.
Mike Beyer, 773-463-4211
Posted: December 2012