On June 8, 2015 Celator Pharmaceuticals reported that an investigator-initiated clinical study evaluating CPX-351 (cytarabine:daunorubicin) Liposome Injection in patients with untreated high-risk myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), at high risk of treatment-related mortality has met the efficacy and safety criteria to expand the 32units/m2 dose cohort (Press release, Celator Pharmaceuticals, JUN 8, 2015, View Source [SID:1234505374]). Schedule your 30 min Free 1stOncology Demo! In order to expand the 32units/m2 cohort, the protocol requires 5 or more complete responses and fewer than five deaths by day 28 in the first 20 patients. CPX-351 resulted in 6 responses in the first 20 patients with 2 early treatment-related deaths by day 28. CPX-351 surpassed both criteria and the number of patients in the cohort was increased from 20 to 30.
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Treatment-related mortality (TRM) is a key contributor to overall survival in high risk MDS and AML. This study is evaluating whether CPX-351 is a practical option in patients deemed at high risk of TRM. Patients eligible for this study had TRM scores putting them in the 20 percent of patients at highest risk for early mortality. The rationale for evaluating CPX-351 in these patient populations is based on observations from the earlier conducted and completed Phase 1 and 2 studies with CPX-351, whereby complete responses occurred at dose levels well below the dose being used in the Phase 3 study, with a substantial reduction in early mortality, resulting in an improvement in overall survival in certain patient populations.
Risk assessment for TRM is based on an analysis of 3,365 adults with newly diagnosed AML treated on protocols at Southwest Oncology Group (SWOG) or at MD Anderson Cancer Center. TRM scores provide a means for objectively identifying patients at high-risk for early mortality (treatment-related mortality, or TRM score), such that the higher the TRM score, the greater the risk for treatment-related mortality.
"We are happy to report expansion of this study which seeks an active but safe treatment for patients with AML or MDS at high risk for early treatment-related mortality, who are rarely eligible for conventional chemotherapy," said Roland Walter, MD, PhD, Assistant Member of the Clinical Research Division at the Fred Hutchinson Cancer Research Center, the lead investigator for this study. "The early safety and efficacy observations are encouraging and we look forward to continuing to study CPX-351 in these patient populations."
"As we await the results from the ongoing Phase 3 study in patients with secondary AML, it is important to evaluate the potential benefit of CPX-351 in other patient populations," said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. "Working with investigators at leading cancer centers facilitates the broader evaluation of CPX-351 in patient populations in dire need of therapeutic improvements. We are pleased that CPX-351 was selected as one of these potential therapeutic alternatives and are encouraged to see meaningful therapeutic activity of CPX-351 in these patients."