On October 27, 2014 Celator Pharmaceuticals reported that the target enrollment of 300 patients has been achieved in the company’s multicenter, randomized, open-label Phase 3 study of CPX-351 (cytarabine:daunorubicin) Liposome for Injection versus the current standard of care, conventional cytarabine and daunorubicin therapy (7+3) in patients with untreated high-risk (secondary) acute myeloid leukemia (AML) (Press release Celator Pharmaceuticals, OCT 27, 2014, View Source [SID:1234500882]). The study randomized the 300th patient ahead of schedule and will remain open for a short time to enable all patients currently in the process of referral and evaluation to complete enrollment into the study.
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"AML continues to be a devastating condition with a particularly poor prognosis in the high-risk population. Unlike other cancers, treatments for AML have not significantly advanced patient outcomes for several decades. Based on results to date and the combination-optimizing mechanism behind CPX-351, I am hopeful that we can soon offer a superior option to standard chemotherapy in older patients with high-risk AML," commented Jeffrey Lancet, M.D., Senior Member and Chief of the Leukemia/Myelodysplasia Program at Moffitt Cancer Center.
Celator is conducting the pivotal Phase 3 study in partnership with The Leukemia & Lymphoma Society (LLS). The study enrolled patients between the ages of 60 and 75 with newly diagnosed, previously untreated AML arising from prior myelodysplasia or chronic myelomonocytic leukemia, prior history of chemotherapy or radiotherapy treatment, or with cytogenetic evidence of abnormalities associated with myelodysplasia. Patients were randomized to receive CPX-351 (100u/m2; Days 1, 3, 5) or conventional 7+3 chemotherapy. The primary efficacy endpoint of the study is overall survival. Secondary endpoints include complete response (CR+CRi) rate, duration of remission, 30- and 60-day mortality, event-free survival, aplasia rate, and rate of stem cell transplant. The study began enrollment in December 2012 and is being conducted at leading institutions in the U.S. and Canada. Results from the final analysis of induction response rate are expected in the second quarter of 2015, and overall survival data, the primary endpoint of the study, are expected in the first quarter of 2016.
"We are excited to achieve our target enrollment ahead of schedule and believe it demonstrates both the great need for a new treatment for AML patients, as well as strong clinical interest in CPX-351," said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. "Completion of patient accrual in this pivotal Phase 3 study is an important milestone for Celator. We look forward to reporting the induction response rate results in the second quarter of 2015 and we project the primary endpoint data of overall survival to be available in the first quarter of 2016. In addition, we are especially grateful to the patients, the clinical investigators, and our partner, the LLS, for participating in this study."