Celator Pharmaceuticals has completed patient enrolment in its Phase III trial of CPX-351 Liposome for Injection versus the existing standard of care, conventional cytarabine and daunorubicin therapy in patients with untreated high-risk (secondary) acute myeloid leukaemia (AML).
A total of 300 patients were enrolled in the trial and they were randomised to receive CPX-351 (100u/m2; Days 1, 3, 5) or conventional 7+3 chemotherapy.
The company said that the trial will remain open for a short time to allow all patients currently in the process of referral and evaluation.
Moffitt Cancer Center senior member and chief of the Leukemia/Myelodysplasia Program Jeffrey Lancet said: "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."
The Phase III trial is being conducted by the company in partnership with the Leukemia & Lymphoma Society (LLS).
The trial enrolled patients aged between 60 and 75 years with newly diagnosed, previously untreated AML arising from prior myelodysplasia or chronic myelomonocytic leukaemia, prior history of chemotherapy or radiotherapy treatment, or with cytogenetic evidence of abnormalities associated with myelodysplasia.
The trial’s primary efficacy endpoint is overall survival, while its 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 results from the final analysis of induction response rate would be reported in the second quarter of 2015, and overall survival data, the primary endpoint of the trial in the first quarter of 2016.
Celator Pharmaceuticals chief executive officer Scott Jackson said: "We are excited to achieve our target enrolment 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.
"Completion of patient accrual in this pivotal Phase III 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."