Celator Pharmaceuticals Inc., a biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in cancer, announced the publication of Phase 2 data evaluating CPX-351 in adult patients with first-relapse acute myeloid leukemia (AML) in Cancer, a peer-reviewed journal of the American Cancer Society. The study manuscript entitled, “Phase 2, Multicenter, Randomized Trial of CPX-351 (cytarabine:daunorubicin) Liposome Injection Versus Intensive Salvage Therapy in Adults With First Relapse AML,” appears in the January issue.
The published data suggest a clinical benefit from CPX-351 in first relapse AML patients and demonstrate a clear clinical benefit in those with poor-risk disease as defined by the European Prognostic Index (EPI). Along with the previously published results from the Phase 2 study of CPX-351 in newly diagnosed patients with AML, these data support Celator’s Phase 3 study of CPX-351 as a first-line therapy in older patients with high-risk (secondary) AML. Our Phase 3 study, which is being conducted in partnership with The Leukemia & Lymphoma Society recently completed enrollment.
“Patients with first relapse AML have generally a poor prognosis, with a limited likelihood of response following salvage treatment. This is particularly true for patients classified by the EPI as poor-risk upon entering the trial,” said Jorge Cortes, M.D., Lead Investigator and Deputy Chair of the Department of Leukemia at The MD Anderson Cancer Center. “We were very pleased to see promising response rates in this difficult-to-treat population, and we eagerly await results from Celator’s pivotal Phase 3 study of CPX-351, which could fulfill a considerable unmet need in AML.”
The randomized, controlled Phase 2 study enrolled 125 patients, aged 18-65, from 35 centers in the U.S., Canada, and Europe diagnosed with AML in first relapse after an initial complete remission lasting for one month or longer. Patients were randomized 2:1 to receive CPX-351 or investigators’ choice of first salvage chemotherapy. Control salvage treatment was usually based on cytarabine and an anthracycline, often with one or more additional agents. The primary endpoint for the study was survival at one year post treatment.
Patients were stratified per the EPI into favorable, intermediate, and poor-risk groups based on duration of first complete remission, cytogenetics, age, and transplant history, and were well-balanced between the control and the treatment arms. Results showed improved efficacy following CPX-351 and the protocol-defined EPI-poor-risk subset demonstrated statistically significant improvement in overall survival, improvement in event-free survival and higher response rate (39.3 percent vs 27.6 percent). Additionally, 60-day mortality was lower in the CPX-351 study arm for poor-risk patients (16.1 percent vs 24.1 percent).
Treatment with CPX-351 was associated with well-characterized and manageable adverse events. Compared to the control arm, CPX-351 was associated with more frequent hematologic adverse events.
“The insights from this Phase 2 study were very relevant as we designed our Phase 3 pivotal study in older patients with secondary AML, from which initial results, induction response rate, are expected in the second quarter of 2015,” commented Arthur C. Louie, Chief Medical Officer of Celator Pharmaceuticals. “There is a clear need for a therapy with better response rates and lower early mortality than what current first-line and salvage therapies provide, and we hope to be able to offer this with CPX-351.”
Source: Celator Pharmaceuticals
Filed Under: Drug Discovery