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news.Eisai Corporation of North America has announced positive data from a Phase II trial evaluating a five-day dosing regimen of Dacogen in acute myeloid leukemia.
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The study involved elderly patients with acute myeloid leukemia (AML), who often have limited options due to comorbidities and are typically considered ineligible for standard induction chemotherapy.
Data from the Phase II study reported a complete response rate of 24%. A complete response designation requires that the patient have less than 5% blasts in the marrow, no evidence of disease outside of the bone marrow and absolute neutrophil and platelet counts of more than 1,000/ul and 100,000/ul, respectively. The majority of patients in the trial had intermediate or poor risk cytogenetics, which are associated with poor prognoses.
Responses were observed across all patients including those with poor risk cytogenetics, those whose AML transformed from MDS, or those who developed AML after previous treatment for cancer. The results provide additional support for the ongoing investigation of Dacogen in a Phase III trial currently underway in elderly patients with AML, the company said.
According to the AML response criteria, the expert-reviewed overall response rate in the intent-to-treat population was 26%, with morphologic CR in 24% of patients and CR with incomplete blood count recovery in 2%. The median time to response was three months, and responses were seen in all subgroups of patients, including patients with the poorest prognoses.
Additionally, 44% of patients maintained stable disease during a median five cycles of therapy. The five-day dosing regimen of Dacogen is currently being further evaluated in a global, Phase III survival study in elderly patients with AML.
Edward Rubenstein, senior vice president of medical affairs for oncology and institutional care business unit at Eisai, said: We are enthusiastic about these new data and look forward to seeing results from our ongoing, global Phase III trial evaluating Dacogen in elderly AML patients. The data support our commitment to continue to evaluate Dacogen as a treatment option for elderly patients with AML.