Eisai Provides Preliminary Efficacy Update On EORTC Phase III Trial of Dacogen(R) Versus Supportive Care in Patients With Myelodysplastic...(riteria) was achieved with theoutpatient...),Health

Eisai is committed to a clinical development program to optimize the utility of Dacogen for all patients with MDS. Recent studies of hypomethylating agents have suggested that treatment of patients should continue for as long as they receive clinical benefit or until their disease progresses. To advance the understanding of optimal treatment for MDS and related conditions, there are currently more than 30 ongoing trials with Dacogen either as a single agent or in combination with other therapies, including a Phase III survival study in older patients with acute myelogenous leukemia (AML).

Study Design

EORTC-06011: This Phase III open-label, randomized, multi-center, controlled trial evaluated overall survival of patients receiving Dacogen plus BSC versus BSC only. The study involved 233 elderly patients, greater than or equal to 60 years of age, with predominantly high-risk or Intermediate-2 type MDS.

Patients included in the trial had primary or secondary MDS with or without previous therapy with growth factors, immunosuppressive agents or hydroxyurea. In order to participate in the study, patients had to have bone marrow blast counts between 11 and 30 percent. Patients with blast counts below 10 percent were required to have had poor-risk cytogenetics in order to be eligible for randomization.

DACO-020: This is a multi-center, open-label, single arm Phase II study of Dacogen in 99 patients with de novo or secondary MDS. Dacogen was administered daily for five days repeated every four weeks. Patients were greater than or equal to 18 years of age with MDS (de novo or secondary) of any FAB subtype and with an International Prognostic Scoring System score of greater than or equal to 0.5. In order to
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