NCI ANNOUNCES RESULTS FROM TRIAL USING CEPHALON'S TRISENOX

The NIH's National Cancer Institute (NCI) has announced positive results from a Phase III clinical trial of an uncommon form of leukemia. The results showed that adult patients with previously untreated acute promyelocytic leukemia (APL) who had standard chemotherapy to induce remission of their disease, and then received Cephalon's Trisenox (arsenic trioxide) chemotherapy to maintain remission, had a significantly better event-free survival and better overall survival than those who received only standard chemotherapy.

APL accounts for approximately 10 percent of acute myeloid leukemia cases, according to the NCI. This type of leukemia is often accompanied by life-threatening bleeding at diagnosis that typically worsens, even as initial treatment is administered.

The study tested the effectiveness and side effects of adding two 25-day courses of intravenous arsenic trioxide to the combination of all-trans retinoic acid (ATRA) and chemotherapy. Patients with newly diagnosed APL were randomly assigned to receive: the standard remission treatment with ATRA twice daily, daunorubicin for four days and cytarabine for seven days, both of which are standard chemotherapy drugs for this disease, followed by a standard post-remission regimen with two more courses of ATRA plus daunorubicin; or the experimental treatment where patients received the same standard treatment with the addition of two courses of Trisenox given immediately after the patient entered a complete or partial remission and before the standard post-remission regimen.

The percentage of adult patients who remained alive and in remission three years after diagnosis was 77 percent in the Trisenox treatment arm compared with 59 percent in the standard treatment arm.

Trisenox is currently indicated for the induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the translocation of PML/RAR-alpha gene expression. While Cephalon is evaluating the new study results as well as other areas of interest to consider future development of Trisenox, the product is not currently approved for any use beyond its labeled indications.