CLINICAL STUDIES

Two randomized, double-blind, placebo-controlled trials in adults studied Neumega for the prevention of severe thrombocytopenia following single or repeated sequential cycles of various myelosuppressive chemotherapy regimens.

Study in Patients with Prior Chemotherapy-Induced Thrombocytopenia

One study evaluated the effectiveness of Neumega in eliminating the need for platelet transfusions in patients who had recovered from an episode of severe chemotherapy-induced thrombocytopenia (defined as a platelet count £ 20,000/mL), and were to receive one additional cycle of the same chemotherapy without dose reduction. Patients had various underlying non-myeloid malignancies, and were undergoing dose-intensive chemotherapy with a variety of regimens. Patients were randomized to receive Neumega at a dose of 25 mg/kg or 50 mg/kg, or placebo. The primary endpoint was whether the patient required one or more platelet transfusions i n the subsequent chemotherapy cycle. Ninety-three patients were randomized. Five patients withdrew from the study prior to receiving the study drug. As a result, eighty-eight patients were included in a modified intent-to-treat analysis. The results for the Neumega 50 mg/kg and placebo groups are summarized in Table 1. The placebo group includes one patient who underwent chemotherapy dose reduction and who avoided platelet transfusions.

In the primary efficacy analysis, more patients avoided platelet transfusion in the Neumega 50 mg/kg arm than in the placebo arm (p = 0.04, Fisher's Exact test, 2-tailed). The difference in the proportion of patients avoiding platelet transfusions in the Neumega 50 mg/kg and placebo groups was 21% (95% confidence interval, 2%-40%). The results observed in patients receiving 25 mg/kg of Neumega were intermediate between those of the placebo and the 50 mg/kg groups.

A second study evaluated the effectiveness of Neumega in eliminating platelet transfusions over two dose-intensive chemotherapy cycles in breast cancer patients who had not previously experienced severe chemotherapy-induced thrombocytopenia. All patients received the same chemotherapy regimen (cyclophosphamide 3,200 mg/m² and doxorubicin 75 mg/m²). All patients received concomitant filgrastim (G-CSF) in all cycles. The patients were stratified by whether or not they had received prior chemotherapy, and randomized to receive Neumega 50 mg/kg or placebo. The primary endpoint was whether or not a patient required one or more platelet transfusions in the two study cycles. Seventy-seven patients were randomized. Thirteen patients failed to complete both study cycleseight of these had insufficient data to be evaluated for the primary endpoint. The results of this trial are summarized in Table 2.

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