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ARTICLE | Clinical News

Calsed amrubicin: Phase III data

May 23, 2011 7:00 AM UTC

The open-label, international Phase III ACT-1 trial in 637 patients showed that IV amrubicin as second-line therapy missed the primary endpoint of significantly improving OS vs. topotecan (7.5 vs. 7.8 months, p=0.17). Amrubicin also missed the secondary endpoint of significantly improving PFS vs. topotecan (4.1 vs. 4 months, p=0.98), but met the secondary endpoint of significantly improving ORR (31% vs. 17%, p=0.0002). In patients with refractory (n=295) or sensitive SCLC (n=342), OS was 6.2 and 9.2 months, respectively, vs. 5.7 and 10 months for topotecan (p=0.047 and p=0.62). Celgene said that small numerical differences in patient characteristics in favor of the topotecan group may have impacted OS. The most common grade 3/4 adverse events were neutropenia, thrombocytopenia, anemia, infections, febrile neutropenia and cardiac disorders. Patients received daily 40 mg/m 2 amrubicin for 3 days of a 21-day cycle or daily 1.5 mg/m 2 topotecan for 5 days of a 21-day cycle. Data will be presented at the American Society of Clinical Oncology meeting in Chicago in June. ...