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Pharmion's Amrubicin Shows Encouraging Results Compared to Standard of Care in Second Line Treatment of Small Cell Lung Cancer
Date:11/9/2007

m2 daily for 3 days) or topotecan (1.5 mg/m2 daily for 5 days), both starting on Day 1 of a 21-day cycle.

Response data from 42 patients have been analyzed, 28 treated with Amrubicin and 14 with topotecan. Eleven of 28 (39 percent) patients who received one or more cycles of Amrubicin have demonstrated a response, including two complete responses (CR) and nine partial responses (PR). Eight of the responses are confirmed and three are pending follow-up scans. Two of 14 (14 percent) patients who received one or more cycles of topotecan had a response (both PRs). One is confirmed and one is pending a follow-up scan.

Survival times are not yet mature, however, at this time preliminary data already show an observed difference of 2.4 months in overall survival, which translates to a hazard ratio of 0.67, favoring Amrubicin.

The most common adverse events were hematological and were generally equal between the two arms. No classical anthracycline cardiotoxicity has been observed to date, supporting data from earlier Japanese studies that suggest Amrubicin may be devoid of this anthracycline-associated adverse event.

A second Amrubicin Phase 2 trial is also underway evaluating single-agent Amrubicin in patients with ED SCLC that are chemo-refractory or progressive within 90 days of completion of first-line platinum-based chemotherapy (refractory SCLC). Study participants receive Amrubicin (40 mg/m2 via 5-minute infusion daily for 3 days) on Day 1 of a 21-day cycle.

Enrollment in both second-line Phase 2 studies of Amrubicin is expected to complete by the end of 2007.

Pharmion has an additional ongoing Phase 2 study of Amrubicin in first line SCLC patients in association with the European Organization for the Research and Treatment of Cancer (EORTC). This study evaluates Amrubicin as single-agent or combination therapy with cisplatin versus cisplatin plus etoposide in previously untreated ED-SCLC patients. Preliminary data from this study
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SOURCE Pharmion Corporation
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