CHICAGO, Pharmion Corporation today released interim findings from its Phase II, multi-center clinical study of Amrubicin, the company's third-generation synthetic anthracycline currently in development for the treatment of small cell lung cancer.
These findings indicate favorable interim results in terms of response rate and safety when comparing Amrubicin to the current treatment standard, topotecan, in second-line treatment of platinum-sensitive small-cell lung cancer patients with extensive disease (ED-SCLC). The early results of this study were published online on the ASCO website during the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Ill.
"Oncologists have very limited treatment options available for patients with extensive-disease small cell lung cancer, and regrettably, patients with this disease still have an exceptionally poor prognosis," said Andrew R. Allen, chief medical officer of Pharmion. "We are encouraged by these initial results which suggest Amrubicin's potential to improve the treatment landscape for small cell lung cancer."
The trial compares Amrubicin and topotecan in patients with ED-SCLC that initially responded to first-line platinum-based therapy but recurred or progressed at least 90 days after completion of first-line treatment. Study participants are randomized 2:1 to receive either Amrubicin (40 mg/m2 via 5- min.infusion daily x 3 days) or topotecan (1.5 mg/m2 via 30-min. infusion daily x 5 days), both starting on Day 1 of a 21-day cycle.
Response data from 24 evaluable patients have been analyzed, 15 treated with Amrubicin and nine with topotecan. Of the 15 Amrubicin patients, 40 percent showed an objective tumor response, including two complete responses and four partial responses. All responses are confirmed. None of the nine topotecan patients showed a response to the drug. The median duration of progression free survival at the interim
analysis was 4.1 months for Amrubicin patients compared to 2.0 months for topotecan patients. Patients are being followed for overall survival.
Thirty patients in the trial were evaluable for toxicity and safety, 19 for Amrubicin and 11 for topotecan. The most common . grade 3 adverse events were hematological and were generally equal between the two arms. Cardiac adverse events were limited to tachycardia (< grade 3) for one Amrubicin and two topotecan patients. No anthracycline-induced cardiomyopathy has been observed to date.
"These results are extremely encouraging and entirely consistent with the data reported from Japanese studies," said Mark A. Socinski, Associate Professor of Medicine, Multidisciplinary Thoracic Oncology Program, Lineberger Comprehensive Cancer Center, University of North Carolina, and a principal investigator in the Phase 3 study which will begin shortly for Amrubicin in second-line treatment of small cell lung cancer. "With no apparent difference in activity between Japanese and non-Japanese patients, Amrubicin may represent an important new treatment for this very difficult to treat disease."
Pharmion has two additional ongoing Phase 2 studies of Amrubicin therapy for small cell lung cancer patients; one as single-agent therapy in patients refractory to first-line therapy; and one as single-agent or combination therapy with cisplatin versus cisplatin plus etoposide in previously untreated extensive stage patients. Related medicine news :1
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