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Approximately 30,000 patients in the US and 32,000 patients in the EU willbe diagnosed with SCLC this year. "The treatment of small cell lung cancer isextremely challenging, given the limited therapeutic options available," saidMark A. Socinski, Associate Professor of Medicine, Multidisciplinary ThoracicOncology Program, Lineberger Comprehensive Cancer Center, University of NorthCarolina, and a principal investigator in the Phase 3 study. "Preliminarydata suggest that amrubicin could represent a significant improvement in thetreatment of small cell lung cancer, for which there have been no majormedical advances in more than 20 years."
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The study compares amrubicin and topotecan in second-line treatment ofSCLC patients with sensitive or refractory disease. Sensitive disease isdefined as response to first-line platinum-based therapy, with subsequentprogression 90 days or more after completion of therapy. Refractory disease isdefined as no objective response or progressive disease within 90 days ofcompletion of therapy. Study participants are randomized in a 2:1 ratio toreceive either IV amrubicin (40mg/m2 daily for 3 days) or topotecan (1.5 mg/m2daily for 5 days), both starting on Day 1 of a 21-day cycle. The primaryendpoint of this study is overall survival; the secondary endpoints includeprogression-free survival, overall response rate, duration of response andquality of life.
Pharmion has completed the Scientific Advice (SA) process with theEuropean Medicines Agency (EMEA) and has reached Special Protocol Assessment(SPA) agreement with the US Food and Drug Administration (FDA) for theamrubicin Phase 3 SCLC study.
Interim findings from a Phase 2, multi-center clinical study of amrubicinin second-line sensitive SCLC patients provided encouraging initial resultsand informed the design of the pivotal study. These data were presented atthe 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) inJune 2007. Response data from 24 evaluable patients were analyzed, 15 treatedwith amrubicin and nine with topotecan. Of the 15 amrubicin-treated patients,40 percent showed an objective tumor response, including two completeresponses and four partial responses. All responses were confirmed. None ofthe nine topotecan patients showed a response to the drug. The medianduration of progression free survival at the interim analysis was 4.1 monthsfor amrubicin patients compared to 2.0 months for topotecan patients.Patients are being followed for overall survival. The major toxicity ofamrubicin is myelosuppression, which is managed with standard supportivetherapy and dose adjustments.
In addition to the Phase 2 study in second-line sensitive SCLC patients,Pharmion has two additional ongoing Phase 2 studies of amrubicin therapy forsmall cell lung cancer patients; one as single-agent therapy in patientsrefractory to first-line therapy; and one as single-agent or combinationtherapy with cisplatin versus cisplatin plus etoposide in previously untreatedextensive stage patients.
"The Phase 2 studies in small cell lung cancer, in both sensitive andrefractory patients, have thus far generated data fully in line with theresults of the earlier Japanese studies," said Andrew R. Allen, executive vicepresident and chief medical officer of Pharmion Corporation. "We are pleasedto see these exciting data reproduced in patients in the western h
