UPDATE 2-Celgene cancer drug may be less harmful to heart
* Celgene provides data on Amrubicin drug heart risk
* Says drug has improved profile vs traditional drugs
* Shares down 2.2 pct
BOSTON, Aug 5 (Reuters) - Celgene Corp (CELG.O) said on Wednesday that pooled results from company-sponsored studies of its Amrubicin drug in relapsed small cell lung cancer showed it might be less toxic to the heart than traditional drugs in the same class.
The analysis, which examined data across two mid-stage trials, evaluated 117 patients treated with Amrubicin through an analysis of decreases in left-ventricular ejection fraction, or LVEF. LVEF is a measure of the fraction of blood pumped out of the left ventricle with each heart beat.
Amrubicin is a topoisomerase II inhibitor, a class of drugs that include the anthracycline chemotherapeutic agents. Anthracyclines are known to cause cardiotoxicity that can lead to heart failure in long-term cancer survivors.
"These data suggest that Amrubicin has an improved cardiotoxicity profile compared to traditional anthracyclines," said Dr. Robert Jotte of the Rocky Mountain Cancer Centers.
Amrubicin is a third-generation synthetic anthracycline analogue that is being studied as a single agent and in combination with other therapies for a variety of solid tumors. Until now Celgene has focused on treatments for blood cancers, mainly multiple myeloma.
Results of one 76-patient Phase II trial of patients with small cell lung cancer who responded to first-line platinum-based chemotherapy showed median survival of 9.3 months in the Amrubicin arm, compared with 7.7 months for patients receiving topotecan, a common approved therapy.
The study, presented by Jotte, showed a 44 percent overall response rate -- meaning tumors shrank partially or completely -- in patients taking Amrubicin, compared with a rate of 11.5 percent in patients treated with topotecan. This was a statistically significant difference and met the main goal of the trial.
In A second study, 75 patients who had had no response to first-line chemotherapy, or whose disease had progressed within three months of treatment, were treated until their disease progressed or there was unacceptable toxicity.
The overall response rate in this group was 21.3 percent. Of those who did not respond to platinum-based chemotherapy, the response rate was 16 percent. Median overall survival was 6.1 months.
"The data show that Amrubicin is an active compound with a manageable safety profile in an area of significant unmet need," said Dr. David Ettinger, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, who presented the second study data.
The drug is currently approved and marketed in Japan for the treatment of both small cell lung cancer and non-small cell lung cancer by Nippon Kayaku Co Ltd (4272.T), a Japanese drug company.
Nippon acquired the marketing rights from Dainippon Sumitomo Pharma Co Ltd (4506.T), which originally developed the drug. It licensed the North American and European Union rights of Amrubicin to Pharmion Corp, which Celgene acquired in 2008.
Celgene's shares were down 2.0 percent to $56.62 in afternoon Nasdaq trading. (Reporting by Toni Clarke; Editing by Lisa Von Ahn and Gerald E. McCormick)
