Celgene International Sàrl (Nasdaq: CELG) today announced physicians from leading international medical centers presented data from a Phase II clinical study of Amrubicin in patients with extensive–disease small–cell lung cancer (SCLC) sensitive to platinum–based first–line therapy. Preliminary results of the study demonstrated an improved overall response rate that compare favorably with topotecan, as well as no evidence of cardiotoxicity with cumulative dosing in excess of 2,000 mg of Amrubicin. The data were presented at the 33rd European Society for Medical Oncology Congress in Stockholm, Sweden.
In this randomized, multi–center U.S. study involving 48 centers, patients with SCLC and sensitive to previous first–line platinum–based chemotherapy received either intravenous (IV) Amrubicin 40 mg/m2/day on days 1 to 3 of a 21–day cycle or IV topotecan 1.5 mg/m2/day on days 1 to 5 of a 21–day cycle. The primary endpoint was response rate, and secondary endpoints were time to disease progression, progression–free survival, overall survival and safety.
The primary endpoint of the study was met, with patients receiving Amrubicin demonstrating an overall response rate of 36 percent, compared to 8 percent of patients receiving topotecan (p=0.012). Additionally, the median progression–free survival time for Amrubicin patients is 130 days compared to 100 days for topotecan. Amrubicin was well tolerated in patients with advanced SCLC, with myelosuppression as the main dose–limiting toxicity.
"The impressive response rate seen in this study of Amrubicin demonstrates a favorable comparison to results in patients treated with topotecan and warrant further study of this promising new anthracycline," said Dr. Robert M. Jotte of the Rocky Mountain Cancer Centers in Denver, Co. and the lead investigator of the study. "The continuing flow of information from clinical studies of Amrubicin is leading the way to new options for patients with this critical disease."
These results build upon the increasing body of research and create a foundation for ongoing Phase III clinical studies of Amrubicin in small cell lung cancer.
About Amrubicin
Amrubicin is a third–generation, synthetic anthracycline analogue that has demonstrated substantial clinical efficacy in the treatment of small cell lung cancer. Amrubicin is a potent topoisomerase II inhibitor and is being studied as a single agent and in combination with anti–cancer therapies for a variety of solid tumors, including lung cancer.
Amrubicin is currently approved and marketed in Japan for the treatment of lung cancer by Nippon Kayaku, a Japanese pharmaceutical firm focused on oncology, which licensed Japanese marketing rights from Dainippon Sumitomo Pharma, the original developer of the therapy. Dainippon Sumitomo Pharma also licensed the North American and European Union rights of Amrubicin to Pharmion Corporation, which was acquired by Celgene Corporation in March 2008. Amrubicin has been granted orphan–drug designation for the treatment of small cell lung cancer in both the U.S. and European Union, and Fast Track product designation by the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer after first–line chemotherapy.
About Small Cell Lung Cancer
Small cell lung cancer is a disease in which malignant cells form in the tissues of the lung, and which occurs almost exclusively in people who smoke. While small cell lung cancer constitutes approximately 15 percent of all lung cancers, SCLC tends to be more aggressive and fast growing than the more common non–small cell lung cancer. An estimated 65,000 patients are diagnosed with SCLC each year in the US and EU.
About Celgene International Sàrl
Celgene International Sàrl, located in Boudry, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company´s website at www.celgene.com.
This release contains certain forward–looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company´s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward–looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company´s filings with the Securities and Exchange Commission such as Form 10–K, 10–Q and 8–K reports.
