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news.Simcere Pharmaceutical, a manufacturer and supplier of branded generic pharmaceuticals, has completed Endostar Phase IV clinical study.
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Simcere Pharma said that Endostar is approved as a Class-1 drug by the State Food and Drug Administration (SFDA) for the treatment of cancer (license no S20050074). Since September 2005, the Chinese government has licensed Endostar to treat non-small-cell lung cancer (NSCLC).
The company said that the study was designed as an open label, prospective, and multi-center study and was the first Phase IV clinical study for a Class-1 new drug in China.
In the trial of 2725 subjects, the survival analysis for stage statistics showed that mean survival time (MST) was 17.57 months, 1-year survival rate was 63.68%, 2-year survival rate was 39.79%, and median time to tumor progression (TTP) was 7.37 months. Objective response rate (ORR) was 23.93%, and Disease Control Rate (DCR) was 76.07%.
Endostar Phase IV clinical study verified that Endostar Phase III and IV are comparable and by combining Endostar with standard chemotherapy regimens, this could improve the median survival time and overall survival rate of patients with advanced NSCLC with no significant increase of the adverse effects of chemotherapy.
At the conference, some investigators (such as medical centers in Sichuan and Zhejiang) reported that Endostar was found also significantly effective for the treatment of pleural/ascetic fluid and Gliomas. Currently, there are many on-going clinical studies of Endostar including lung cancer and non-lung cancer (e.g.: Osteosarcoma and Colorectal cancer).
With the successful completion of Endostar’s Phase IV clinical study, as required by the new national drug registration law, Endostar is expected to be the first new drug to successfully pass re-registration.
Sun Yan, member of the Chinese Academy of Engineering, said: “This Phase IV clinical study is the first of its kind to be completed in China and houses a huge amount of data which we can tap into to help patients suffering from advanced stages of Non-Small-Cell Lung Cancer. These are very encouraging results and with its re-registration, Endostar will bring relief to patients across China for many years to come.”