Taiho Pharmaceutical Co., Ltd. (Headquarters: Tokyo, President: Masayuki Kobayashi) announced today that a novel antitumor agent ET-743 (generic name: trabectedin, EU product name: Yondelis®) met its primary endpoint of progression free survival in a Phase 2 clinical trial, conducted in malignant soft tissue sarcoma patients of histological types*1 reported to have chromosomal translocations.
Taiho Pharmaceutical has been conducting the development of ET-743 in Japan based on the Development and Commercialization License Agreement entered March 2009 with PharmaMar SA in Spain.
Detailed trial results will be presented at the 50th American Society of Clinical Oncology® (ASCO®), planned to be held in Chicago USA from May 30th to June 3rd this year.
To make ET-743 available for Japanese patients and health care professionals as a new treatment option against malignant soft tissue sarcoma, an area of high unmet medical needs, Taiho will strive to obtain marketing approval of ET-743 in Japan.
(About Phase 2 clinical trial)
This was a Phase 2 clinical trial in malignant soft tissue sarcoma patients of histological types reported to have chromosomal translocations, comparing progression free survival of ET-743 arm with best supportive care (BSC) arm as the control. 12 medical sites in Japan participated, and 76 patients were enrolled between July 11th, 2012 and January 20th, 2014.
(About malignant soft tissue sarcoma)
Malignant soft tissue sarcoma is an intractable malignancy which develops in the soft tissues (muscles, connective tissues, fat, blood and lymph vessels, etc.) of the body. In Japan, annual incidence rate is 2 to 3 cases per 100,000 population, and it is an orphan disease with an estimated patient number of 3,000*2.
ET-743 is a novel antitumor agent developed by PharmaMar, originally isolated from the Caribbean unicate Ecteinascidia turbinate and now produced synthetically. It binds to the minor groove of DNA, interfering with cell division, genetic transcription processes and the DNA repair machinery, and its antitumor activity affects the tumor microenvironment as well. Under the product name Yondelis®, it was first approved by the European Medicines Agency in September 2007 for the treatment of advanced soft tissue sarcoma, and in September 2009 for use in combination with pegylated liposomal doxorubicin for relapsed platinum-sensitive ovarian cancer patients. Currently, Yondelis® is approved and marketed in 80 countries worldwide, including EU countries, Russia, Korea, Canada, etc.
PharmaMar is a subsidiary of the Zeltia Group (Spanish Stock Exchange symbol: ZEL), and a world leader biopharmaceutical company committed to advancing the treatment of cancer through the discovery and development of new marine-derived medicines. Zeltia Group has been quoted on the Spanish Stock Exchange since 1963, and is based in Madrid, Spain.
*1: Presence of fusion genes and tumor specific chromosomal translocations have been reported in some malignant soft tissue sarcomas. Chromosomal translocation is when chromosomes break and the fragments fuse to other chromosomes. It is thought that the fusion genes occurring from this chromosomal translocation might be the cause of malignancies.
*2: Calculated by subtracting 2,000 “mesothelioma” patients from the 5,000 “malignance of mesothelioma and soft tissue” patients, referencing the MHLW Patient Survey (2008).