From rxpgnews.com
Trabectedin for the Treatment of Relapsed Ovarian Cancer Starts Phase III Trial
By PharmaMar,
Apr 4, 2005 - 4:32:38 PM
PharmaMar today announced that, in collaboration with its partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), a pivotal, international, multicentre Phase III clinical trial in ovarian cancer patients has been initiated with YONDELIS(R) (trabectedin).
This Phase III study compares monotherapy liposomal doxorubicin, a Johnson & Johnson product(x) known as CAELYX(R) in Europe, and DOXIL(R) (doxorubicin HCI liposome injection) in the US, to a combination of YONDELIS and CAELYX (DOXIL) in ovarian cancer patients who have relapsed after receiving standard first-line chemotherapy. This randomised study will enrol 650 patients in 110 hospitals across 16 countries (including the US, Europe, Asia and South America).
The primary objective is to test the hypothesis that combination therapy with YONDELIS and DOXIL/CAELYX improves progression-free and overall survival in women with relapsed ovarian cancer . There also will be complementary pharmacogenomic studies to improve knowledge of ovarian cancer biology and help in the selection of patients who will benefit most from the drug combination.
The study protocol was reviewed by the American regulatory agency, the US Food and Drug Administration (US FDA), through the special protocol assessment (SPA) process. The SPA procedure allows sponsors to obtain official written guidance from the FDA on pivotal Phase III clinical trials .
This study also was reviewed by the European regulatory agency, the European Medicines Evaluation Agency (EMEA), through a similar process called Protocol Assistance (PA).
"PharmaMar and J&JPRD are committed to developing YONDELIS expeditiously to enable it to be considered for the treatment of relapsed ovarian cancer patients who currently are considered to be incurable," said Dr. Miguel Ãngel Izquierdo, Director of Clinical Development at PharmaMar.
"There is a need to offer additional treatment options to help to control this disease, improve the quality of life and increase patient survival. Based on data from Phase II trials with YONDELIS as a monotherapy in relapsed ovarian cancer patients, and in Phase I trials with YONDELIS in combination with CAELYX (DOXIL), we believe we may be able to provide a new option to these patients."
In previous Phase II studies, YONDELIS demonstrated activity in ovarian cancer patients who had relapsed after standard first-line treatment. YONDELIS indicated a response rate, a significant reduction in the tumour, in those patients of up to 43%(1).
Liposomal doxorubicin (CAELYX(R)/DOXIL(R)) already has been approved for this therapeutic use in this patient population. As the combination of YONDELIS with CAELYX (DOXIL) also demonstrated activity and tolerability in a previous study(2), the studys theoretical premise is that the combination of two active drugs may improve the survival rate of the target patient population.
According to the American Cancer Society (ACS) in the United States and Western Europe, ovarian cancer represents 4% of all cancers among women and ranks fifth as a cause of female deaths from cancer. The death rate for this disease has not changed significantly in the last 50 years.
The median age of women with ovarian cancer is 60, although it may occur in younger women with a family history of the disease. Nearly 70% of women with epithelial ovarian cancer, the most common type of ovarian cancer, are not diagnosed until the disease is advanced. The 5-year survival rate for these women is only 15%-20%, whereas the 5-year survival rate for Stage I disease patients is nearly 90% and for Stage II disease patients is 70%.
In 2004, there were an estimated 25,580 new cases of ovarian cancer in the US, and more than 16,000 women died from the disease. Incidence in the European Union was about 48,000 new cases in 2004 and approximately 31,000 deaths (Globocan 2002, IARC, WHO). According to the World Health Organisation, the highest incidence rates occur in the United States, Canada, Scandinavia and Eastern Europe.
YONDELIS(R)
YONDELIS (trabectedin), is PharmaMars most advanced compound in development, and originally was isolated from the marine tunicate Ecteinascidia turbinata, but now is manufactured by chemical synthesis.
YONDELIS currently is being developed by PharmaMar in partnership with Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PharmaMar will market YONDELIS in Europe (including Eastern Europe) while Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., will market it in the US, Ortho Biotech, a division of Janssen-Cilag, will market it in the rest of the world.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C., Ortho Biotech Products, L.P. and Tibotec Therapeutics all are part of the Johnson & Johnson Family of Companies, the worlds most comprehensive and broadly based manufacturer of health care products.
YONDELIS(R) currently is also in Phase II studies in soft tissue sarcoma (comparative pivotal trial) and for prostate cancer.
In clinical studies to date, YONDELIS has shown a good safety and tolerability profile. The most frequent side effect is neutropenia, which is reversible and controllable. A transient increase in transaminases also has been observed.
YONDELIS is a new chemical entity with unique multicomponent mechanism of action. It is the only chemotherapy agent that binds to the DNAs minor groove and bends towards the major groove, producing its therapeutic effect by interfering with various cell division processes.
(x) DOXIL is marketed in the United States by Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., and in Israel by Janssen-Cilag. Schering-Plough Corporation, under a licensing agreement, has exclusive rights to market this medication as CAELYX(R) throughout the rest of the world, excluding Japan.
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