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Trebananib Improves Progression-Free Survival in Recurrent Ovarian Cancer

According to a news statement released by Amgen pharmaceuticals, the targeted agent Trebananib (AMG386) in combination with chemotherapy improves progression-free survival over chemotherapy only in ovarian cancer. Mature data including overall survival is expected in 2014.

Approximately 70% of women with ovarian cancer are diagnosed once their disease is in advanced stages, since there is no approved routine screening method for the disease. Once in advanced stages (meaning the cancer has spread from its site of origin to other sites in the body), long-term survival or cure for ovarian cancer is approximately 20% with standard therapeutic approaches. Therefore, novel targeted therapies are being evaluated for treatment of ovarian cancer so that survival for this disease may be improved.

Trebananib is an agent that is not yet approved by the United States Food and Drug Administration (FDA). Its mechanism of action is referred to as angiopoetin inhibition, in which the drug reduces the ability of blood vessels of the cancer to grow and be strong. This, in turn, decreases the supply of nourishment to cancer and helps to inhibit its spread throughout the body. In addition, angiopoeitin inhibition is also involved in decreasing the formation of new lymph vessels which the cancer also uses as a means to spread to different sites in the body.

The recent trial evaluating trebananib is referred to as the TRINOVA-1 Trial. It is one of three phase III trials (phase III is the last phase of trials prior to FDA submission for approval) that is planned for the drug.

TRINOVA-1 included over 900 women from around the world with recurrent ovarian, peritoneal or fallopian tube cancer. The vast majority had ovarian cancer, and all 3 types of cancers are basically treated in the same way.

Women were treated with either the chemotherapy agent paclitaxel plus placebo (inactive substitute), or paclitaxel plus trebananib.

Median progression-free survival (survival with no progression of cancer) was 7.4 months for those who received trebananib/paclitaxel, and 5.4 months for those treated with placebo/paclitaxel.
The most common side effects associated with trebananib was localized swelling, nausea and loss of hair.
Although survival data will not mature until 2014, it appears at this time that the addition of trebananib to paclitaxel improves progression-free survival compared with paclitaxel alone among women with recurrent ovarian cancer. TRINOVA-2 and TRINOVA-3 are also phase III clinical trials that are evaluating trebananib in combination with other chemotherapy agents in recurrent ovarian cancer.

Reference: Amgen. Amgen Announces Top-Line Results Of Phase 3 Trebananib (AMG 386) TRINOVA-1 Trial In Recurrent Ovarian Cancer: Study Meets Primary Endpoint of Progression-Free Survival. June 12, 2013 press release. Available at: http://www.amgen.com/media/media_pr_detail.jsp?releaseID=1829205.