News Feature | January 24, 2014

Nektar's Etirinotecan Pegol (Nktr-102) Passes Interim Efficacy Analysis For Metastatic Breast Cancer

Source: Clinical Leader

By Cyndi Root

Nektar Therapeutics announced in a press release that an independent committee has recommended continuation of a clinical study for etirinotecan pegol (NKTR-102). The Independent Data Monitoring Committee (DMC) was formed to provide safety oversight for the BEACON trial for metastatic breast cancer. The phase 3 trial evaluates NKTR-102 for treatment of local and recurrent cancer. Howard Robin, President and CEO of Nektar Therapeutics said, "While the results of BEACON remain blinded to Nektar, we are very pleased that the NKTR-102 trial has successfully passed this important interim efficacy analysis.” 

Metastatic Breast Cancer

Metastatic breast cancer is cancer that has left the confines of the breast and spread to other parts of the body. Worldwide, one million women each year develop the breast cancer, with about 200,000 new cases annually in the United States. Approximately 12 percent of women will develop invasive breast cancer. About 40,000 women die from breast cancer each year, although due to earlier detection and treatment advances, those numbers may decrease.

The most widely used chemotherapeutic agents are anthracyclines and taxanes. Unfortunately, early use of these drugs often makes tumors resistant to later use if the cancer reoccurs, making treatment options for metastatic cancer limited. Topoisomerase I inhibitors like NKTR-102 are urgently needed to treat drug-resistant tumors. Currently, no topoisomerase I inhibitors are approved by the FDA to treat breast cancer.

Etirinotecan Pegol (NKTR-102)

NKTR-102 is a new long-acting topoisomerase I inhibitor that is receiving positive results from other studies. Its therapeutic action does not interfere with other chemotherapeutic agents. It is long-acting, delivering treatment consistently rather than in peaks and lows, thereby mitigating the risk of toxicity. Researchers believe that NKTR-102 enters the vasculature of the tumor environment more readily than normal vasculature, increasing penetration and concentration of the drug in the tumor.

NKTR-102 achieved a 29 percent objective response rate (shrinking tumor) and a six-month clinical benefit rate of 37 percent in the 14-day group and 49 percent in the 21-day group. Six patients experienced a full or partial resolution of target lesions. Side effects of neutropenia, alopecia, neuropathy, and diarrhea were low or manageable. Nektar expects final results in late 2014 or early 2015. If the results are positive, it plans to submit approval filings in the U.S. and Europe.

Source:
http://ir.nektar.com/releasedetail.cfm?ReleaseID=819189