Morphotek®, Inc., a subsidiary of Eisai Inc., announced that it has commenced a multi-center phase II study of farletuzumab in adenocarcinoma of the lung, a type of non-small cell lung cancer (NSCLC). The study will evaluate farletuzumab, a monoclonal antibody that specifically binds to folate receptor-alpha (FRA), with the physician's choice of one of three standard platinum-containing doublets that are approved and recommended for first-line metastatic lung cancer patients.

The trial is designed as a randomized, double-blind, placebo-controlled study to determine if farletuzumab delays the time to tumor progression when it is added to one of the standard-of-care chemotherapy options for metastatic adenocarcinoma of the lung. Secondary objectives include safety, response rate and duration of response, and overall survival benefit of patients treated with the antibody plus chemotherapy versus the chemotherapy with a placebo. The patient population includes individuals with advanced NSCLC adenocarcinoma who have tumors that over-express FRA and have not received any prior radiation or chemotherapy for curative intent of their disease. It is estimated that about three-quarters of adenocarcinoma of the lung are FRA-positive.

Morphotek expects to enroll up to 120 patients in this clinical study, which is being conducted at clinical centers globally. As part of the study, a Morphotek-developed diagnostic kit will be used to determine patient eligibility.

"We are excited to have initiated this global phase II study of farletuzumab in cooperation with leading physicians. Since farletuzumab targets FRA, this personalized approach will include only those patients who could potentially benefit from therapy with the new agent," stated Julia Maltzman, M.D., Senior Director of Clinical Development at Morphotek. "NSCLC has a generally poor prognosis, so we hope that farletuzumab may one day provide a benefit to patients with FRA-positive NSCLC."

Farletuzumab is a monoclonal antibody that binds to and blocks the function of FRA, a cell surface protein on tumor cells that confers a growth advantage to tumorigenic ovarian cells in vitro. FRA has been demonstrated by several independent studies to be expressed on a variety of cancer types including non-small cell lung adenocarcinoma. Preclinical data support the theory that farletuzumab achieves its pharmacological effect by two mechanisms: first, by the capacity of farletuzumab to block signaling inside cancer cells and, second, by stimulating the patient's immune system to attack and destroy the FRA-positive tumor cells.

Lung cancer is the leading cause of cancer death worldwide. NSCLC represents more than 85% of lung cancer cases, with the majority being diagnosed in advanced stages. Estimates for lung cancer in the United States are predicted to be over 220,000 new cases and 155,000 deaths from the disease annually.(1) Over 360,000 deaths from lung cancer are expected annually in the European Region. Approximately 15% of patients in these regions with NSCLC will survive five years, reflecting the limited potential of currently available therapies.(2)

(1) Jemal A., et al, Cancer Statistics 2010, CA Cancer J Clin 2010; 60;277-300

Source: Morphotek, Inc