A multi-center phase II study will evaluate farletuzumab (Morphotek, Inc., a subsidiary of Eisai Inc), a monoclonal antibody that specifically binds to folate receptor-alpha (FRA), in adenocarcinoma of the lung, a type of non-small cell lung cancer (NSCLC), in combination 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.

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]

Monoclonal antibody
Farletuzumab, also known as MORAb-003, is a humanized IgG1 (monoclonal) antibody that binds to and blocks the function of Folate Receptor-alpha (FRA), a glycosylphosphatidyl-inositol-linked cell surface protein which is over-expressed on a number of epithelial-derived cancers, confers a growth advantage to tumorigenic ovarian cells in vitro and 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.

The drug has received orphan drug designation by the FDA for ovarian cancer.

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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.

No prior radiation or chemotherapy
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.

A global trials
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.

A personalized approach
“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.”

[1] Jemal A., et al, Cancer Statistics 2010, CA Cancer J Clin 2010; 60;277-300
[2] Lung Cancer Incidence and Mortality Worldwide. Last viewed June 28, 2011.

For more information:
Clinical Trials
– A Safety and Efficacy Study of Farletuzumab in Subjects With Adenocarcinoma of the Lung [NCT01218516]
– An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer [NCT00738699]

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