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Clinical Trial to Test Advanced Lung Cancer Immunotherapy

Lung cancer X-ray

(National Cancer Institute)

7 April 2014. EMD Serono, a subsidiary of the pharmaceutical company Merck in Rockland, Massachusetts, is beginning a clinical trial to test a vaccine-type therapy for advanced cases of non-small cell lung cancer. The late-stage trial is assessing the ability of tecemotide, an experimental drug designed to trigger an immune response against cancer cells, to extend survival time of patients who already received concurrent chemo- and radiation therapy, but whose lung cancer cannot be removed by surgery.

Non-small cell lung cancer accounts for 85 to 90 percent of all lung cancer cases; the name refers to the size of the cancer cell when viewed under a microscope. This category of lung cancer has various sub-types, which are similar in treatment and prognosis.

Tecemotide is formulated as a vaccine to stimulate T-cells in the body’s immune system for controlling the growth and spread of cancer cells. It is made up of proteins that seek out the antigen MUC1, which appears on the surface of several types of cancer cells, including those of non-small cell lung cancer. Tecemotide was first developed by the biotechnology company Oncothyreon Inc. in Seattle, and licensed to Merck and EMD Serono for clinical trials and commercialization.

An earlier trial of tecemotide with patients having inoperable non-small cell lung cancer showed the therapy was about as successful in extending overall survival time as patients receiving a placebo. Patients in this first trial already received both chemo- and radiation therapy treatments, but the results showed longer survival times for those receiving tecemotide after concurrent chemo- and radiation therapy — median of 30.8 months — compared to the placebo (20.6 months). Patients receiving tecemotide after sequential chemo- and radiation therapies survived about as long as the patients receiving a placebo.

The new trial has a similar design as the earlier study, but in this case participants first receive only concurrent chemo- and radiation therapies, with the group of 1,000 non-small cell lung cancer patients divided about equally between those then receiving tecemotide or a placebo. Patients are being recruited in both the U.S. and Europe. A clinical study similar to the original trial is recruiting some 500 patients in China, Hong Kong, Taiwan, Singapore, and South Korea.

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