Drug giant Abbot has tied up with GlaxoSmithKline (GSK) to develop an automated molecular diagnostic test, based on polymerase chain reaction (PCR) technology. It will help scree screen non-small cell lung cancer (NSCLC) tumors for expression of the MAGE-A3 antigen. GSK's MAGE-A3 ASCI (Antigen Specific Cancer Immunotherapy) candidate is currently being evaluated as an adjuvant treatment in resected NSCLC in the Phase III clinical study MAGRIT, the largest lung cancer treatment study ever conducted.
To be eligible to receive GSK's MAGE A3 ASCI, patients must have MAGE-A3 expressing NSCLC tumors. MAGE-A3 is a tumor-specific antigen that is expressed in non-small cell lung cancer and a wide variety of other cancers, but not in normal cells.
Under terms of the agreement, Abbott, in conjunction with GSK, will develop and commercialize a PCR test designed to detect MAGE A3 for use on the Abbott m2000 automated instrument system.
Currently, there are no nucleic acid based tests approved by the U.S. Food and Drug Administration for use in identifying patients who may derive treatment benefits from targeted non-small cell lung cancer therapies.
"Lung cancer is the biggest cancer killer globally," said Vincent Brichard, vice president and head of Immunotherapeutics, GSK. "Through this partnership we aim to make MAGE-A3 testing of lung tumors available in standard pathology labs around the world. This means patients globally could be able to find out if they are eligible and can potentially benefit from targeted cancer treatment against this antigen, such as GSK's MAGE-A3 candidate ASCI."
GSK's ASCIs represent a novel class of medicines designed to train the immune system to recognize and eliminate cancer cells in a highly specific manner. These novel cancer immunotherapeutics combine tumor antigens, delivered as purified recombinant proteins, and GSK's proprietary Adjuvant Systems, which are specific combinations of immunostimulating compounds selected to increase the anti-tumor immune response. ASCIs are being investigated in the clinic to support their use to reduce the risk of tumor recurrence following surgery, or to impact tumor growth in an early metastatic setting. The highly specific mode of action of GSK's ASCIs allows development of diagnostic tools to aid in selecting patients eligible for the treatment, depending on the expression of the tumor antigens.
MAGE-A3 is a tumor-specific antigen that is expressed in a large variety of cancers, including melanoma, non-small cell lung cancer, head and neck cancer, bladder cancer, with no expression in normal cells. Expression of the MAGE-A3 gene has been observed in testicular cells but without antigen presentation capabilities. MAGE-A3 protein has been in-licensed by GSK from the Ludwig Institute for Cancer Research, the largest international academic institute dedicated to understanding and controlling cancer. MAGE-A3 ASCI is an investigational compound and it is not approved for use in any indication in any country at this time.
Websites have been created to provide information on the ASCI approach and the MAGRIT clinical study. Please visit www.immunotherapyforcancer.com and www.gsk-asci.com for more information.