Article perview reprinted from IN VIVO - July 2009
GSK's first immunotherapy is still 4-5 years away, but it is already commissioning a companion diagnostic for it. By striking a deal with Abbott for a commercial screening test this early, the pharma may be laying the groundwork to address any regulatory concerns around using the test to enrich its clinical trials populations, which could allow for lower numbers of patients to be enrolled in order to prove efficacy. Read more...
GSK's Early Link-Up with Abbott for an Immunotherapy Companion Diagnostic
Article perview reprinted from IN VIVO - July 2009
Commercialization of GlaxoSmithKline PLC's first product from its Antigen Specific Cancer Immunotherapy (ASCI) program is still at least several years off, but the company is already commissioning a companion diagnostic for it. It has enlisted Abbott Laboratories Inc.'s Abbott Molecular Inc. to develop a PCR-based test to screen non-small cell lung cancer (NSCLC) tumors for expression of MAGE-A3, an antigen found on NSCLC, melanomas, and other solid tumors. By striking a deal for a screening test this far in advance of commercialization, GSK may be laying the groundwork to address any regulatory concerns around using an enriched clinical trial population, anticipating a data package for approval based on a rapid and probably more responsive clinical trial owing to the use of the screening test, which could allow for lower numbers of patients to be enrolled to prove efficacy.
Like most immunotherapy endeavors, ASCI is a long-term bet for GSK. The firm had been collaborating since 1995 with the Ludwig Institute for Cancer Research on the identification of antigens for therapeutic cancer vaccines, and ten years ago, it seeded ASCI, thinking it could blossom in the 2020-2030 timeframe. MAGE-A3, a melanoma antigen not expressed in any normal cells (except in the testes, and there only internally, where it cannot be recognized by T cells), is the program's lead candidate. GSK is currently enrolling patients in two global Phase III studies of its MAGE-A3 ASCI therapeutic vaccine: one in NSCLC and a second in melanoma. The more advanced, the MAGRIT lung study set to measure time to relapse following surgery and administration of MAGE-A3 ASCI, is expected to complete enrollment of 2,270 patients in 2011. An approval, therefore, is easily 4-5 years out.
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Companies mentioned in this article:
Ludwig Institute for Cancer Research
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