Firm will develop qPCR-based multigene expression assay to help identify melanoma and NSCLC patients most likely to benefit from therapy.
Life Technologies will develop a companion diagnostic for use alongside GlaxoSmithKline Biologicals’ (GSK) investigational antigen-specific cancer immunotherapy (ASCI) MAGE-A3. The candidate is currently undergoing Phase III development as an adjuvant therapy against resected non-small cell lung cancer (NSCLC), and as an adjuvant treatment in lymph node-invasive melanoma (the Derma study).
Under terms of the agreement, Life Tech will use its Taqman® Array Card (TAC) technology to develop a multi-gene expression qPCR-based molecular diagnostic to help identify patients most likely to benefit from MAGE-A3 therapy. The firms aim to work together to validate the test in the current Phase III trial, and submit it for FDA premarket approval.
The Phase III Magrit NSCLC trial evaluating MAGE-A3 immunotherapy is the largest lung cancer treatment study ever conducted, GSK claims. Data from a Phase II study in NSCLC patients showed that MAGE-A3 immunotherapy led to a 25% reduction in the rate of cancer recurrence following surgery, at 44 months.
GSK has a MAGE-A3 diagnostic test collaboration in place with Abbott, centered on development of PCR tests for use on the Abbott m2000™ system. The firms’ deal to develop a PCR-based diagnostic to detect MAGE-A3 in melanoma biopsies was signed in March 2010. In June 2009 they inked a similar collaboration and began Phase III investigation for the MAGE-A3 marker in NSCLC.