There is little doubt that the age of personalized medicine is upon us. Companion diagnostics are now reaching the market and molecular testing in general is increasingly common, particularly in the field of oncology. UK based Almac Group has recently announced a partnership with Genomic Health who have exclusively licensed their DNA damage repair deficiency (DDRD) technology and intellectual property to further develop, validate and subsequently commercialize a multi-gene test to predict benefit from DNA damage-based chemotherapy drugs, such as the commonly used anthracycline-based regimens, in breast cancer.
Almac's Diagnostics business unit is focused on the discovery, development and delivery of biomarkers. The unit has two main focus areas, a service business that delivers biomarker services and companion diagnostic development for the Pharma industry and a research and development business developing prognostic and predictive tests for oncology indications.
This assay is the first product from several molecular subtype-based projects. Future assays …include a biomarker for angiogenesis which is undergoing validation in the ICON7 ovarian cancer trial and a biomarker for early prostate cancer...
The test covered in this agreement is specifically focused on predicting response to specific chemotherapy drugs and/or regimens, since treatment is often given in a “one size fits all” approach rather than being tailored for the patient.
The new test was developed by screening a population of breast cancer patients that was enriched with BRCA mutations. Gene expression profiling was carried out using Almac's Breast Cancer disease Specific Array or DSA, a microarray platform designed for biomarker discovery from standard FFPE samples. The resultant data was then analysed to identify a biological subtype which represented an inability to repair DNA damage.
Adjuvant and neo-adjuvant
An assay that prospectively identified this subtype predicted response to DNA damaging agents such as anthracycline-based chemotherapy in both the neo-adjuvant and adjuvant setting. Specifically, on multivariate analysis, a patient who was positive for the assay had a hazard ratio of 0.37 for disease recurrence following anthracycline-based chemotherapy. In the neo-adjuvant setting a DDRD assay positive patient was approximately 4 times more likely to have a complete pathologic response to this form of treatment.
Genomic Health will now identify a study cohort for the validation of Almac's previously identified and published genes. If validates, the assay has the potential to bring objectivity to the choice of treatment for patients with early breast cancer and could benefit approximately 70,000 patients in the USA and up to 200,000 patients in the USA and Europe.
This assay represents the first product from several molecular subtype-based projects being performed in Almac's research pipeline. Future assays that should be available within the next 2 years include a biomarker for angiogenesis which is currently undergoing validation in the ICON7 ovarian cancer trial, a randomized (1:1 ratio), 2 arm, multi-centre, Gynecologic Cancer InterGroup (GCIG) open-label phase III trial designed to evaluate the safety and efficacy of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with advanced epithelial ovarian or primary peritoneal cancer, and a biomarker for early prostate cancer that will be validated in a multicenter dataset throughout 2014.
For more information
Perren TJ, Swart AM, Pfisterer J, Ledermann JA, Pujade-Lauraine E, Kristensen G, Carey MS, et al. A phase 3 trial of bevacizumab in ovarian cancer. N Engl J Med. 2011 Dec 29;365(26):2484-96. doi: 10.1056/NEJMoa1103799.[Article][PubMed]
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