Today, new treatment approaches such as immunotherapy and molecularly targeted therapies have begun to change the landscape for cancer treatment. This has resulted in dramatic improvements in long term survival rates compared with conventional chemotherapy, but the benefit has only been realized in a subset of patients.
At the same time, many promising cancer therapeutics are failing in late-stage clinical trials. However, pronounced effects seen in small numbers of study participants suggest that by better identifying responders we could drive greater success.
Recent regulatory trials confirm this with higher approval rates (25.9%) for drugs developed using response identifying biomarkers as compared to drugs without such biomarkers (8.4%). (Clinical Development Success Rates: 2006-2015, BIO, Biomedtracker, Amplion)
We believe that by targeting biological subtypes, drug developers could increase clinical development success for new therapies while expanding indications for existing drugs and achieving better patient outcomes overall.Read more ...
At this time, established biomarkers tied to specific drug mechanisms or disease pathways have not been widely successful or consistently reliable in identifying responder populations. Many cancers have proven too complex and heterogeneous. For example, PD-L1 levels have not proven to be a consistent predictor of PD-1 inhibitor efficacy. Recent clinical trial failures involving inhibitors of PD-1 in patients with PD-L1 expression suggest that the responder profile is more complex than expression of a single molecule. (Nivolumab in First Line or Recurrent Non-Small Cell Lung Cancer, Carbone, D.P., NEJM, June 22 2017)
Similarly, some targeted therapies have produced significant responses in patients where the drug’s target is not (over) expressed. For example, EGFR-directed therapies have demonstrated efficacy in patients lacking EGFR mutations. (Zhu CQ, da Cunha SG, Ding K, et al: Role of KRAS and EGFR as biomarkers of response to erlotinib in National Cancer Institute of Canada Clinical Trials Group Study BR.21. J Clin Oncol 26:4268-4275, 2008.)
GeneCentric’s Cancer Subtyping Platform (CSP®) represents an innovative, more systematic approach that we believe promises to improve drug developers’ ability to successfully align the right therapeutic compounds with the right patient populations and ultimately to have the most positive impact on patient outcomes.Read more ...
GeneCentric’s Cancer Subtyping Platform (CSP®) builds on the pioneering laboratory work of co-founders, Charles Perou, PhD., and Neil Hayes, MD, MPH, MS, innovators in the molecular characterization and treatment of cancer.
By applying CSP technology, GeneCentric is developing universal drug response biomarkers to enable more effective and efficient drug development informed by high resolution, genomic-defined cancer subtypes.
By applying Cancer Subtyping Platform (CSP®) to specific types of cancer, GeneCentric has developed and is expanding on its’ portfolio of universal cancer subtypes/biomarkers – what we call ‘Profilers’ – for some of most prevalent and complex cancers. CSP Profilers in the areas of lung cancer and head and neck cancer are available for immediate use.