Summary of the technology
Peripheral blood and its components (serum, plasma, and circulating cells) is an easily accessible fluid. An ELISA-based system that exploit circulating protein biomarkers found in this medium is more convenient to the patient compared to a more invasive lung biopsy. The researchers have found that high levels of serum hepatocyte growth factor (sHGF) protein in patients with SCLC shows clearly predicted for shortened survival and an incremental risk for death. HGF is a natural ligand for the oncogenic epithelial transition factor (c-Met) transmembrane tyrosine kinase receptor and serum HGF could be predictive of individual responses to new anti-cancer drugs: the Met inhibitors. The Met inhibitors are targeted therapies against c-Met receptor that are currently in development for the treatment of other neoplasms and are planned to be evaluated in SCLC. Therefore, a biomarker of prediction of response to these new Met inhibitors would be crucial for correct selection of patients for the clinical trials. Incorrect selection through other biomarkers in NSCLC has leaded to lack of benefit from these drugs in already performed phase 3 clinical trials, stressing the relevance of correct patient selection
Description of the technology
Researchers from the Hospital del Mar Medical Research Institute (Barcelona, Spain) have found a biomarker that is associated poor outcome in small cell lung cancer (SCLC) patients and might select patients that benefit from new targeted drugs. This marker can be measured by a simple, non-invasive enzyme-linked immunosorbent (ELISA)-based test. Only a blood sample from the patient is required.
One of the main technical advantages of this discovery is that the biomarker can be studied with a single blood sample obtained at diagnosis in a patient with SCLC. Other biomarkers suggested for the benefit of these anti Met drugs are performed in lung biopsies which are invasive procedures and could be harmful for the patient and are frequently small with limited available material when diagnosis is performd. Serum HGF levels are associated with c-Met activation features in the SCLC lung tumors. Thus a serum biomarker is predictive of the status of the tumor. Moreover, C-Met activation seems to be the best predictor of response to Met inhibitors in preclinical models and also in patient cases reported in the literature. Another technical advantage is that ELISA is a relatively simple procedure that could be performed in any laboratory throughout the world and therefore be applicable for routine hospital practice.
Main advantages of its use
- The use of this technology will have several benefits for the patient: (1) To refine at diagnosis the prognosis of a patient with SCLC; (2) To allow to select SCLC patient for anti-MET therapies. By dividing patients into different subgroups, treatment and follow-up can be tailored for each individual according to disease aggressiveness and the ability to respond to a certain treatment; (3) It is convenient for the patient and the physician as it can be performed in a peripheral blood sample; (4)It could substitute a lung biopsy that is an invasive procedure with potential complication and clear disconfort for the patient (5) It is performed with a technology ELISA that could be used in many laboratories in the clinical setting, thus it would be widely applicable, so commercially it could be very profitable
- Our technology could be relevant for the Pharmaceutical companies that have a pipeline of anti-MET drugs allowing the design of early clinical trials based on our biomarker. Success in the development of new molecular drugs is based on a proper design of clinical studies to take into account the actual variation between tumors and between patients, and that fact will influence and decide the sensitivity to treatment and self-tumor biology. Importantly, sHGF levels are associated with with c-Met activation features in the SCLC lung tumors. Thus, the identification of the predictive HGF biomarker correlates with the identification of the status of the target of the anti-MET drugs in the tumoral cells, and its study can be performed in paralel to the development of the inhibitors per se that the pharmaceutical companies are performing. The use of our technology, allowing the selection of patients that will enter to a specific clinical trail, may guatantiee a rapid development success and reducing the costs of development of such therapies.