Monitoring treatment response still challenging
With more than 3 million new cases and 1.7 million deaths each year, cancer represents the second most important cause of death and illness in Europe, after cardio-vascular disease. New, more targeted treatments are emerging and a significant proportion of cancers can be cured or at least their progression can be slowed, especially if they are detected early. However, one of the main problems for doctors and patients remains monitoring the response to treatment in real time and detecting potential tumour mutations which can lead to drug resistance.
Cancer clues hiding in the blood
Currently tissue biopsies are used to diagnose and monitor the disease, but doctors cannot perform these too often because they are invasive, costly, and often risky for the patient. However, cancer is a highly dynamic disease and real-time diagnostic evaluation is very much needed to determine the best personalised treatment for patients at a given time.
Tumours shed cells and fragments of DNA into the bloodstream and these ‘biomarkers’ can potentially be used to non-invasively screen for early-stage cancers, monitor responses to treatment and help explain why some cancers are resistant to therapies. Technical advances over the last two decades have enabled the extraction of these biomarkers from the blood, in a process which is called ‘liquid biopsy’. Although promising, this new method is not without challenges: looking for these biomarkers in the blood is often like looking for a needle in the haystack made up of billions of normal blood cells. Furthermore, a comprehensive evaluation, validation and head-to-head comparison of these new technologies have not yet been done. IMI’s CANCER-ID helped to fill this gap.
By bringing together companies and institutions in the fields of tumour biology and cancer therapy, biomarker development, clinical sciences and bioinformatics, as well as regulatory agencies and patient advocacy groups, CANCER-ID compared, evaluated and validated the most promising non-invasive technologies for liquid biopsy. With its over 30 partners from across Europe / the world, this project will bridge the gap between research focused on these novel methods and validating the most mature technologies so they can be adopted and brought to the patients as soon as possible.
The project will be divided into three key phases:
- In the pre-evaluation phase, liquid biopsy technologies will be evaluated and the criteria will be set for any of the technologies to move to the next phase.
- In the technical evaluation phase, the technologies identified as promising will be tested on patient samples.
- In the third stage, validated methods will be used on patients as part of clinical studies.
Lung and breast cancer as pilots
Validating these new technologies on all cancer types would be unmanageable. That’s why the project will focus on two-types of cancer: lung and breast cancer. Between them, lung and breast cancer account for approximately 760 000 new cases of cancer per year in the EU and are responsible for more than 50% of cancer-related deaths in women. Blood-based diagnostics will be important to improve treatment and to design new clinical trials in these patients.
More specifically, these two types of cancer have been selected for the following reasons:
- Lung cancer is the most common cause of cancer-related deaths worldwide. In the EU, lung cancer is the leading cause of cancer death among men in all countries except Sweden and women die from lung cancer more commonly than from breast cancer in a growing number of countries. Treatments with targeted drugs perform better than traditional chemotherapy. However, one obstacle is the difficulty in obtaining serial biopsies to chart tumour evolution and the emergence of drug resistance. For these reasons, CANCER-ID has selected lung cancer for development, optimisation and standardisation of the liquid biopsy biomarkers.
- Breast cancer is the most common malignancy in women. Although several therapeutic options are readily available, resistance to these therapies often significantly limits the success rate. HER2 is the most prominent molecular target in breast cancer and it defines a clear molecular subtype. In CANCER-ID, researchers will focus on breast cancer patients who failed to respond to HER2-targeted therapies. Resistance to HER2-targeted therapies represents a serious medical problem and there is an urgent need to develop novel diagnostic tests for the early detection of resistance.
Both patients and industry to benefit
Once validated and approved for use in patients, these new methods will have a significant value for patients, physicians and payers since they will prevent exposure of patients to drugs that are unlikely to be beneficial. Moreover, validated biomarker tests will be extremely important for the pharmaceutical industry as they will help reduce the very high dropout rate in clinical development by selecting the right patients for the right drugs.