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FORNY20-FORNY2020

KVAL: Development of Clinical assay to predict treatment response in breast cancer

Alternative title: Utvikling av klinisk test for prediksjon av behandlingsrespons ved brystkreft

Awarded: NOK 0.50 mill.

Project Number:

331600

Project Period:

2021 - 2022

Funding received from:

Organisation:

A common denominator for modern cancer treatment is the need for new methods that can predict which patients will benefit from available treatment, so-called precision medicine. This concept aims to provide the right medicine to the right person at the right time. So how can this goal be achieved? An important source of information are the molecules, in the form of, for example, mRNA and proteins, which define the composition of the tumour. By using data from clinical trials, we can use machine learning to find out which of these molecules can together form signatures that reveal which patients will achieve a good response to selected treatments. Using this method, we have created a predictive response signature called ViRP. This can predict which breast cancer patients should be offered treatment where the drug bevacizumab is given in addition to standard chemotherapy. Bevacizumab is an antiangiogenic drug that prevents the growth of blood vessels in tumors and has proven very efficient in the treatment of several types of cancer, with the exception of breast cancer. Due to the lack of general effect, this medicine is not offered to this patient group today, even though it is approved for use. Through this project, we have surveyed the market and interviewed clinicians in the US and Europe about how they assess the technology. This has enabled us to better understand how to position the product in the market and given us knowledge of requirements for the final product. Clinicians with long experience of treating breast cancer patients gave positive feedback on the technology, which provides evidence that the technology meets an unmet need in the market. With the aim of expanding use of our test to cancer forms other than breast we have secured access to data from two clinical trials in which bevacizumab has been used to treat colorectal and ovarian cancer patients. These are cancers in which bevacizumab is already in use, but also in need for identification of responding patients. We have drawn up a plan for further validation of the technology and set up a strategy for commercialization.

There is a need for a test that can stratify patients who will benefit from bevacizumab to reduce the imbalance in benefit versus side effect and potentially make the drug available to patients. According to the WHO, in 2021 breast cancer is the most common type of cancer globally, with new cases exceeding 2.3 million and more than 280 thousand in US alone. There is currently no test available on the market for the selection of BC patients for treatment including bevacizumab. Through this project, we have surveyed the market and interviewed clinicians in the US and Europe about how they assess the technology. This has enabled us to better understand how to position the product in the market and given us knowledge of requirements for the final product. Clinicians with long experience of treating breast cancer patients gave positive feedback on the technology, which provides evidence that the technology meets an unmet need in the market. Through collaboration with clinical study groups groups in Germany, we have obtained access to relevant clinical and molecular data from studies using bevacizumab treatment in colorectal and ovarian cancer patients. This is being used to explore possible use of our test in cancer forms other than breast. We have further started a prospective trial at Oslo University Hospital (NAPEER+) with support from AstraZeneca to validate clinical use of the ViRP test in a real-life patient treatment situation. We have drawn up a plan for further validation of the technology and set up a strategy for commercialization.

Funding scheme:

FORNY20-FORNY2020