EXPECTED POTENTIAL IMPACT

The expected value of this project is to identifying predictive factors of immune-related adverse events (irAEs), and discover whether these factors are different according to biology (sex) and gender-related characteristics. This is of great value for cancer patients who are being treated with immunotherapeutics. A key challenge in modern oncology is to match patients with the particular targeted drug most likely to improve their outcome, whilst not being associated with serious adverse treatment events. This project will test our hypothesis that sex and gender related factors play a role in a patient’s response to immunotherapy and the occurrence of irAEs. The study results, being obtained in a “real world” (outside experimental clinical trial setting), will be more easily translated in a ready to use irAEs timely diagnosis and personalization of treatment approaches. The results of our study will also provide actionable knowledge in the following areas: a. Translating our findings towards better clinical practice. We will use the information gathered in the project to determine which patients are likely to suffer from immune related adverse events when they recieve immunotherapeutics.  This information will be of especial importance to both pharmaceutical companies and clinicians, as it will allow them to identify a personalised treatment for patients who will undergo treatment with immunotherapeutics. Towards completion of our project we will engage with pharmaceutical companies to discuss how our results can be utilised to inform selection for future clinical trials.
b. Accelerating the translation of biomedical research results towards clinical validation: The results of our specimens testing will potentially identify novel biomarkers of response to immune checkpoint inhibitors and provide a pathway to identify those patients who will likely suffer from irAEs.  By using a highly coordinated approach we can facilitate the fast-tracking of the clinical testing of either DNA/RNA alterations in patients as predictors of IRAEs. Indeed, this project offers a unique opportunity to pharmaceutical companies/research groups to demonstrate an actionable pathway that uses clinical biospecimens to directly inform patient recruitment to future clinical trials.