I3LUNG Project: Leveraging Immunotherapy and AI to Revolutionize Lung Cancer Treatment

Lung cancer is known for its aggressiveness. In recent years, new hopes have arisen for patients with the advent of immunotherapy, a new treatment approach consisting in stimulating the patient’s own immune system. In lung cancer, this passes through the administration of specific drugs targeting immune checkpoint inhibitors (ICI). ICIs stop the interactions between cancer cells and specific proteins present in immune cells that prevent the latter from recognizing the cancer cells as harmful – the idea is to switch the immune system “back on”, help it identify cancerous cells and in turn fight them more effectively.

The idea came about after 2018, when James Allison, head of the department of immunology at the Anderson Cancer Center in Houston, and Tasuku Honjo, head of the department of immunology and genomic medicine at Kyoto University, were awarded the Nobel Prize for discoveries that paved the way for immunotherapy to fight advanced cancer.

Lung cancer (and in particular non-small cell lung cancer – NSCLC) immunotherapy has had success mainly through the two ICIs that are PD-1 and PDL-1 inhibitors, but it is important to note that (1) their efficacy could be better (2) not all patients respond equally to the treatment, for reasons still not well clarified. These are the core unmet needs that the I3LUNG project, and INT as a participating center, want to respond to provide an answer to. Specifically, by creating a dataset made up of different biomarkers (a meta-biomarker) that when put together can accurately predict a patient’s response to immunotherapy. These markers will be identified by looking at the results of the clinical studies conducted within the broader I3LUNG research project, whose data we will analyze with the help of Artificial Intelligence models designed ad hoc for this task.

In the first year of the project, aside from coordinating the project the Istituto Nazionale dei Tumori di Milano (INT) has been active in steering the design and creation of an original and unique electronic database to input and analyze clinical, epidemiological, molecular and radiological data at multiple levels, that has been populated with the data from over 1500 (so far) NSCLC patients collected by the clinical partners of the project. In parallel to the collection of retrospective data, the INT has designed and kick-started a prospective study enrolling 200 patients from five cancer centers, whose data will be collected and analyzed according to the AI methodologies we will implement from the autumn of 2023 onwards. The institute will be responsible for a set of clinical and biological analyses as well, in particular the analysis of patients’ microbiota and microRNA.

This project is already having a positive impact at a larger level at the Institute, with the constitution of a multidisciplinary team comprising physicians, bioengineers, nurses, biologists, data managers, pharmacists and project managers. This has been especially useful to create links, integrate the different skills and coordinate the progress of the project in the best possible way. A strong interaction is also being built with other related projects, such as the Apollo 11 network, 40+ Italian cancer centers that will share data through harmonized AI procedures, and share samples through an innovative “virtual biobank” design.

Spurred by this project, the idea of INT setting up Italy’s first Artificial Intelligence in Oncology Laboratory has emerged. It will be concretized with its creation in 2023 in the Institute’s Cascina Rosa Campus, already home to the its Data Science department.

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