Harnessing the Immune System for Early Cancer Detection

With the number of new cancer cases worldwide per year predicted to rise to 23.6 million by 2030, it seems as pertinent as ever that the disease is stopped early in its tracks. The value of early detection of cancer is evident: 90% of lung cancer patients will survive for five years if diagnosed at the earliest stage, compared to around 6% for those diagnosed at the most advanced stages of disease.

At the World Conference on Lung Cancer, Oncimmune announced positive results from a trial utilizing a simple blood test for early detection of lung cancer. The Early detection of Cancer of the Lung Scotland (ECLS) trial tested the validation of EarlyCDT Lung, Oncimmune’s early detection technology. We spoke with Mike Fisher, Ph.D., Commercial Director of Oncimmune, to find out more about the ECLS trial and EarlyCDT Lung.

Holly Large (HL): Why focus the EarlyCDT technology on lung cancer, as opposed to other forms of cancer?

Mike Fisher (MF): Lung cancer is the second most prevalent cancer yet the largest killer. Currently around 75% of lung cancers are diagnosed after the cancer has spread and the outcomes are poor. Computerized tomography (CT) screening has been shown to reduce mortality, and we have developed EarlyCDT Lung to be complementary to this, either by helping to assess the risk of people identified with lung nodules where it is unclear as to whether the nodule is benign or malignant, or by identifying high-risk patients that need to receive lung cancer screening by CT scanning. The ECLS trial shows that by screening these patients, we can reduce the number of late stage diagnoses and therefore improve the outcomes for lung cancer patients. We are looking at other cancers, with liver cancer being our second test and further cancers in our research pipeline.

HL: The EarlyCDT Lung test uses biomarkers in the blood to detect cancer — can you explain in more detail how this works, particularly in reference to autoantibodies and how they are detected?

MF: Oncimmune’s EarlyCDT Lung test uses the smartest disease detection system we know of — our immune system — to detect the presence of the cancer. In this way, we can see a high signal even if the tumor is very small. As the immune system produces a large number of antibodies in response to the cancer, we can measure these biomarkers simply using a common detection platform, known as an enzyme-linked immunosorbent assay, or an ELISA. This is an assay format that is widely used around the world and allows the test to be run in any clinical laboratory with minimal equipment requirements.

HL: Current methods for diagnosis rely primarily on the use of CT scans — one of the conclusions made from the trial is that lung cancer could be diagnosed at an earlier stage using a combination of the EarlyCDT Lung test and follow-up CT scans. What are some of the advantages of the proposed method over using CT scans alone?

MF: CT screening has been proven to reduce mortality in high-risk populations, and EarlyCDT Lung can be complementary to this. EarlyCDT Lung can be used to identify people for CT screening where CT scanner resources do not allow for widespread CT screening, or to identify people that are at higher risk than their smoking history and age alone would imply, and so would not normally be eligible for CT screening. In addition, EarlyCDT Lung can be used for patients that for various reasons would not come forward for CT screening. At 5%, the adoption rate of CT screening in the USA is very low. A blood test appears to be more acceptable as a first test in Scotland, with ECLS demonstrating that >15% of people accepted their invitation and joined the trial.

Where CT screening is available, EarlyCDT Lung can help assess the risk of lung nodules that are detected (should the CT scan alone be inconclusive), allowing the clinician to focus on the higher-risk patients and intervene more quickly than they would normally.

HL: What are some of the next steps (and potential hurdles) in translating the results of this trial into everyday clinical care?

MF: In order to gain mainstream adoption of EarlyCDT Lung for screening and/or as a test to rule people into CT screening, we need to prove the encouraging initial mortality benefit results demonstrated by ECLS. We are in negotiations for a larger roll-out of the test to over 100,000 people in Scotland — a number high enough to definitively prove any mortality benefit.

For the assessment of indeterminate pulmonary nodules, we have submitted data on the use of the test to the National Institute for Health and Care Excellence (NICE), who assess new technologies for their utility and cost-effectiveness in the NHS. We are also looking at piloting the use of the test in a number of NHS trusts to provide data on local use of EarlyCDT Lung.

HL: In an earlier press release, Adam Hill, Chief Executive Officer of Oncimmune, mentioned that the EarlyCDT technology is being tested on other forms of cancer — what are some of the factors affecting which form will be focused on?

MF: EarlyCDT is a platform technology, and by changing the autoantibodies measured, we can detect different cancers. We aim to focus on the cancers where there is a high unmet need in early diagnosis. Our second test is for liver cancer, and we have tests in our research pipeline looking at a number of solid tumors, such as prostate, breast and ovarian cancers.

HL: Could the principles of EarlyCDT Lung be applied to other diseases and how?

MF: Autoantibodies are also involved in autoimmune diseases, and we are studying these also. We are working with a number of pharmaceutical companies on profiling autoantibodies to characterize these diseases and help determine how patients should be treated. In addition, we are working with biotech and pharmaceutical companies to study autoantibodies as a method of assessing whether patients will respond or have an adverse reaction to immuno-oncology therapeutics. We see this as an exciting area, as by studying the immune system, we can predict how a patient might react to immune modulation therapies and therefore we can be more confident that patients can receive the right treatment at the right time.

Mike Fisher was speaking to Holly Large, Editorial Assistant, Technology Networks