GHP Q3 2019

GHP / Q3 2019 23 Ground-Breaking Trial Demonstrates Potential Of Blood Test Adam Hill, Chief Executive Officer of Oncimmune, commented: “We are thrilled that the ECLS trial has demonstrated so clearly the potential of our EarlyCDT technology platform to transform the way cancer is diagnosed. We look forward to working with health authorities in Scotland and beyond to roll out EarlyCDT Lung more widely, with the aim of saving lives and reducing costs for the NHS and other healthcare systems around the world. Meanwhile, we are continuing to test our technology on other forms of cancer, including liver, ovarian, breast and prostate, in pursuit of our ambition to build the leading immunodiagnostic platform in the field of oncology.” Professor Frank Sullivan, Professor of Primary Care Medicine at the University of St. Andrews, the Chief Investigator for the ECLS trial, commented: “These landmark findings are likely to have globally significant implications for the early detection of lung cancer by showing how a simple blood test, followed by CT scans, is able to increase the number of patients diagnosed at an earlier stage of the disease, when surgery is still possible and prospects for survival much higher.” Details of the ECLS trial Today’s Presidential Symposium presentation at the IASLC World Conference on Lung Cancer builds on positive top line results announced in June and confirms that the ECLS trial met its primary endpoint. The trial was open to adults aged 50–75 considered to be at high risk of lung cancer because of smoking and family history, and healthy enough to undergo potentially curative therapy. The intervention was the EarlyCDT Lung test, followed by X-ray and computerised tomography (CT) scan in those with a positive test result. The comparator was standard clinical practice in the UK. The primary endpoint was the difference, at 24 months after randomisation, between the rates of patients with stage III, IV or unclassified lung cancer at diagnosis in the intervention arm and those in the control arm. There are also a number of secondary endpoints, details of which will be provided when the trial is fully reported. The trial was sponsored by the University of Dundee and NHS Tayside and co-funded by the Scottish Chief Scientist Office, Scottish Government and Oncimmune. It was headed by Chief Investigators Professor Frank Sullivan, Professor of Primary Care Medicine at the University of St. Andrews, and Dr Stuart Schembri, until recently consultant Physician in Respiratory and General Internal Medicine at NHS Tayside. The oral presentation was made by Professor Sullivan in the Presidential Symposium of the World Conference for Lung Cancer 2019, the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, hosting more than 7,000 delegates from more than 100 countries. A submission on the full ECLS trial is currently being prepared for a leading peer- reviewed medical publication. Background Lung cancer is the most common cause of death from cancer in Scotland. A quarter of all deaths from cancer in Scotland are attributed to lung cancer. The number of deaths due to lung cancer is more than double that of colorectal cancer, the next most common cause of death from cancer. 5,331 new cases of lung cancer were diagnosed in 2017 (2,592 males and 2,739 females) with 4,069 deaths from the disease recorded that same year.[2] In the UK, survival from lung cancer is poor with less than 9% of patients still alive at five years after diagnosis, due primarily to the late stage of presentation. Early detection and diagnosis of cancer improves prognosis; the current five-year survival rate is approximately 60% for stage I lung cancer but is only 1% for those with stage IV disease.[1] The US National Cancer Institute National Lung Screening Trial (NLST) reported that CT screening reduced lung cancer mortality by 20%. This has led to a number of guidelines in the United States which advocate lung cancer screening with low dose CT. More recently the UK Lung Cancer Screening Trial and the NELSON trial reported successful early detection of lung cancer using low dose CT scans. However, as a primary screening modality CT is expensive and leads to a significant percentage of false positives (>90% of lung nodules are found to be benign). There was a substantial increase in morbidity associated with further investigation. The EarlyCDT Lung test is a novel autoantibody diagnostic test for the early detection of lung cancer allowing stratification of individuals according to their risk of developing lung cancer. This could permit a targeted approach to CT scanning for early lung cancer detection which may be a more cost-effective and potentially less harmful approach to population screening. Notes [1]. Early Detection of Cancer of the Lung Scotland (ECLS): Trial results. (2019). IASLC 2019 World Conference on Lung Cancer. Abstract available from 10:15 CEST, 09 Sep 2019 https:// bit.ly/2ky8Glo [2]. Isdscotland.org. (2019). Cancer | Cancer Statistics | Lung Cancer and Mesothelioma | Health Topics | ISD Scotland. [online] Available at: https://www. isdscotland.org/Health-Topics/ Cancer/Cancer-Statistics/Lung- Cancer-and-Mesothelioma/ [Accessed 6 Sep. 2019].