Oncimmune Holdings plc (LON:ONC) is a pioneering UK-based biotechnology company which has developed a blood test for the early detection of lung cancer (using its EarlyCDT® platform which measures autoantibodies against specific panels of tumour-associated antigens). This morning the company announced that later today it will be presenting an update on the progress of the ECLS study which is the largest randomised controlled trial ever conducted evaluating the use of blood-based biomarkers (EarlyCDT®-Lung) for the early detection of lung cancer in individuals at high risk of developing the disease. The update will be presented at the 17th World Conference on Lung Cancer, organized by the International Association for the Study of Lung Cancer, currently being held in Vienna, Austria.
By the end of June 2016, the ECLS trial had enrolled over 12,200 participants in Scotland into the study making this the largest randomized controlled trial for the early detection of lung cancer using biomarkers ever conducted. ‘High risk’ of developing lung cancer is defined by certain criteria including age (50-75 years) and smoking history (current or ex-smoker with at least 20 pack year history), among others. All participants consented to have a blood sample taken at the initial study visit and these were randomized to be tested or not. Blood samples from the control group are not tested. At the end of the study, the occurrence of lung cancers in the control group of participants (diagnosed according to standard practice) will be used as a comparator to determine the effectiveness of the EarlyCDT®-Lung blood test. Blood samples from 6,092 participants were randomized to be tested using EarlyCDT®-Lung. Each participant with a positive test is followed for a minimum of 2 years after the blood sample (those enrolled earliest will be followed for longer). Participants with a positive EarlyCDT®-Lung test receive a chest X-ray and low dose CT scans every 6 months.
Of the 6,092 participants in the test group, 5,487 EarlyCDT®-Lung tests were negative and 599 were positive (9.8%). To date, 2,058 CT scans have been performed revealing lung nodules in 275 participants. A total of 16 cancers have been diagnosed with 12 of these being early stage. There is also 1 participant undergoing further investigation.
Zeus Capital Comment: Today’s ECLS update provides further detail on how this landmark study is progressing. An important feature of the performance of EarlyCDT®-Lung is the stage shift which has been demonstrated in other studies and has similarly been noted in the ECLS trial (75% early stage). This means that cancers detected using EarlyCDT®-Lung are more likely to be stage 1 or 2 than cancers detected in standard practice (only 20% early stage at diagnosis). Such stage 1 or 2 cancers can be more effectively treated (surgery ± limited chemotherapy) at lower cost with better outcomes (lives saved). Given the stage shift it is possible that some cancers will not appear in the test positive group until after the minimum 2 year follow-up period. Nonetheless, we expect more cancers to emerge over the next 12-24 months.
If the test continues to deliver such strong performance it is possible that the NHS, and indeed other national healthcare agencies, could be prompted to offer the EarlyCDT®-Lung test as a nationwide lung cancer screening test in high-risk individuals. As a reminder, we do not include sales under such a scenario in any of our forecasts.
- Data remain encouraging with early detection of lung cancer four times more likely with EarlyCDT-Lung followed by CT screening than current standard of care
- The trial is now fully recruited with over 12,000 patients; largest randomised trial for the early detection of lung cancer using biomarkers ever conducted
- Final results may enable the adoption of EarlyCDT-Lung screening in the UK and by other countries
The interim results of the study, which is now fully recruited with 12,210 patients, showed that 599 (9.8%) of the test group had a positive test with 275 found to have lung nodules larger than 8mm. 16 lung cancers have been detected, 12 (75%) of which are early stage.
At present, approximately 20% of lung cancers are detected incidentally at an early stage, for example, during a scan for heart disease, however, the remaining 80% present symptomatically, which may be up to four years after it could have been detected by the EarlyCDT-Lung test followed by CT screening.
The test continues to show high sensitivity, however, it should be noted that the control arm has not been formally assessed. The final study results, including the control arm, will be published after all patients have had two years of follow up CT scans and these are expected in 2019.
These study results will enable the NHS to make a decision about whether to offer the EarlyCDT-Lung test as a nationwide screening test in the future and may enable the adoption of EarlyCDT-Lung screening by other countries.
The poster session presentation by Professor Frank Sullivan, “An RCT of the Detection of Autoantibodies to Tumour Antigens in Lung Cancer Using the EarlyCDT-Lung Test in Scotland (ECLS) in 12,210 Study Subjects (ID 4546)”, is scheduled to take place today at 2.30pm CET in Hall B, Messe Wien Exhibition & Congress Center, Messeplatz 1, A-1021 Vienna.
Professor Frank Sullivan, Chief Investigator of the ECLS Study said: “The ECLS Study is now fully recruited with over 12,000 patients. The results continue to be very encouraging and suggest it could be possible to detect early stage lung cancers sooner than with current methods. We look forward to completing the study and presenting full results, including the control group, after the full follow up period.”
Geoffrey Hamilton-Fairley, CEO of Oncimmune Holdings plc, commented: “Today’s positive interim data add further to the growing evidence that the EarlyCDT-Lung test has the potential to play a significant role in the early detection of lung cancer and save lives and money. EarlyCDT-Lung can detect cancer up to four years earlier than other methods allowing cancers to be found at Stage 1 or 2, meaning that patients can be treated with surgery and not require any (or only limited) chemotherapy, reducing morbidity rates and significantly lowering the cost of treatment.”
First announced in March 2012, the ECLS Study is designed to determine whether use of the EarlyCDT-Lung test as a screening method leads to earlier detection of lung cancer and can help to save lives in the long term. The study will also asses the health economics to see how cost effective EarlyCDT-Lung will be as a primary screening test. The rationale is that patients pre-identified as being at high risk of lung cancer take the EarlyCDT-Lung test. Those who receive a positive result are effectively triaged into a much higher risk group and are referred for X-ray and Low Dose Computed Tomography (LDCT). This high-risk selection protocol results in many fewer LDCTs but it is expected to still deliver the same mortality benefit that National Lung Screening Trial (NLST) in the USA has established.