Researchers at the Cancer Research UK Southampton Clinical Trials Unit and the University of Leicester are running the NERO trial (Niraparib Efficacy in patients with unResectable MesotheliOma) to test whether a type of drug called a PARP inhibitor could be an effective treatment for mesothelioma patients.
PARP inhibitors have already been shown to improve the survival of patients with breast and ovarian cancers that carry specific mutations. They work by blocking a protein which helps repair damaged DNA in cancer cells, thereby causing the cancer cells to die.
Professor Gareth Griffiths, Director of the Southampton Clinical Trials Unit said: “There is an urgent need to explore more effective approaches and different therapies for this aggressive form of cancer.
“We recently published the results of the CONFIRM trial, the first study of its kind to show that an immunotherapy treatment improved survival for patients with mesothelioma. This was a huge breakthrough, and immunotherapy has now been included in European treatment guidelines for mesothelioma. But if patients fail on standard of care treatment mesothelioma remains an incurable disease and therefore further research into other treatment options, in addition to just active symptom control, is desperately needed.”
Mesothelioma patients whose tumours have progressed following chemotherapy and are therefore more likely to be susceptible to a PARP inhibitor, will be invited to join the NERO trial where they will be given a drug called niraparib.
Dean Fennell, Professor of Thoracic Medical Oncology at the University of Leicester and Chief Investigator of the NERO trial, says: “In a previous, small study called the MiST1 trial, we showed that mesothelioma does to respond to this type of drug, but further investigation is needed to test whether PARP inhibitors could be a new treatment option for patients. If the NERO trial is positive, this study will lead to the approval of a new medicine for use around the world, one that would extend the life expectancy of patients following initial chemotherapy.”
NERO will recruit 84 patients who have already had chemotherapy treatment at hospitals across the UK. Patients will be randomly allocated into one of two arms within the trial, with a 2:1 chance of receiving niraparib so that the researchers can compare the effect of the drug on the tumour. Those patients who do not receive niraparib will be closely monitored for signs of early tumour growth so that they can go on to receive an alternative treatment if necessary.
NERO is funded by Asthma and Lung UK and developed in collaboration with Mesothelioma UK, with additional support from Cancer Research UK core funding at the Southampton Clinical Trials Unit.
For details on the NERO trial, visit www.southampton.ac.uk/ctu/trialportfolio/listoftrials/nero.page.
Details on the CONFIRM trial can be found at www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00471-X/fulltext
Details of the MiST1 trial, which can be found at www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30390-8/fulltext