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9th December 2021
Cancer experts set out a series of findings on 9 December 2021 on the barriers to carrying out clinical trials in the UK, and proposals for boosting participation by enhancing information, changing treatment pathways and streamlining regulations.
The Institute of Cancer Research (ICR), London, is publishing a report collating data on cancer trials, and the views of patients and clinicians on how barriers to making trials more widely available can be overcome. It is warning that without urgent action to open up clinical trials to patients more widely and earlier in treatment, huge opportunities could be missed to drive improvements in outcomes.
Figures obtained from the National Institute for Health Research show that the number of patients recruited onto clinical trials for cancer in England fell to 27,734 in 2020/21, down from an average of 67,057 over the three years previously. The number of patients recruited onto trials fell for almost every type of cancer analysed.
The ICR also published findings showing that issues with making clinical trials available to patients are longstanding and go far beyond the COVID-19 pandemic.
An interview-based study of 12 leading clinical trial researchers from across the UK commissioned from health charity Picker found strong agreement that more needed to be done to widen access to clinical trials for cancer patients. The study, carried out from April to July 2020 during the early part of the pandemic, identified the following issues:
The ICR also commissioned a YouGov survey of 500 people who had been treated for cancer, which was carried out in March 2020. It found that 95% of respondents thought it was important that cancer patients were offered access to treatment in clinical trials. But only 37% had had a conversation about clinical trials during their own treatment, and just 11% participated in a trial. There was also a difference in ability to access trials in different parts of the country, with some patients in rural areas reporting travelling more than 100 miles for treatment on a clinical trial. In light of the barriers identified, the ICR is calling for the following:
Professor Udai Banerji, Deputy Director of the Drug Development Unit at The Institute of Cancer Research, London said: “Cancer medicine has changed hugely over the last two decades, with patients increasingly treated with precision drugs targeted against particular genetic faults within tumours. It’s essential that our clinical trial systems keep pace with the science.
“We need streamlined and accelerated approval of promising drugs using novel trial designs. Clinical trials of drugs should be embedded into all aspects of cancer medicine from prevention, curative or non-curative therapy to palliative care. The pandemic has caused us to pause and identify areas we can do better. It’s time to make up for lost time.”
Professor Kristian Helin, Chief Executive of The Institute of Cancer Research, London, said: “Clinical trials have huge benefits for patients, both by providing access to the latest drugs and technologies, and by demonstrating the effectiveness of the next generation of treatments for use on the NHS. We would like to see a clinical trial being made available for every cancer patient who would like to participate in one. That requires both investment in recovery of clinical research post Covid-19, to get us back to where we were before the pandemic, and broader measures to widen access to trials by reshaping funding, regulation, information and treatment pathways.”
18th June 2021
The drugs, known as POLQ inhibitors, specifically kill cancer cells with mutations in the BRCA genes while leaving healthy cells unharmed.
And crucially, they can kill cancer cells that have become resistant to PARP inhibitors – an existing treatment for patients with BRCA mutations.
Researchers are already planning to test the new drug class in upcoming clinical trials. If the trials are successful, POLQ inhibitors could enter the clinic as a new approach to treating a range of cancers with BRCA mutations, such as breast, ovarian, pancreatic and prostate cancer.
Scientists at The Institute of Cancer Research, London, and the pharmaceutical company Artios, explored the potential of using POLQ inhibitors in treating cancer cells with defects in the BRCA genes.
Their study, published in Nature Communications, was funded by Artios, Cancer Research UK and Breast Cancer Now.
For some time now, scientists have known that genetically removing a protein known as POLQ killed cells with BRCA gene defects, although drugs that prevent POLQ from working had not been identified. In this new work, the researchers identified prototype drugs that not only stop POLQ from working, but which also kill cancer cells with BRCA gene mutations.
Both BRCA genes and POLQ are involved in repairing DNA. Cancer cells can survive without one or other of them, but if both are blocked or their genes switched off, cancer cells can no longer repair their DNA and they die.
Researchers found that when cells were treated with POLQ inhibitors, cancer cells with BRCA gene mutations were stripped of their ability to repair their DNA and died, but normal cells did not. By killing cancer cells with BRCA gene mutations, while leaving normal cells unharmed, POLQ inhibitors could offer a treatment for cancer with relatively few side effects.
Researchers also found that POLQ inhibitors work very well when used together in combination with PARP inhibitors.
The addition of POLQ inhibitors meant that PARP inhibitors were effective when used at a lower dose. And in laboratory tests in rats and in organoids – three-dimensional mini-tumours grown in the lab – POLQ inhibitors were able to shrink BRCA-mutant cancers that had stopped responding to PARP inhibitors because of a defect in a set of genes known as the ‘Shieldins’.
This suggests that POLQ inhibitors could offer an alternative treatment where PARP inhibitors are no longer working. Researchers believe that using a POLQ inhibitor in combination with a PARP inhibitor in patients with cancers that have faulty BRCA genes could prevent resistance from emerging in the first place.
Scientists at The Institute of Cancer Research (ICR), funded by Breast Cancer Now and Cancer Research UK, discovered how to genetically target PARP inhibitors against BRCA-mutant cancers and, with colleagues at The Royal Marsden NHS Foundation Trust, helped run clinical trials leading to the first PARP inhibitor being approved for use.
The next step will now be to test POLQ inhibitors in clinical trials led by Artios.
Study co-leader, Professor Chris Lord, Professor of Cancer Genomics at The Institute of Cancer Research, London, and Deputy Director of the Breast Cancer Now Toby Robins Research Centre at the ICR, said: “All cells have to be able to repair damage to their DNA to stay healthy – otherwise mutations build up and eventually kill them. We have identified a new class of precision medicine that strips cancers of their ability to repair their DNA. This new type of treatment has the potential to be effective against cancers which already have weaknesses in their ability to repair their DNA, through defects in their BRCA genes. And excitingly, the new drugs also seem to work against cancer cells that have stopped responding to an existing treatment called PARP inhibitors – potentially opening up a new way of overcoming drug resistance. I’m very keen to see how they perform in clinical trials.”
Professor Paul Workman, Chief Executive of The Institute of Cancer Research, London, said: “It’s exciting that the new POLQ inhibitors should provide a different approach to treating cancers with BRCA gene defects – and particularly that this class of drugs should retain their activity in cancers that have developed resistance to PARP inhibitors. Most exciting of all is the potential of combining POLQ and PARP inhibitor drugs to prevent the evolution of BRCA-mutant cancers into more aggressive, drug-resistant forms – a major challenge that we see in the clinic.”
Study Co-Leader, Dr Graeme Smith, Chief Scientific Officer at Artios Pharma, Cambridge, said: “These exciting preclinical results provide a clear rationale for future clinical studies with a POLQ inhibitor. At Artios, we are on track to initiate our POLQ clinical programme before the year end to explore POLQ inhibition in the sensitive cancer types that this study has uncovered. Our planned POLQ inhibitor clinical studies will leverage these results, exploring combination treatment with PARP inhibitors and different types of DNA damaging agents.”
Zatreanu D et al. Polθ inhibitors elicit BRCA-gene synthetic lethality and target PARP inhibitor resistance. Nat Commun 2021;12:3636