Oncology research in the age of COVID-19

pharmafile | September 14, 2020 | Feature | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing |  CAR T, CAR-T, Cancer, feature, pharma 

Matt Fellows investigates the new challenges facing the oncology space and explores the strategies that can carry it through the disruptive COVID-19 pandemic.

Pandemic or not, the treatment of cancer presents one the greatest challenges of any therapeutic area to research institutions, healthcare systems, and the life sciences industry. The coronavirus outbreak earlier this year has compounded old challenges and given life to entirely new ones in the research and treatment of cancer, requiring new solutions. The UK has been one of the worst-hit nations on earth, straining an already overstretched NHS to absolute breaking point.

To rise to the challenge, it is important to recognise the extent of the damage that has been done. To get a picture of how research operations have been affected in the UK and around the world, Pharmafocus spoke to Professor Clare Turnbull, Professor of Cancer Genomics at The Institute of Cancer Research (ICR) in London.

“COVID-19 has had a devastating impact on the delivery of cancer services. The pandemic has put enormous pressure on the NHS at every stage of the cancer pathway and some of our recent research has helped stimulate a national conversation about an imminent ‘cancer crisis’,” she explained. “By modelling the likely effect of pausing or cancelling urgent cancer referrals and surgery as a result of COVID-19, the work we have carried out at the ICR suggests that resulting delays to cancer treatment will potentially lead to many thousands of attributable cancer deaths.

“Our own research to develop new treatments for cancer patients was also paused during lockdown, with the majority of ICR laboratories having to close temporarily to ensure the safety of staff,” she continued. “In the current landscape, cancer patients are more vulnerable than ever, and this adds urgency to our need to design smarter, kinder and more effective cancer treatments. For this reason, the ICR has launched a major fundraising appeal to kick-start our work and make up for the many vital research hours lost to the COVID-19 crisis.”

The pandemic has also dealt a devastating blow to the delivery of cancer services in the UK. There reasons are many, from services and facilities having to be shut down or run at reduced capacity due to the risk of spreading COVID-19, to the reluctance of patients to visit hospitals or diagnostic centres for fear of catching the virus, or for not wanting to add weight to an already overburdened heath service.

By the beginning of June, there were 290 million fewer urgent referrals made for further testing compared to pre-pandemic levels, and the backlog of people waiting for cancer screening, tests or treatments in the UK had broken two million.

DATA-CAN: The Health Data Research Hub for Cancer, a partnership of NHS organisations, patients, charities, academia and the life sciences industry, leverages data with the goal of developing improved cancer therapies with faster access to clinical trials and has been monitoring the impact of COVID-19 on cancer services in the UK. Pharmafocus spoke to Dr Charlie Davie, Director of DATA-CAN, to learn more about what was discovered.

“The UK’s national cancer strategies are focussed on detecting cancer at an earlier stage when it is easier to treat, as the UK has later diagnoses and poorer cancer outcomes than other comparable countries,” explained Dr Davie. “The COVID-19 emergency has clearly had an adverse impact both on patients choosing to access healthcare when they have worrying early symptoms that could be cancer, and with the NHS’s capacity to refer individuals with a suspicion of cancer and treat patients with a confirmed diagnosis.”

In partnership with The UCL Institute of Health Informatics, DATA-CAN utilised near real-time data from UK hospital trusts in March and April and found that there had been an average decrease of 71% in urgent referrals and an average 60% decrease in chemotherapy attendances. DATA-CAN then took this methodology and applied it to the bigger picture of cancer patient outcomes, and came to a grim conclusion, as Dr Davie noted:

“Applying this near real-time data in a modelling approach to data from a cohort of over 3.8 million patients in England, with linked primary and secondary care data, suggests that the COVID-19 emergency in England could result in at least 20% (6,270) more deaths over the next 12 months in people who have been newly diagnosed with cancer. This figure could rise to 17,915 additional deaths, if all people currently living with cancer are considered.”

He added: “This pre-published data was shared with the chief medical officers of the four nations of the United Kingdom and with the National Clinical Director for Cancer for England, contributing to the decision to restart cancer services.”

Bridging research and treatment

It goes without saying that these projections within cancer services are nothing short of a tragedy if they come to pass, but they don’t exist in a vacuum; the delivery of effective therapies to improve outcomes for cancer patients is dependent on an intricate and interrelated network of institutions and services. So why is awareness of the cancer service landscape key knowledge for the life sciences industry?  Dr Davie explains:

“The UK’s life sciences industry needs to know how cancer services are being modified and evolving during the pandemic, so that they can understand and respond to challenges such as changes in demand for medicines. This question is at the heart of how innovation can be taken from bench to bedside, moving from research discovery to patient recovery. Evidence is available that demonstrates that those patients who are treated in research-active hospitals have better outcomes. Therefore, we need a clearer understanding and greater connectivity between R&D and treatment delivery, in order to ensure that promising discoveries are translated to clinically focused innovation for patients.

“Those working in R&D need to have a clear understanding of the clinical challenges and bottlenecks and healthcare systems need an understanding of the science and what it can realistically achieve,” he continued. “While it is clear that these two domains should be inextricably linked, unfortunately this is not always the case. In the UK, we are in a great position to bring together these different communities for added value and patient impact.”

And the key to making it happen in these demanding times? Data, says Dr Davie.

 “DATA-CAN works with academics, the health service, and companies to ensure that patients benefit from the latest insights that data can bring, ensuring that data are deployed responsibly and effectively within a trusted research environment in an approach that promotes fair value for all stakeholders. 

“The result of using data and fostering greater cooperation between R&D, clinical services and the life science industry is that we are able to better target which patients are suitable for clinical trials and offer a wider amount of research opportunities for patients. This is a double win – it is good news for patients who can access trials and good for UK plc, bringing in more investment.”

Trials and tribulations

The sad truth is that strategies like this which can galvanise oncology clinical studies are desperately needed right now. Since the upturning of the world earlier this year, industry has been forced to either refocus its limited resources or halt operations altogether.

“In parallel to the decreases in cancer care demand and capacity, there has been a significant reduction in clinical trial capacity and activity as hospitals, cancer researchers and research infrastructure have refocused on COVID-19,” explained Dr Davie. “Clinical trials have been delayed and most laboratory-based research has been interrupted.”

According to Mohamed Abukar, Clinical Trials Analyst at analytics firm GlobalData, “Clinical research disruptions involving experimental cancer therapeutics raise severe challenges, as these trials can be highly time-sensitive and even small administrative delays can prove highly detrimental to patient populations.”

According to findings from GlobalData, head and neck, colorectal, and non-small cell lung cancer were among the most highly disrupted oncology trial areas, accounting for 10.8%, 11.7% and 13.3% of all interrupted studies. Worryingly, breast cancer – the most common form of cancer in women and the second most common overall – was the second most disrupted area at 15.1%. Solid tumour research was the most highly disrupted, accounting for one in five of all halted oncology trials. However, as research operations begin to fire back up, solid tumour studies have accounted for the largest proportion of resumed trials at 18.8%.

Dr Davie continued: “The suspension of cancer trials will clearly have an impact on patients and the research community and could delay the discovery of new treatment options. The fundraising impact upon cancer charities has also been significant, with Cancer Research UK reducing research spend by at least £150 million over the next five years.”

An unfortunate but illuminating example, Cancer Research UK has been a casualty of COVID-19’s impact, announcing in July that it would be cutting its workforce by almost a quarter to steel against an anticipated loss of income of £160 million this financial year, and £300 million over the next three years. Incidences likes this only further imperil the future recovery of a sector already knocked off guard. 

However, as devastating as the outbreak’s initial impact was and has been, we are beginning to see some semblance of normality returning to research operations in the life sciences industry. It’s a positive picture and there are reasons for optimism; recent research from GlobalData indicated that, in August, clinical trial disruption had hit a three-month low, with 37.8% of halted studies having resumed. 

“Despite a high number of COVID-19 cases worldwide, organisations conducting clinical trials are increasingly becoming able to overcome safety and enrolment challenges by adapting and putting the necessary practices into place to effectively conduct clinical trials,” noted  Abukar. “Modifications such as reducing hospital visits to minimise risks, especially when therapies that have immunosuppressive effects, will help keep trials open.”

So clinical trial operations are slowly opening up again, but what strategies are the pharma industry leaning on to make this happen? Pharmafocus caught up with Mari Scheiffele, General Manager UK & Ireland at Novartis Oncology, to find out how the company has weathered the storm and pushed through the disruption.

“With the support of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), we’ve developed innovative ways to continue many of our existing clinical trials, including creating secure online systems that allow our Clinical Research Associates to work remotely,” she explained. “We have also partnered closely with NHS trusts and healthcare professionals to establish processes for activities like remote follow-ups, which ensure the most at-risk patients can still safely participate in clinical trials.

“We have also benefited from coordination across the different UK healthcare agencies. When Novartis identified the potential for one of its cancer medicines, ruxolitinib, to treat COVID-19-related pneumonia, the efficient collaboration between the MHRA, the UK Ethics Committee, the NHS, the NIHR and the hospitals enabled a clinical trial to start in an unprecedented three weeks. For a process with an average time to approval of 12 weeks, the UK was the first country, globally, to achieve first patient first visit and first patient first treatment milestones for the Phase 3 RUXCOVID trial. The learnings from this record success will be key for future trials.”

So, from the darkness, we can finally see the dawn rising in the field of oncology research. The pandemic is far from over and there will be many more challenges in the year ahead, but the fact that clinical research is gathering steam after such an abrupt halt is reassuring. But resources and time are still at a premium, and careful, methodical and evidence-based approaches which leverage valuable data could vastly improve efficiency and efficacy where it really matters and make those limited resources stretch further. And this could prove to be a life-saving effort. 

“Over the coming months, DATA-CAN is developing its near real-time data network by collaborating with cancer centres in NHS trusts across the UK to complement the longer term and highly curated existing national data sets and services,” explained Dr Davie. “This will allow collaboration between researchers to bring timely insights from the analysis of the immediate and raw data from NHS cancer services and ultimately deliver value back to the NHS to inform service delivery and enhancement. It also represents an opportunity for life sciences companies to engage with patient-approved data access and services in a way that returns value to the NHS and to academic research.”

From the viewpoint of the pharma industry, Scheiffele calls for a shot in the arm to the operation of clinical trials through further investment in research, while collaboration will be crucial.

“We believe that to harness the UK’s existing R&D strengths and to maximise the benefits this sector can bring for patients, we must increase investment in clinical research, simplify the process for setting up and running clinical trials, and harness the UK’s data infrastructure in our R&D efforts, ensuring the patient perspective is reflected throughout this process,” she remarked. “In addition, only by working with our partners to implement the advancements in remote care across the patient pathway – from faster diagnosis and screening to increased treatment access and patient engagement in care – will we be able to see a long term impact on cancer patient outcomes.

“The collaboration and partnership shown across all UK healthcare stakeholders during this time has demonstrated what can be achieved. It is therefore paramount that we continue to work together, identifying what has worked well, and drive further positive change so we can, together, transform cancer treatment and improve outcomes for cancer patients in the UK.”