Open Access Government spoke to the National Cancer Institute’s Dr S Percy Ivy about cancer research and training and the importance of clinical trials
The National Cancer Institute (NCI) is one of 27 institutes that make up the National Institutes of Health (NIH). The NCI is the US federal government’s primary agency for cancer research and training, and coordinates with the National Cancer Program, which supports research, training, health information dissemination, and other programmes with respect to the cause.
Cancer is a term that everyone worldwide is aware of, with new research suggesting that 1 in 2 people will be diagnosed with cancer in their lifetime. The NCI estimated that 1,685,210 new cases of cancer would be diagnosed in the US in 2016 and that 595,690 people would die from the disease. However, the number of people living beyond cancer diagnosis reached nearly 14.5 million in 2014 and is expected to rise to almost 19 million by 2024.
Research is an integral (but not the only) part of the work conducted at the NCI. Research helps to learn more about various forms of cancer and how to treat and prevent the disease. Clinical trials are research that involves people, in order to help find to find new ways to improve treatments and the quality of life for people living with the disease.
Open Access Government Editor Laura Evans speaks to Dr S Percy Ivy at the NCI about the role of clinical trials and how cancer research has evolved over the years.
“Cancer clinical trials are essential for advancing the treatment of patients. These trials are a controlled framework in which selected populations of patients with cancer can be treated in a clinical research setting, based on results of earlier studies,” explains Dr Ivy. “Essentially, for patients the goal is to prolong their life and, hopefully, be cured of the disease.
“The trial accomplishes several objectives from a medical and scientific point of view; we hope it changes the standard of care and improves the care and management of cancer patients. Patients are looking for response, slowing of their disease and improvement in their overall quality of life, and in some instances even remission and cure.
“I believe that clinical trials are essential for the advancement of cancer treatment. Networks of clinical investigators allow clinical researchers to evaluate large cohorts of patients, and more efficiently evaluate new treatments together across the country,” Dr Ivy adds.
Developing new cancer treatments
The Cancer Therapy Evaluation Program is one of the many programmes within the NCI and is focused on developing new cancer treatments. The clinical trials are made up of different phases which are used to detect how cancer responds to specific treatments.
As Dr Ivy outlines further: “Within the Cancer Therapy Evaluation Program there are two very large programmes. The first is the Experimental Therapeutics Clinical Trials Network, made up of academic investigators across the US and Canada, who perform early phase clinical trials. The goal of those trials is to determine how to use a drug, what the drug properties are, and how it should be used in humans, as well as developing preliminary information on how the cancer responds to specific therapeutic interventions.
“The other large group in the US is the National Clinical Trials Network,” she adds. “This is a group of more than 3,000 investigators who perform much larger randomised phase 2 and phase 3 trials. They are looking for signs of activity, efficacy and survival or response to a treatment or combination treatment that will lead to a pivotal trial. The goal is to move to phase 3 trials that may result in licensing the treatment for a specific disease indication.”
Orphan diseases and rare types of cancer
The NCI is aiming to find treatments for all types of cancer; however, they also focus on rare forms of the disease besides what are known as the big four – colon cancer, breast cancer, lung cancer and prostate cancer. The rare forms are ones that are not as actively studied or used in clinical trials by pharmaceutical companies and have less than 200,000 cases per year, although this landscape is changing.
“Orphan diseases, are defined as affecting fewer than 200,000 cases a year, and have not been as actively studied,” says Dr Ivy. “In the past these orphan cancers have been much less attractive targets for pharmaceutical companies, so the NCI has filled this niche as an unmet medical need. Pharma is also changing and starting to work more in niche diseases. As we find that cancers, for example breast cancer, are really made up of a group of biologically distinct diseases that require different treatments, the challenge is to provide effective treatments for all different kinds of cancer and the challenge for pharma is to define a sustainable niche market.
“The goal of the NCI is to provide those treatment opportunities to the US public. The US Congress recently passed a bill called the ‘21st Century Cures Act’ that will fund $4.8bn in medical research with approximately $1.8bn cancer related research. This means that we are able to develop synergies between programmes and initiatives that can effectively use that money in service of the public. We will do that collaboratively with researchers, organisations and companies and with our academic co- investigators, with the primary goal to make treatment for cancer widely available and accessible no matter how rare your disease is.”
A revolution in cancer research and training
As our knowledge of cancer evolves, new ways to treat the disease are also established. Along with new technology and key innovations, research and clinical trials are able to understand the best treatment for a specific type of cancer. Dr Ivy explains that cancer research is in the middle of a revolution, with new therapies such as precision medicine and immunotherapy coming to the forefront.
“With the exception of immunohistochemistry for PDL1, there are no biomarkers to select patients to receive anti PD-1/PDL-1 immunotherapy,” she says. “The tumours that have responded to these so-called checkpoint inhibitors have been those that were treated in the past with other immunotherapy agents, especially melanoma and renal cell carcinoma.
“However, there are areas in immunotherapy treatment that clearly stand out for the favourable response rates that have been seen, including lung cancers and Hodgkin’s lymphoma, as well as some rare diseases, such as Merkel cell tumours. However, the utility of the PD-1 biomarker to identify patients who are likely to respond is limited, and more work is needed to develop more robust biomarkers. What is becoming very clear with immunotherapy, as is the case for most effective cancer treatments, is that it needs to be combined with other therapies, including chemotherapy, molecular therapies and radiation therapy.
“Cancer treatment globally will be changing. In addition to the scientific challenges, the high cost of treating cancer patients with immunotherapies and other therapies remains an issue. We must ensure that academic clinical research in the public interest is available widely and not simply to those who can afford it.”
Dr S Percy Ivy
Program Director, NCI Experimental Therapeutics Clinical Trials Network (ETCTN)