Cancer Moonshot:
A story of hope for oncology in the US

The vision of ending cancer as we know it has long been a target for governments and politicians across the aisle. And there is a good reason why this particular disease unites competitors like few other public health initiatives. Cancer does not discriminate in who it impacts. Be it as a patient or supporting a loved one, the experience of cancer touches virtually everyone in one way or another.

As the second-leading cause of death in the US, it should come as no surprise that cancer has become a key talking point for many a political campaign debate, from President Richard Nixon’s ‘War on Cancer’ in the 1970s to President Bill Clinton’s championing of breast cancer efforts.

But in 2016, President Barack Obama sparked a new approach to accelerate cancer research and improve patient outcomes, promoting collaboration and uniting public and private organisations to pursue a noble goal.

This is the story of the Beau-Biden Cancer Moonshot.

2016
The cancer fight takes flight

Echoing President John F. Kennedy’s 1961 call for the nation to “commit itself to achieving the goal, before this decade is out, of landing a man on the moon and returning him safely to the Earth”, in January of 2016, then-US President Barack Obama announced an equally ambitious scientific goal during his final State of the Union address – to make a decade’s worth of advances in cancer prevention, diagnosis, and treatment, in five years.

Dubbed the Beau-Biden Cancer Moonshot programme, this national effort would see stakeholders, including the National Cancer Institute (NCI), the Department of Defense (DoD), and the private sector, harnessing the country’s vast scientific and technological capabilities to reduce the cancer death rate and change the experience of cancer for patients.

Leading the effort as what Obama called ‘mission control’, would be the then Vice-President, Joe Biden. It was no secret that Biden had a personal connection to cancer following the loss of his eldest son Beau to brain cancer at the age of 46. With Biden at the helm, the Cancer Moonshot Task Force was established to leverage federal investment, targeted incentives, private sector efforts, and patient engagement initiatives across the oncology spectrum.

One particularly influential act was the formation of a Blue Ribbon Panel (BRP), which was charged with outlining the state of the field across their topic areas, as well as identifying areas of scientific opportunity for the broader cancer community.

In September that year, the BRP presented its final recommendations to the National Cancer Advisory Board (NCAB). The ten recommendations were: establish a network for direct patient involvement, create a translational science network devoted exclusively to immunotherapy, develop ways to overcome cancer’s resistance to therapy, build a national cancer data ecosystem, intensify research on the major drives of childhood cancers, minimise cancer treatment’s debilitating side effects, expand the use of proven cancer prevention and early detection strategies, mine past patient data to predict future patient outcomes, develop a 3D cancer atlas, and develop new cancer technologies.

Moreover, in December, Congress passed the 21st Century Cures Act, which allocated $1.8 billion over seven years to help transition the Cancer Moonshot from ambition to reality.

2017
Laying the foundations for innovation

The arrival of a new Commander in Chief typically heralds a new array of goals that overshadow those of the outgoing party. However, the broad reach of cancer spanned the aisle, and the Moonshot received strong support from both Democrats and Republicans. While Obama and Biden continued their efforts outside the White House, newly appointed President Donald Trump vowed to pursue a cure for cancer while in office.

In the first full year of the five-year plan, the achievements seen in 2017 showcased the potential of a united public-private front as swathes of scientists, advocates, charities, and invested parties pooled their resources. One such effort was a collaboration between the National Institutes of Health and 12 leading biopharmaceutical companies, known as the Partnership for Accelerating Cancer Therapies (PACT). The $215 million project focused on efforts to identify, develop, and validate robust biomarkers to advance new therapies and treatments that harness the immune system to attack cancer.

Under the Moonshot, the National Cancer Institute introduced a new drug formulary. A public/private partnership between the NCI, pharma, and biotech companies, the formulary provides NCI-designated cancer centres and their investigators’ rapid access to agents for cancer trial use and pre-clinical research.

Alongside this formulary, 2017 saw the establishment of the FDA Oncology Center of Excellence. Initially authorised by the 21st Century Cures Act of 2016, the centre brought together regulatory scientists and reviewers with expertise in drugs, biologics, devices, and data science to support an integrated approach to evaluating products for the diagnosis and treatment of cancer. At the core of this mission was the aim to achieve patient-centred regulatory decision-making through innovation and collaboration.

Since its inception, the centre has launched several initiatives to champion patient-focused drug development, including Project Optimus, an initiative to reform the dose optimisation and dose selection paradigm in oncology drug development, and Project Confirm, designed to promote the transparency of outcomes related to accelerated approval for oncology indications.

2018/19
Giant leaps for mankind

Continuing the trend of innovation and progress set in 2017, 2018 proved to be a transformative year for oncology in the US as the Cancer Moonshot Initiative achieved several milestones that advanced cancer research and treatment.

One such accomplishment was the establishment of the Immuno-Oncology Translational Network (IOTN), created in response to the BRP’s recommendation to create a translational science network to advance immunotherapy for adult cancer patients. Comprised of multidisciplinary researchers, the IOTN aimed to improve immunotherapy outcomes and develop immune-based approaches to prevent cancers before they occur. The IOTN now consists of 32 academic institutions across the USA.

Another significant development was the launch of the Cancer Research Data Commons (CRDC), a centralised repository for cancer research data. While CDRC formed just one piece of Moonshot’s broader Cancer Data Ecosystem, the platform quickly became a robust resource through which researchers could access and share data and insights across long distances, accelerating the pace of cancer research.

On the subject of community resource efforts, a core feature of several Moonshot efforts is the idea that shared resources will be used to rapidly accelerate progress for patients. One notable example is the Human Tumor Atlas Network (HTAN), launched in late 2018. Funded by the NCI, the HTAN set out to construct 3D ‘atlases’ of the cellular, morphological, and molecular features of human cancers. Spanning a diverse range of cancer types as they progress from precancerous lesions to advanced disease, these atlases aid researchers in identifying the molecular and cellular conditions that cause healthy cells to become cancerous and drive critical transitions in advanced cancers.

Additionally, in 2018, the Cancer Moonshot Initiative supported the launch of NCI-CONNECT, a program aimed at advancing the understanding of rare adult central nervous system (CNS) cancers. NCI-CONNECT utilised the successful infrastructure and network of the Brain Tumor Trials Collaborative (BTTC) for clinical trials. The programme fostered partnerships and networks between patients, advocates, and providers to improve approaches to care and treatment for rare CNS cancers.

Primarily, this was a ground-breaking year in terms of treatment. The FDA approved two new immunotherapy treatments for cancer: pembrolizumab (Keytruda) and nivolumab (Opdivo). These treatments are based on the body’s immune system and have been shown to be effective in treating various cancers, including melanoma, lung cancer, and kidney cancer. Moreover, researchers at the University of Texas MD Anderson Cancer Center developed a revolutionary new type of immunotherapy treatment – CAR-T cell therapy.

2020/21
COVID-19 and cancer research

Understandably, the unexpected arrival of COVID-19 threw something of a wrench into the five-year targets for Moonshot. However, despite the challenges and limitations resulting from social distancing and lockdown mandates, the mission endured. Recognising the impact that the pandemic had on cancer patients and research, efforts were made to understand the intersection between the two diseases, including the impact on cancer treatments, clinical trials, and patient outcomes, and to mitigate the effects of the pandemic on cancer care across the nation.

In 2020, investigator groups from the HTAN made significant progress in advancing our understanding of how cancers develop and respond to treatment. One such team developed a profiling ‘toolbox’ for capturing the complex molecular characteristics of fresh and frozen tumour samples.

Elsewhere researchers from the PDX (patient-derived xenografts) Development and Trial Centers Research Network (PDXNet), a coordinated research programme tasked with the large-scale development and pre-clinical testing of targeted therapeutic agents in patient-derived models, demonstrated the reproducibility of PDX drug responses and sequencing results across diverse experimental protocols, which established the potential for multisite pre-clinical studies to translate into clinical trials.

In January, the nation welcomed President Biden as he began his first term at the helm of the US Government. Unfortunately, while he reaffirmed his commitment to eradicating cancer, Biden’s return – five years on from the launch of the Beau-Biden Cancer Moonshot – was not accompanied by news that the programme had achieved its ambitious goal. But, if at first, you don’t succeed…

2022/23
To infinity and beyond

Unperturbed by the five-year milestone, President Biden announced Moonshot 2.0, a new front in the war on cancer as part of World Cancer Day, setting a new –equally ambitious – goal of reducing the cancer death rate by 50% within 25 years.

As part of Moonshot 2.0, the President convened the inaugural Cancer Cabinet to establish a prioritised agenda and appointed three distinguished members of the scientific, research, and public health communities, Dr Mitchel Berger, Dr Carol Brown, and Dr Elizabeth Jaffee, to serve on the advisory President’s Cancer Panel.

Just as the BRP had done years earlier, the Cancer Cabinet identified and released priority actions to guide agencies toward realising the vision of “ending cancer as we know it”. These included: closing the screening gap, understanding and addressing environmental and toxic exposures, decreasing the impact of preventable cancers, bringing cutting-edge research through the pipeline to patients and communities, and supporting patients and caregivers.

One year on, in 2023, the Cancer Moonshot had announced over 25 new programmes, policies, and resources to address these five priority areas. On the first anniversary of Moonshot 2.0, the Biden-⁠Harris Administration announced the NCI’s launch of a first-of-its-kind, public-private partnership to bring clinical and patient navigation support to families facing childhood cancer. The administration also unveiled the launch of CancerX, a public-private partnership developed as a national accelerator to boost innovation in the fight against cancer and revealed that the Health Resources and Services Administration (HRSA) planned to award $10 million to improve access to lifesaving cancer screenings and early detection including patient navigation support services, expanding on the $5 million awarded to 11 health centres in 2022.

With approximately $1.8 billion requested in the President’s FY 2024 Budget for strategic investments in the Cancer Moonshot initiative, it is evident that the Biden-Harris Administration has high ambitions to advance the cancer effort in the US. However, with just over a year left in his first term, researchers, stakeholders, and patients will have to wait and see whether the next administration will continue the momentum of Cancer Moonshot in 2024 and beyond.

Eloise McLennan is the editor for pharmaphorum’s Deep Dive magazine. She has been a journalist and editor in the healthcare field for more than five years and has worked at several leading publications in the UK.

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Cancer Moonshot: A story of hope for oncology in the US

2016 The cancer fight takes flight

2017 Laying the foundations for innovation

2018/19 Giant leaps for mankind