Accelerate Cures Through International Collaboration In Clinical Trials: Cancer Moonshot Pathways

Note: President Joe Biden in February launched a “Cancer Moonshot” initiative that aims to reduce the death rate from cancer by 50% in the next 25 years. This is a part of a series of posts with cancer experts offering suggestions to help the Moonshot succeed. The upcoming 3^rd Forbes China Healthcare Summit” on August 27 (August 26 ET) will address “New International Directions For A Reignited Moonshot” as its main theme this year. Registration is free. For more information, contact: [email protected]. The following post offers written suggestions from Nancy Y. Lee, MD, Lisa M. DeAngelis, MD and Bob T. Li, MD from the Memorial Sloan Kettering Cancer Center (MSK) in New York.

In 2016, then Vice President Joe Biden launched the Cancer Moonshot initiative with the goal to accelerate progress in the fight against cancer. As a result, the academic research, industry, and patient advocacy communities joined forces with tremendous energy and enthusiasm toward a common purpose.

This year, President Biden renewed his dedication to combat this disease and is on the quest to end cancer by setting the goal of reducing the death rate from cancer by at least 50% in the next 25 years. The President also announced the need to improve the quality of life of patients living with cancer, invest in screening and early detection, address inequities of access to care and improve the diversity of participants in clinical trials – the critical step of translating scientific discovery to saving lives.

However, the Cancer Moonshot has largely been a United States domestic initiative with relatively few efforts on international collaboration, though cancer remains a global killer that takes 10 million lives worldwide every year with devastating effects on their families. As the world enters a post-pandemic era marked by technological transformation and connectivity, the mission to eliminate cancer as a major cause of death has now become achievable within a lifetime by leveraging international collaboration on clinical trials.

The COVID-19 pandemic has upended worldwide healthcare systems and exposed inefficiencies and vulnerabilities in our traditional model restricted to hospital-centric in-person cancer care. Clinical trials may now leverage remote consent and telemedicine technologies to improve enrollment and treatment monitoring, making clinical trials more patient-centric and potentially more accessible in rural and underserved communities.

International multiregional clinical trials expand the diversity of participants and may accelerate the timeline to regulatory approval by many years. The United States Food and Drug Administration (FDA) approval of the first KRAS inhibitor sotorasib was a watershed moment in oncology, as this was the first breakthrough in four decades since the discovery of KRAS, the most commonly mutated oncogene in human cancers.

What is not commonly appreciated is the fact that this breakthrough was delivered in record speed of less than three years (compared to the typical 10-15 years drug development timeline) and conducted largely during the COVID-19 pandemic when clinical trials were typically shut down. The CodeBreaK100 clinical trial utilized remote monitoring technologies and international collaboration between eight countries across North America, Asia and Europe to enable remote drug shipment, telemedicine and continued patient accrual to deliver this historic breakthrough. Through Project Orbis, an FDA Oncology Center of Excellence led collaborative initiative of international regulatory harmonization between government agencies, sotorasib was rapidly approved in multiple countries outside of the United States, including Canada, Australia, Japan, Switzerland and the U.K., thus speeding the delivery of innovative and lifesaving medicines to more patients. We can now use this achievement as a model for international clinical trials in the post-pandemic era, leveraging technology and collaboration to accelerate many more breakthroughs at unprecedented speed and scale.

Accelerating approval for a new treatment approach may not always involve a novel drug. NRG Oncology HN001 is a phase III international randomized trial aimed to personalize systemic therapy for locoregionally advanced nasopharyngeal cancer based on a novel blood-based biomarker, plasma Epstein-Barr Virus DNA, otherwise known as a liquid biopsy. As nasopharyngeal cancers are significantly more prevalent in Southern China and Southeast Asia, it was important to open trial sites in the Asia-Pacific region. Although this U.S. led trial was launched in May 2014, first patient enrolment from Asia did not occur until years later. Significant differences in regulatory oversight from various countries resulted in approval delays, denying access of the trial to some of the most needy and scientifically important patient populations. The time, effort, and cost spent on regulatory oversight were prohibitive especially given the novelty of the liquid biopsy biomarker.

Drawing from this experience and lessons learned from COVID-19, we imagine a new post-pandemic paradigm where regulatory standards around the world may be harmonized with digital technology to increase efficiency of clinical trial activation and enrollment. Novel technologies such as liquid biopsy are constantly evolving, and these advances are now heralding potential blood tests for early cancer detection but with increased regulatory complexities in assessing their accuracy and utility. To achieve this goal of international regulatory harmonization, multistakeholder collaboration among government, industry, academia, patient advocacy and media is critical, and this is where Cancer Moonshot may play an important leadership role in breaking down silos and bringing the world together. These efforts will ultimately improve the standard of care for patients not only in the U.S. but also around the world.

In summary, we are committed at MSK to accelerate breakthroughs by leveraging novel technological advances and collaboration in international clinical trials. As President Biden reignites Cancer Moonshot, we argue that cancer is not just an enemy of Americans, but the whole of humanity, thus presenting a unique opportunity for American global leadership. We cannot fight cancer alone, but by bringing the world together through an international moonshot, we can realistically end cancer as we know it, in this lifetime together.

—Nancy Y. Lee, MD, FASTRO, is a radiation oncologist, Chief of Head & Neck Radiation Oncology, Chief of Proton Therapy Service, and Vice Chair, Department of Radiation Oncology at Memorial Sloan Kettering Cancer Center

—Lisa DeAngelis, MD, is a neuro-oncologist, Physician-in-Chief and Chief Medical Officer; and Scott M. and Lisa G. Stuart Chair at Memorial Sloan Kettering Cancer Center

—Bob T. Li, MD, PhD, MPH, is a medical oncologist, Physician Ambassador to China and Asia-Pacific; and Chief Scientific Officer, MSK Direct at Memorial Sloan Kettering Cancer Center

See related posts:

Meet The Scientist Coordinating Joe Biden’s New Cancer Moonshot

“Why Is Cancer Less Important To Cure Faster Than Covid?”: Cancer Moonshot Pathways

Incentivize The Fight Against Cancer That Affects Kids: Cancer Moonshot Pathways

Breakthrough Barriers To Drive Progress: Cancer Moonshot Pathways

Biden Deserves Credit For Taking On Cancer: Cancer Moonshot Pathways

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