In a first-of-its-kind collaboration, Memorial Sloan Kettering joined forces with the Chinese Thoracic Oncology Group (CTONG) — an alliance of more than 30 premier academic cancer centers in China — in an effort to establish a program of clinical trials that are open to patients from both the United States and China. The initiative focuses initially on clinical trials of precision cancer therapies for lung cancer, the number-one cause of cancer deaths in both nations.
The collaboration, formalized in December 2018, is designed to build the academic foundation for multicenter US-China clinical trials, with the ultimate goal of boosting enrollment in clinical trials so that effective new therapies can be developed and approved faster for patients in need. Other distinctive aspects of the partnership include virtual educational initiatives to improve patient care in both countries as well as efforts to foster industry and government regulatory agency participation. For help in navigating this new terrain, MSK and CTONG have engaged regulators from the US Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA), as well as leaders from the Clinical Oncology Society of Australasia (COSA), Thoracic Oncology Group of Australasia (TOGA) and the New York–based Asia Society Policy Institute (ASPI) for policy advisory support.
“While COVID-19 has changed the world, it will not stop the need to find a cure for cancer,” said MSK Physician-In-Chief Lisa DeAngelis at the virtual Symposium. “Clinical trials generate new knowledge and transform patient care. The MSK-CTONG collaboration is a platform for the international exchange of ideas that will lead to innovative science.”
“MSK’s mission of curing cancer is international. Although we are making great strides in the treatment of lung cancer, we must do more to advance care for people on a global scale,” said Sir Murray Brennan, Senior Vice President of International Programs at MSK. “This unique partnership gives us an opportunity to speed up the approval process for lifesaving therapies with benefits that may have ripple effects worldwide. MSK is particularly grateful to Dr. Yi-Long Wu and CTONG’s friendship, as demonstrated by the countless number of shipments of masks and PPE donated to MSK in 2020 during the peak of our COVID-19 crisis in New York City.”
“Over the past three years MSK and CTONG have worked hand in hand to be a model for international collaboration and worked hard towards the ultimate goal of joint clinical trials,” remarked surgical oncologist Yi-Long Wu, President of CTONG and Lifetime Director and former Vice President of Guangdong Provincial People’s Hospital, in Guangzhou, China. “More than 750,000 people are diagnosed with lung cancer every year in China, with a similarly high death toll. The strong partnership with MSK, along with guidance of the regulators and policy advisors, helps accelerate the development of new therapies and prevention strategies against a common enemy.”
A Collaboration Enabled by a New Regulatory Environment in China
The MSK-CTONG collaboration came on the heels of regulatory changes instituted in China in 2018 to fast-track the availability of new drugs from the United States and elsewhere. Previously, the approval process for therapies already proven in clinical trials outside of China could take many years, often requiring Chinese clinicians to repeat entire trials in the Chinese population, thus delaying access to new medicines for Chinese patients.The new regulations allow for the use of clinical data from outside of China, helping shrink approval times to 60 days or less. The rules also open the door to having Chinese investigators participate in clinical research with American counterparts toward a common goal. For the first time, cancer physicians and scientists can work together to develop new therapies for potential simultaneous regulatory approvals in the US and China, consistent with the goal of Project Orbis as envisioned by Dr. Pazdur and Dr. de Claro at the Oncology Center of Excellence, US FDA.
“The new regulatory environment places China on the same footing as the rest of the world,” said Bob Li, a medical oncologist who specializes in lung cancer and MSK’s Physician Ambassador to China and Asia-Pacific. “For the first time, we can work together to develop new therapies for simultaneous regulatory approval in the US and China through multicenter clinical trials. This can be done at a much faster pace through the scale of China’s infrastructure and cancer population, for the benefit of the American and Chinese people. Project Orbis as led by Dr. Pazdur and Dr. de Claro of the FDA, is an example where international collaboration between government regulators of the US, China and the rest of the world to fight a common enemy is possible.”
The Honorable Kevin Rudd, Australia’s 26th Prime Minister and 8th President and CEO of the Asia Society, declared, “Cancer affects everyone. I commend each one of you for dedicating your expertise to this important mission. Women and men of intelligence, capacity and ethics such as those gathered in the symposium can make a real difference – not just in your field, but to cause a change in the way in which people view the future of the relationships of our countries in the long term as well.”Back to top
A Focus on Precision Medicine and Lung Cancer
Together, the United States and China account for more than half of the 2 million lung cancer diagnoses made worldwide each year. Precision medicine, an area of particular promise for lung cancer, is the scientific basis of the MSK-CTONG collaboration.
Precision cancer medicine, also called precision oncology, involves the development of drugs that target genetic or proteomic changes in cancer cells, the tumor microenvironment, or a patient’s own immune system. Such targeted therapies may provide more-effective control of the disease with fewer side effects than traditional drugs. However, there are challenges in developing such personalized approaches. One of those challenges concerns enrollment in clinical trials. In particular, it can take a long time to identify enough participants with a specific mutational profile so that a trial can move forward.
“MSK is a world leader in precision medicine,” remarked Dr. Li. “But we’re not always able to move things forward as quickly as we’d like. Considering China’s vast cancer population and the talent and dedication of their physicians, the MSK-CTONG collaboration will be able to accelerate the enrollment process, so that we can exponentially scale precision cancer research.”
“This is an area where China can benefit from MSK due to its global leadership in precision medicine and early-phase clinical trials,” says Dr. Wu. “China can contribute through the quality and size of CTONG to make the large-scale development of precision medicine possible in the US.”Back to top
Next Steps: Launch of The First US-China Clinical Trial is Only the Beginning
The groundwork for the first US-China multicenter clinical trial was laid in December 2018 when the multidisciplinary group of leaders from MSK, CTONG, the US FDA, China NMPA, ALTG/TOGA, and ASPI convened in New York for the first annual MSK-CTONG Symposium. Since then, both MSK and CTONG have worked tirelessly with industry collaborators, the FDA, and the NMPA to make this a reality. MSK and CTONG are now incredibly proud to announce that, with the guidance of these key stakeholders, and in collaboration with Roche/Genentech and the Thoracic Surgery Oncology Group (TSOG), that their first US-China multicenter clinical trial has been successfully launched in late 2020 (NCT04611776). Patients in the US and China are expected to begin enrolling in early 2021. Many more novel concepts were discussed at the symposium, with a view to converting them to international clinical trials.
With this momentous achievement in mind, Dr. Andrew Seidman, Medical Director of MSK’s Bobst International Center, and Dr. Bob Li concluded the symposium by laying out the next steps for further collaboration: “The launch of our first US-China joint clinical trial is a major milestone. Yet, it is just the first of many in our collaboration with CTONG. We hope to launch many more international clinical trials, including phase 1 trials, which translate laboratory science to patients in clinic, and open doors to scientific innovation in multiple cancer types. Phase 1 clinical trials require a lot of profiling of tumor, whether it is proteomics or genetics, so there is a lot of big data to be analyzed and shared. The regulatory framework behind sharing data will need to be spelled out in a stepwise manner. This touches upon Dr. Pazdur (US FDA)’s invitation to regulatory counterparts in China to work together on Project Orbis. Policy stakeholders such as Asia Society Policy Institute led by the Hon. Kevin Rudd are also helping to engage government leaders and form a policy framework to help bridge the regulatory gap between countries to accelerate cancer medicine development. We will all continue to work together toward a harmonized and transparent framework at the regulatory and clinical levels to quickly deliver better treatments to patients in the US, China, and the rest of the world.”Back to top