Valerie Rusch, Murray Brennan, Bob Li, Charles Rudin
Building on their long-term shared commitment to international collaboration on cancer research and care – Memorial Sloan Kettering Cancer Center (MSK) and the Chinese Thoracic Oncology Group (CTONG), an alliance of more than 30 premier academic cancer centers in China – joined forces earlier this month for the 4th Annual MSK-CTONG Symposium. The event co-hosted with Dr. Yi-Long Wu, President and Chairman of CTONG, brought together leading physician-scientists from the U.S. and China to discuss how best to collaborate on international clinical trials of new cancer therapies to help millions of patients worldwide.
Now in its fourth year, the initiative promotes international clinical trials of precision cancer therapies and patient care educational programs in these two countries, which enables greater access for American and Chinese patients to enroll in international clinical trials.
With support from regulators with the U.S. Food and Drug Administration (FDA), the China National Medical Products Administration (NMPA), leaders from the Asia Society, CEO Roundtable on Cancer, Shanghai TuoXin Health Promotion Center, Forbes China and Bloomberg New Economy, the collaboration is paving the way for faster approvals of new cancer therapies. The effort received warm congratulations and encouragement from the Honorable Kevin Rudd, President and CEO of Asia Society, and the 26th Prime Minister of Australia.
“Since its inception, the collaboration between MSK and CTONG has become part of a much larger international movement of scientists focused on curing cancer,” said Dr. Bob Li, a medical oncologist at MSK who specializes in lung cancer and serves as MSK’s Physician Ambassador to China and Asia-Pacific, during the Symposium. “This is a movement where everyone has an important role to play, and one that requires a multi-stakeholder effort to accelerate the development of innovative therapies and ensure they can be delivered quickly to patients around the world.”
Also during the Symposium, Sir Murray Brennan, Senior Vice President of International Programs at MSK, said: “On behalf of MSK, I would like to thank and acknowledge everyone who joined the Symposium for the incredible amount of work put into this event. This is the first of many such endeavors between scientists and clinical translational researchers that will make a meaningful difference in the lives of cancer patients in China and the U.S. This collaboration will enable us to expedite the approval process for new cancer therapies, thereby quickly translating scientific discovery into saving lives.”
Panel discussions at the Symposium covered several topics, including liquid biopsy and technology-guided trials, team-driven precision immuno-oncology trials, research and development of antibody-drug conjugates (ADCs), strategies to overcome immunotherapy resistance, and how to convert phase 1 clinical trials into international developments and approvals. These discussion points highlight the importance of international collaboration to advance clinical trials and groundbreaking cancer technology and research.
Creating Favorable Environments to Accelerate International Clinical Trials
Since 2018, the MSK-CTONG collaboration has expanded the availability of new drugs from the U.S. and other countries, as China made it easier for regulatory bodies to approve therapies for cancer patients in China.
This shift in China’s regulatory environment and CTONG’s collaboration with MSK have paved the way for simultaneous regulatory approvals of new therapies in the U.S. and China. This is consistent with the goal of Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE) which provides a framework for concurrent submission and review of oncology products among international partners. The initiative, led by Dr. Richard Pazdur, director of the OCE, with assistance from Dr. R. Angelo de Claro and Dr. Lola Fashoyin-Aje also from the OCE, was recognized by President Biden as a key component of the Cancer Moonshot program. The collaborative spirit of international regulatory harmonization behind Project Orbis was highly commended by Dr. Martin Murphy, the Co-Founder of CEO Roundtable on Cancer, which was commissioned by President George H.W. Bush.
“Dr. Pazdur’s work at the FDA opens the door to potentially allow many countries – including China – to review applications for new therapies simultaneously and make an independent decision to provide scientific innovation and medicines to patients in their own countries much faster, saving many years of laborious regulatory work,” said Dr. Li. “Another critical piece of this international collaboration is diversity, not only of the obligation to care for patients regardless of demographic background, but also scientific diversity in terms of expanding enrollment in clinical trials to increase the biological understanding of the disease. The FDA is leading this cause by promoting multi-regional trials and unified drug development standards across nations.”
A Focus on Lung Cancer and Precision Drug Development
At the moment, the MSK-CTONG collaboration focuses on clinical trials of precision cancer therapies for lung cancer, which remains the leading cause of cancer death in both China and the U.S. Precision cancer therapies involve developing drugs that target genetic or proteomic changes in cancer cells, the tumor microenvironment, or a patient’s own immune system. While these therapies may provide a more effective means of controlling the disease with fewer side effects than traditional approaches, it remains challenging to develop personalized approaches.
Dr. Li said, “At MSK, we are leading the charge in precision medicine, but with current challenges in the clinical trial enrollment – particularly in finding a diverse audience with specific mutational profiles – we are not advancing this research as much as we’d like. Learning more from China’s vast cancer population may be the answer to achieving clinical trial results that are generalizable across borders.”
Looking Forward
Dr. Charles Rudin, Chief of the Thoracic Oncology Service at MSK, and Dr. Valerie Rusch, thoracic surgeon and Vice Chair for Clinical Research, Department of Surgery at MSK, urged MSK and CTONG clinical researchers to collaborate on joint studies and clinical trials in the new year. Two new MSK-CTONG led international trials of precision medicines are now in the process of activation.
Dr. Li and others concluded the Symposium by reminding colleagues that they are all part of an international movement of science that requires a multi-stakeholder global effort among academia, industry, government regulatory agencies, and patients. Dr. Li added that pending control of the COVID-19 pandemic, the fifth annual MSK-CTONG Symposium will be hosted in-person in December 2022 at the Asia Society in Manhattan.