MSK-CTONG Symposium participants at the annual meeting on December 2, 2022.
Global regulatory harmonization of clinical trials provides significant opportunity to accelerate access to cancer treatments to benefit all of humanity. This was the theme of the fifth annual MSK-CTONG Symposium, hosted online for a global audience of 20,000 from Guangzhou, China, and New York on December 2, 2022.
The Chinese Thoracic Oncology Group (CTONG), an alliance of more than 30 premier academic cancer centers in China, in collaboration with the Bobst International Center at Memorial Sloan Kettering Cancer Center (MSK), presented scientific, educational, and regulatory aspects of clinical trials for new cancer therapies to help millions of patients worldwide. Sir Murray Brennan, MSK’s Senior Vice President of International Programs, shared the collective mission of the MSK-CTONG Symposium: “to bring the United States, China, and the world together to conquer cancer.”
MSK has played a leadership role in promoting international collaboration and regulatory harmonization across different countries to accelerate testing and approvals of cancer treatments. A recent MSK-led study in collaboration with Asia Society and the Bloomberg New Economy International Cancer Coalition showed that international regulatory harmonization can potentially save 1-2 million lives every year. (1) Bob Li, MSK’s Physician Ambassador to China and Asia-Pacific, shared the progress being made in bringing international clinical trials to patients through the MSK-CTONG collaboration. For now, the collaboration is focused on clinical trials of precision cancer therapies for lung cancer, which remains the leading cause of cancer death in both the U.S. and China.
“Accelerating the cure for cancer requires multi-stakeholder partnerships to provide greater access for patients enrolling in international clinical trials,” said Dr. Li. Since 2018, the MSK-CTONG collaboration has expanded the availability of new cancer drugs in the U.S., China, and other countries, while facilitating international patient care between Guangzhou and New York, educational exchange among U.S.-China physicians, and global regulatory dialogue with government.
Advancing Common Goals
“Collaboration in the fight against cancer represents an important opening for the U.S. and China to re-energize their relationship,” said the Honorable Dr. Kevin Rudd, Asia Society President and CEO, and the 26th Prime Minister of Australia. The Asia Society Policy Institute (ASPI) works to tackle major policy challenges confronting countries in the Asia-Pacific region. Within the continued framework of international regulatory protections, strategic guardrails, managed competition, and national security, Rudd said, “That’s where this continued collaboration falls, between MSK here in the United States, and CTONG in China, working together on what President Biden has already called the Cancer Moonshot initiative, and what multiple U.S. presidents have dedicated, going right back to President Nixon. as being a mission for all countries in the world to cure this insidious disease.”
“These game-changing efforts have helped millions of cancer patients and families, including myself,” said Dr. Jing Qian, the Founding Managing Director of the Center for China Analysis at ASPI in New York. Partnering to conquer this common enemy for humanity was the inspiration for the international Cure4Cancer movement. “With heighted public awareness, with the political space open, with policy and innovation readily available, it is up to us,” said Qian, “to empower patient-centric cancer treatment globally, and to provide peace for the millions of cancer families, as we fight this common enemy of humanity.”
Project Orbis: Opportunity for Enhanced Collaboration
“I thank you for inviting me to this important conference. I have always had an international perspective, and we firmly believe the world is better served by having multi-regional clinical trials,” said Dr. Richard Pazdur, Director of the FDA Oncology Center of Excellence (OCE), a signature accomplishment of President Biden’s original White House Cancer Moonshot initiative in 2016. Sharing the recent success of Project Orbis, Dr. Pazdur reported that new communication channels between international regulatory agencies have accelerated timelines of new drug applications for patients across the world.
Project Orbis was created in 2019 to enable the U.S. FDA and agencies in multiple countries to simultaneously review clinical trial data, thus reducing duplication and delay in regulatory submissions and shortening the time needed for patients to access innovative cancer medicines. These efforts aim to improve quality of care worldwide. Dr. Pazdur explained how it works: “We ask pharmaceutical companies to have simultaneous submissions to countries where there is a significant delay in submission. In many instances, this delay was a matter of months, but many times, it was years, as patients were delayed in getting important cancer drugs. We would work with these countries to review applications in a relatively expeditious fashion.”
Through year-end 2021, Project Orbis has been used in 75 FDA applications for new oncology indications, with 35% being new molecular entities, and 250 applications were submitted globally across eight partnering countries — the U.S., Canada, Australia, Switzerland, Singapore, Brazil, the U.K., and Israel.
Additional initiatives of the OCE that may benefit from international collaboration include Project Pragmatica, which aims to simplify clinical trials by replicating real-world experiences and trying not to over-complicate trial design by collecting unnecessary data.
Bi Jingquan, Executive Vice Chairman of the China Center for International Economic Exchanges in Beijing, and former Commissioner of the China Food and Drug Administration, reflected on how the U.S. and China can work together to promote regulatory collaboration on cancer clinical trials. “The MSK-CTONG Annual Symposium is an important platform for China-U.S. collaboration and exchange in the fight against cancer. It is also an important reflection of the collaboration between the two countries’ medical and scientific communities in fighting cancer and promoting the health of humanity,” said Chairman Bi, who urged Dr. Pazdur to use his influence to help remove obstacles so that the “China National Medical Products Administration (NMPA) can become an official member of Project Orbis to promote simultaneous regulatory reviews between the two countries and accelerate cancer drug approvals.”
Chairman Bi highlighted China’s regulatory infrastructure reform in becoming a member of the International Council for Harmonisation (ICH) in 2017, having adopted international standards. He emphasized, “In recent years China has made substantial progress in the development of its biopharmaceutical industry, with abundant medical resources and a huge market,” expressing confidence that China “can contribute more towards the global fight against cancer.”
Other distinguished guest speakers included Justin Finnegan, Managing Director APAC, Bloomberg New Economy, and Russell Flannery, Editor-at-Large, Forbes Magazine.
A Focus on Liquid Biopsy to Identify Residual Disease
The Scientific Panel opened with enthusiasm surrounding customization of treatments for the individual patient. The first speaker, Dr. Pedram Razavi, Director of Liquid Biopsy and Genomics of the global Biomarker Development Program at MSK, presented results from liquid biopsy-guided clinical trials. Dr. Razavi noted the limitations of the current treatment of patients with early-stage solid tumors, but emphasized the use of standard risk assessments and predictive tests.
“We should not disregard the decades of existing data, but instead add to our knowledge and improve designs by adding liquid biopsy assessment,” he said. He shared clinical trial designs of MSK’s guided treatment strategies using liquid biopsy to detect circulating tumor DNA (ctDNA) biomarkers in patients and group patients with minimal residual disease (MRD).
“By adding liquid biopsy to current assessments, patients can be stratified into subgroups—true MRD positive vs. MRD negative disease and monitored for response to therapy at the molecular level,” concluded Dr. Razavi. “There is a real opportunity to make a meaningful impact on patient outcomes if patients with MRD are identified and intercepted earlier to treat.”
Democratizing Access to Biomarker Technology
Dr. Jorge Reis-Filho, Chief, Experimental Pathology at MSK, shared the hospital’s mission to accelerate development and democratize access to biomarker technology through partnerships to generate the evidence required for biomarkers to be adequately deployed. Dr. Reis-Filho’s presentation focused on using artificial intelligence (AI) to enable access to complex biomarkers and specialized pathology expertise. AI technology can quickly and accurately analyze tissue slides to identify phenotypic and even genotypic traits, along with opportunities to discover novel biological subtypes. Through an international collaboration with Brazil, MSK performed the first real-world validation of the first and only FDA-approved AI system to detect prostate cancer in prostate biopsies.
Additional panels focused on the eXalt 3 Study for ALK positive lung cancer, Design and Implementation of Patient-Centric Clinical Trials, and Phase 1 Clinical Trials for Developmental Therapeutics. MSK leadership and faculty speakers included Jeffrey Drebin, Chair, Department of Surgery; Simon Powell, Chair, Department of Radiation Oncology; Larry Norton, Senior Vice President; Luis Diaz Jr., Head of Solid Tumor Oncology; Charles Rudin, Chief of Thoracic Oncology; Howard Scher, Head of Biomarker Development Program; Valerie Rusch, Vice Chair for Clinical Research, Department of Surgery; William Travis, Director of Thoracic Pathology; Fernando Santini, Attending Thoracic Oncologist; Gaetano Rocco, Attending Thoracic Surgeon; Isabel Preeshagul, Attending Thoracic Oncologist; Dazhi Liu, Early Drug Development Clinical Pharmacist; Nancy Lee, Vice Chair, Department of Radiation Oncology and Chief of Proton Therapy, and Si-Yang Liu, CTONG Visiting Investigator. CTONG leadership presence included Yi-Long Wu, President of CTONG; and Qing Zhou, President, Cancer Hospital of Guangdong Provincial People’s Hospital.
The Symposium concluded with a vision for the future. MSK’s work with CTONG and China is just one way to establish and strengthen international research partnerships that bring the world together to accelerate the cure for cancer. The international strategy is to expand our mission-driven partnerships with multiple academic, industry, government, media, and philanthropic stakeholders in other countries to accelerate clinical development and fast-track approvals of novel cancer treatments and prevention. Lifesaving breakthroughs may be made available to patients sooner, not only in the New York tri-state area, but to diverse patient populations worldwide—including underserved and remote communities.