A unique public-private collaboration among the National Cancer Institute (NCI), part of the National Institutes of Health, SWOG Cancer Research, Friends of Cancer Research (Friends), the Foundation for the National Institutes of Health (FNIH), the US Food and Drug Administration (FDA), five pharmaceutical companies (Amgen, Genentech, Pfizer, AstraZeneca, and AstraZeneca’s global biologics R&D arm, MedImmune), and Foundation Medicine announced the initiation of the Lung Cancer Master Protocol (Lung-MAP) trial on June 16th. Below, some of the leaders of this trial talk about what Lung-MAP means from their perspective.
David Gandara, UC Davis, Lung-MAP Co-Principal Investigator
"This is an entirely new way of looking at the development of cancer drugs. This is no longer business as usual. This approach changes the paradigm.”
Vali Papadimitrakopoulou, MD Anderson, Lung-MAP Co-Principal Investigator
"Multitarget screening can increase the ‘hit rate’ and provide for uninterrupted accrual. This, in turn, will create a path to approval for safer and more effective drugs, while replacing ineffective ones."
Roy Herbst, Yale University, Lung-MAP Co-Principal Investigator
“It changes the idea of one test one drug. That is the future, actually it is the present, it is just the way it has to be done.”
Charles Blanke, MD, Chair, SWOG
"Lung cancer, like many other neoplasms, is increasingly recognized as consisting of a host of relatively rare genomic subsets, each of which may require treatment with a different targeted drug. The Lung-MAP S1400 trial models a way to efficiently study a large number of these rare subsets under one master protocol."
Ellen Sigal, Ph.D., Chair and Founder, Friends of Cancer Research
“This diverse, collaborative approach, with support from leading lung cancer advocacy organizations, helps to ensure that the needs of patients, clinicians, developers, and regulators are all considered in the design and operation of the trial.”
Dr. Maria Freire, President and Executive Director of FNIH
“Traditional clinical trials have long imposed significant recruitment and infrastructure burdens on researchers and patients, with frustratingly slow results,” said Maria Freire, Ph.D., President and Executive Director of the FNIH. “This master protocol will allow multiple enrollees to be tested once and assigned to a treatment likely to work for them, rather than separate tests for separate trials with most patients ineligible. This strategy will validate biomarkers and facilitate drug development in one infrastructure, to more rapidly provide safer and more effective treatments to patients.”
Vincent Miller, M.D., Foundation Medicine
“Squamous cell carcinoma of the lung is a deadly cancer killer and like many common solid tumors analysis of no one or even several genes provides a sufficiently comprehensive characterization of the actionable alterations present in a population of patients to ensure a high screen hit rate when evaluating patients for a targeted therapy approach. Rather, multiple genes often altered by one or more classes of DNA changes and often co-occurring are unpredictably altered in any given patient. The comprehensive, broad based nature of FoundationOne testing allowed us to be uniquely suited to provide reliable results across an unprecedented broad swath of predictive biomarkers in a clinically relevant TAT to attract multiple interested pharma partners with distinct therapeutic targets”.
Bahija Jallal, PhD, Executive Vice President of AstraZeneca and head of MedImmune
“Both AstraZeneca and MedImmune are pleased to join our partners as part of this exciting new paradigm in oncology drug development,” said Dr. Bahija Jallal, Executive Vice President, MedImmune. “One of our key company priorities is to bring innovative new treatments to patients in need as quickly as possible. Lung-MAP is unique, as it will expand options and ultimately help improve treatment outcomes by identifying the targeted therapies best suited to meet the specific needs of patients with squamous lung cancer, one of the deadliest cancers.” - Bahija Jallal, PhD, Executive Vice President of AstraZeneca and head of MedImmune
Dr. Mace Rothenberg, Senior VP, Clinical Development and Medical Affairs, CMO for Pfizer Oncology
“The Lung-MAP trial is important in two ways. It uses genomic information to assign patients to an investigational therapy and it brings together key stakeholders – industry, academia, advocacy and government – to advance precision medicine research and development,” said Dr. Mace Rothenberg, senior vice president, Clinical Development and Medical Affairs, and chief medical officer, Pfizer Oncology. “Pfizer is proud to be part of this important collaboration, which has the potential to make a significant impact on the future of oncology drug development and, most important, lead to more effective treatment options for patients with lung cancer.”
Andrea Stern Ferris, President and Chairman, LUNGevity Foundation
“LUNGevity is delighted that the Lung-MAP trial is launching this ambitious, strategic approach with squamous cell lung cancer, an area of great promise and great need. Collaboration in clinical trial design has the potential to dramatically increase the efficiency of recruiting patients and getting new treatment options to our lung cancer patient population more quickly.”
Bonnie J. Addario, Founder and Chair, Addario Lung Cancer Foundation
"The collaborative effort put in place for the LUNG Master Protocol is a game changing process. It will revolutionize the way clinical trials are conducted, leading the way to more rapid drug development and approval for patients. For the first time a trial will begin with the focus on the patient and personalize their therapy to their tumor mutations rather than the reverse.”
"The collaborative effort put in place for the LUNG Master Protocol is a game changing process. It will revolutionize the way clinical trials are conducted, leading the way to more rapid drug development and approval for patients. For the first time, a biomarker-driven lung cancer clinical trial will begin with the patient as the focus of the trial, and personalizing therapy to the specific mutations in their tumor, unlike the traditional method of focusing on the drug and testing who responds to it. This unprecedented public-private partnership will drive us closer to the precision medicine era where each patient gets personalized therapy for their disease, instead of blanket therapy that might not be the right treatment of choice for them, boosting survival and saving more lives."
Holli Kawadler, PhD, Uniting Against Lung Cancer
“Uniting Against Lung Cancer is excited to support this innovative clinical trial helping patients with squamous cell lung cancer, a deadly type of lung cancer with a critical need for improved treatments. This new model is a game changer for lung cancer patients, quickly matching them with the treatment option most likely to be effective from a panel of possibilities. We are pleased to be a part of this unprecedented collaborative effort on behalf of lung cancer patients.”
Leonard Lichtenfeld, MD, MACP, Deputy Chief Medical Officer, American Cancer Society
“Our advancing knowledge about cancer has provided a dramatic opportunity to improve the care we offer our patients. At the same time, we must find new approaches to find out which treatments will work best for which patients. As a result we must focus our efforts on getting new drugs to patients more quickly and effectively. This means trying new ways of designing and implementing clinical trials to show whether or not a drug works, as well as the side effects of that drug. The Lung Cancer Master Protocol—designed in collaboration with experts in lung cancer treatment, researchers, governmental and non-profit voluntary agencies and pharmaceutical companies among others, is a bold step forward in improving this process. The American Cancer Society is proud to support this innovative initiative.”
Regina Vidaver, Ph.D., Executive Director, Free to Breathe
“Lung-MAP represents an unprecedented approach to quickly gain information on which new drugs will be best suited to treat people with squamous cell lung cancer. We encourage everyone who is facing a diagnosis of squamous cell lung cancer to join this clinical trial. All participating patients will have their tumors tested for the mutations or other characteristics that drive the growth of their specific cancer, and then be matched to a clinical trial based on the results of those tests. All patients will receive the best possible care, whether that is through the best known chemotherapy options, or a new drug or set of drugs designed to attack their tumor’s particular characteristics. “
Laurie Fenton Ambrose, President and CEO, Lung Cancer Alliance
“Lung Cancer Alliance is proud to participate in this innovative and first of its kind effort to expedite research discoveries for those with squamous cell lung cancer.”
Lung-MAP is a unique, public-private, and collaborative clinical trial. In this post, some of the leaders of the trail discuss what Lung-MAP means from their perspective.