First Phase Results of MYLUNG Consortium Provide Historical View of Biomarker Testing Patterns and Identify Data Gaps for Ongoing Prospective Research
Over 80% of non-small cell lung cancer detected at stage 4.
Results from the first phase of the broad, collaborative MYLUNG ConsortiumTM research study in metastatic non-small cell lung cancer (mNSCLC) were released by The US Oncology Network (The Network), US Oncology Research and OntadaTM at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
The findings provide a close-up look at current biomarker testing rates and turnaround times for patients with mNSCLC treated in community practices within The Network. Most notably, Protocol 1 findings show that there are barriers that must be addressed as more than 80 percent of NSCLC is detected at Stage 4 and median time from diagnosis to first-line therapy is about five weeks.
“The pace and development of treatments in non-small cell lung cancer is dramatic,” said Makenzi Evangelist, MD, principal investigator for the MYLUNG Consortium’s Protocol 2 and oncologist with New York Oncology Hematology (NYOH), a practice in The Network. “There are already several targeted therapies to treat subsets of populations, and many more are in the pipeline that hold incredible potential. Unfortunately, barriers exist that prevent the necessary comprehensive biomarker testing that enables the use of these treatments. The MYLUNG Consortium study will be invaluable in identifying these obstacles and developing practical interventions that will allow us to fulfill the promise of precision medicine for patients with this difficult cancer.”
Dr. Evangelist presented the findings during an oral presentation at ASCO titled, “Biomarker tissue journey among patients with untreated metastatic non-small cell lung cancer (mNSCLC) in The US Oncology Network community practices.” (ASCO Abstract 9004).
The MYLUNG Consortium is a collaborative and innovative research study comprised of three protocols over a five-year period. Protocol 1, which was just completed, is a retrospective study of more than 3,500 patients with mNSCLC that investigated the following areas: testing rates for ALK, BRAF, EGFR, ROS1, and PD-L1 mutations; use of the full next-generation sequencing panel (NGS); time from NSCLC diagnosis to first-line therapy; turnaround times from biomarker orders to results; and time from NSCLC diagnosis to test results.
“We have derived significant insights from the study data so far,” noted Sarah Alwardt, PhD, vice president of Operations for Ontada. “We are now able to see where there are gaps regarding targeted therapy. This real-world study showed that while most patients had at least one biomarker test result available prior to first-line therapy, less than 50 percent had five or more biomarkers tested. Consequently, a large percentage of patients were not given the opportunity for a targeted therapy.”
Additionally, the median time from diagnosis to first-line therapy was about five weeks, a concern for patients anxiously waiting for treatment. Turnaround time from testing orders to results was about two weeks, indicating the need to get test results to physicians sooner so they have all critical information in front of them during development of the treatment plan. Next Generation Sequencing testing improved over time, suggesting comprehensive testing is increasing. Most of the population was diagnosed at advanced disease, with roughly over 80 percent detected at stage 4.
“Protocol 1 provides a look at what was happening retrospectively based on clinical data abstraction, allowing us to draw some early conclusions about historical baseline trends for testing patterns,” noted Robert L. Coleman, MD, FACOG, FACS, chief scientific officer of US Oncology Research and the MYLUNG Consortium program principal investigator. “Retrospective studies like this help us understand where we are as far as testing behaviors, while also identifying gaps in the data that need to be filled with the prospective research the MYLUNG Consortium will address in the next protocols.”
Data from Protocol 1 will be compared to the next phase of the MYLUNG Consortium study, Protocol 2, which will evaluate contemporary ordering practices and turnaround times prospectively. It will enroll about 1,000 patients from approximately 11 sites and will monitor the real-world patient journey from presentation through their first line of cancer therapy, focusing on how diagnostic biomarker information is obtained, utilized and operationalized in decision-making. Patients are currently being enrolled in this stage of the study.
The final phase of the study, Protocol 3, will serve as a platform upon which prospectively assessed interventional strategies in patient-engagement algorithms will be conducted. Up to 7,500 patients from approximately 20 participating sites will be recruited over a five-year period. Individual clinical trials will integrate findings from the previous protocols and explore new processes and associated outcomes. The goal is to help providers make the best treatment recommendations based on the data available while improving access to testing and appropriate therapies for patients with mNSCLC.
The MYLUNG Consortium study is enabled through a unique collaboration of various organizations and stakeholders working together across the spectrum of NSCLC drug development, therapy and care. The number of consortium participants continues to grow, all bringing unique perspectives to this innovative study. It brings together providers and researchers in The Network, US Oncology Research and Ontada with life sciences companies Amgen, AstraZeneca, Eli Lilly and Company, Genentech (a member of the Roche Group), and Mirati Therapeutics, Inc. Patient advocacy groups LUNGevity and GO2 Foundation for Lung Cancer are also participating, playing a key role in the study by keeping the focus on patients. Healthcare provider members include Illinois Cancer Specialists, Maryland Oncology Hematology, Minnesota Oncology, New York Oncology Hematology, Oncology Hematology Care, Rocky Mountain Cancer Centers, Southern Cancer Center, Virginia Cancer Specialists, Virginia Oncology Associates, Willamette Valley Cancer Institute and Research Center and Woodlands Medical Specialists.
About The US Oncology Network
Every day, The US Oncology Network (The Network) helps approximately 1,400 independent physicians deliver value-based, integrated care to patients — close to home. Through The Network, these independent doctors come together to form a community of shared expertise and resources dedicated to advancing local cancer care and to delivering better patient outcomes. The Network provides practices with access to coordinated resources, best business practices, and the experience, infrastructure and support of McKesson Corporation. This collaboration allows the providers in The Network to focus on the health of their patients, while McKesson focuses on the health of their practices. The Network is committed to the success of independent practices, everywhere.