MYLUNG consortium: prospective evaluation of molecular testing practices in patients with newly diagnosed non-small cell lung cancer in a real-world setting
Earlier this year, retrospective results of the MYLUNG consortium identified important shortcomings in routine molecular testing for patients with metastatic non-small cell lung cancer (NSCLC) and the use of these test results in therapeutic decision making. Protocol 2 of this large scale, real-world initiative will address the operational feasibility of obtaining comprehensive biomarker data and their use to personalize treatment in a retrospective manner.
Most of the improvements in lung cancer mortality can be ascribed to discovery of molecular drivers, immunotherapy and utilization of drugs targeting these alterations. However, despite national organizations endorsing comprehensive biomarker testing for patients with NSCLC, there remain to be obstacles towards routine molecular testing and its use in therapeutic decision making. To address this, The US Oncology Network initiated a real-world research program (MYLUNG™) with the objective to pragmatically identify and overcome these barriers and facilitate a timely and appropriate comprehensive biomarker testing in a large community based diverse population of patients with NSCLC.
A first part of this initiative consisted of a retrospective cohort study including 3,474 NSCLC patients and evaluated biomarker testing patterns, results, and initial treatment over a 2-year period. At the end of this period (March 31, 2020), this study showed that while most patients had at least 1 biomarker test result prior to initiating their first line treatment, still less than half had a test result for all biomarkers available at the last time period. In addition, the study identified a clear need to improve the test turnaround time. In fact, the time from the metastatic NSCLC diagnosis to the start of the treatment was a median of 35 days. The median time between the test order and the availability of the results ranged from 10-15 days for the different biomarkers. To build further on these results, the MYLUNG™ initiative now announced two subsequent protocols looking into these and other issues with molecular testing in a prospective manner.
Prospective evaluation of molecular testing practices in metastatic NSCLC
Protocol 2 is a prospective, non-interventional cohort study evaluating the current testing practices of patients with newly diagnosed NSCLC who are candidates for systemic therapy. This observational longitudinal study will describe a variety of patient characteristics, community practice characteristics, workflow processes, treatment patterns, and outcomes. The target enrolment for this cohort is ~1000 patients with histologically or cytologically documented early stage (excluding IA), locally advanced, and advanced NSCLC. Of note, patients who developed mNSCLC after receiving adjuvant or neoadjuvant therapy are eligible if the adjuvant/ neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease. The study will enrol patients that are found to be eligible for active systemic therapy across up to 20 community practices in The US Oncology Network. Enrolment began in January 2021 and is expected to continue for 9 to 12 months.
The primary objectives of the study will be to define the operational feasibility of obtaining comprehensive biomarker data (i.e. PD-L1 testing to guide the use of immunotherapies and testing for all genomic alterations for which we have FDA approved therapies including, but not limited to, EGFR, ALK, ROS1, BRAF, NTRK, MET, RET, and KRAS). The study will also document patients receiving single gene vs comprehensive testing for actionable mutations and will determine the percentage of patients who do and do not receive biomarker test results prior to starting systemic therapy or death. Reasons for not performing biomarker testing among those who start systemic therapy without test results will also be documented. In addition, investigators will compare patients who receive biomarker testing results and targeted treatment at any line of therapy to those receiving first line chemoimmunotherapy for mNSCLC and switch to targeted therapy after receiving test results.
As secondary endpoints, the study will determine the proportion of patients placed on biomarker directed first treatment regimen. For patients who have received biomarker test results with at least one actionable mutation, the study will assess the reason for not prescribing biomarker targeted therapy. Also the time span between first systemic therapy and the date of the initial presentation, the diagnostic biopsy, the first medical oncology visit, the biomarker test order and the availability of the test results will be documented. Finally, the study will determine the variance in biomarker testing patterns and biomarker driven treatment patterns by community cancer clinic settings (i.e., percentage of comprehensive biomarker testing ordered, type of test ordered, and resulting treatment), determine differences in comprehensive biomarker testing based on socio economic status and patient characteristics ( ie , age, gender, ethnicity, smoking status, geographic location, rural or urban, education, insurance, income and ECOG status) and look into differences in frequency of NGS testing beyond first treatment regimen compared to before first treatment.
The information obtained in this second protocol will be used to identify an initial set of workflow and technology interventions to be tested in Protocol 3, which is estimated to begin enrolment in the spring of 2022. This protocol 3 will be a platform of prospective interventional trials, engaging up to 20 resource and geographically diverse practices in The US Oncology Network including approximately 7,500 patients. Over the next 5 years, MYLUNG will evaluate biomarker testing workflows and algorithms, provider acceptance and use of biomarker results to inform treatment decisions, and appropriate adoption of new treatments as they become approved for use in patients with NSCLC.
Reference
Evangelist M, et al. MYLUNG Consortium: Molecularly Informed Lung Cancer Treatment in a Community Cancer Network. Pragmatic Prospective RWR Study. Presented at the 2021 World Conference on Lung Cancer; Abstract P60.13.
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