P60.13 MYLUNG Consortium: Molecularly Informed Lung Cancer Treatment in a Community Cancer Network. Pragmatic Prospective RWR Study

Abstract

Recent improvements in lung cancer mortality can be ascribed to the discovery of molecular drivers, immunotherapy and utilization of drugs targeting these alterations. Despite national organizations endorsing comprehensive biomarker testing for patients with NSCLC, obstacles remain to routine testing and their use in driving therapeutic decisions. Engaging community practices within the US Oncology Network, we initiated a real world research program aimed to pragmatically identify and overcome barriers to timely and appropriate comprehensive biomarker testing in a large community-based diverse population of patients with lung cancer. Over the next 5 years, the MYLUNG program 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. The program is comprised of three principal and integrated components: Protocol 1 was a retrospective cohort study (N=3474 patients) evaluating biomarker testing patterns, results, and initial treatment over a 2-year period that ended in March 31, 2020. Protocol 2 is a prospective, non-interventional cohort study (described below) studying the current testing practices of patients with newly diagnosed NSCLC who are candidates for systemic therapy. Protocol 3 is a platform of prospective interventional trials, engaging 20-30 resource and geographically diverse practices in The US Oncology Network, which will enroll approximately 7500 patients. Protocol 2 practices will serve as their own controls for subsequent interventional trials in Protocol 3. Protocol 2 is a prospective, non-interventional study that will enroll approximately 1000 patients with histologically or cytologically documented early stage, locally advanced, and advanced non-squamous NSCLC who are eligible for active systemic therapy across 10 community practices in The US Oncology Network. The primary objective is to examine the proportion of patients who receive biomarker testing results prior to initiating systemic therapy or death, as well as reasons for initiating systemic therapy without biomarker test results, in order to define the operational feasibility of comprehensive biomarker testing. Secondary objectives include determining the proportion of patients that receive appropriate biomarker-directed treatment, and reasons for not receiving appropriate treatment. We will also examine timelines for the patient journey from initial presentation to diagnosis, biomarker test order and results, first medical oncology visit, and treatment initiation. Additionally, we will examine single versus multi-gene biomarker testing, progression-free survival (PFS) and overall survival (OS) of patients with molecular targets who receive FDA-approved targeted therapy versus patients receiving systemic therapy without biomarker results. We will quantify differences in biomarker testing rates based on socioeconomic status, ethnic diversity, and practice resources. Enrollment began in January 2021 and is expected to enroll for 9-12 months. Information obtained from Protocol 2 will be used to identify an initial set of workflow and technology interventions to be tested in Protocol 3, which is targeted to begin enrollment in the fall of 2021. ▪▪▪ ▪▪▪