MYLUNG Study Links Timely Biomarker Testing to Improved Outcomes in mNSCLC

Key Takeaways:

• In Protocol 2 of the MYLUNG study, 98.8% of patients with metastatic non–small cell lung cancer (mNSCLC) received biomarker testing, with 79.0% receiving test results before first-line treatment initiation.
• Among patients who received test results before beginning treatment, nearly one-fourth were identified as having an actionable alteration, with most beginning targeted first-line therapy rather than chemotherapy or immunotherapy.
• Patients who received biomarker test results before treatment initiation and underwent targeted therapy had better progression-free survival (PFS) and overall survival (OS) than those who began treatment before receiving biomarker results.

Since therapies targeted toward genetic alterations among patients with mNSCLC are associated with improved outcomes, the National Cancer Comprehensive Network (NCCN) recommends biomarker testing for all patients with mNSCLC to identify actionable alterations.

The MYLUNG Study

The Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium (MYLUNG) Program evaluated biomarker testing patterns in community settings. The first phase of the study, Protocol 1, was a retrospective chart review. Protocol 2 assessed testing practices, treatment patterns, and survival outcomes among patients with NSCLC undergoing first-line therapy.

Protocol 2 enrolled 556 adults with newly diagnosed mNSCLC who were treated across 18 community practices within the US Oncology Network from December 2020 to September 2022.

Patients were assigned to 1 of 4 cohorts:

• Cohort 1: Received biomarker test results before treatment initiation
• Cohort 2: Received biomarker test results after treatment initiation
• Cohort 3: Did not undergo biomarker testing
• Cohort 4: Underwent biomarker testing and received no treatment or 1 cycle of therapy

Biomarker Testing Rates

Most patients (98.8%) underwent biomarker testing, while only 7 patients (1.3%; Cohort 3) received no testing. This is an improvement from Protocol 1, where 89.9% of the sample population received biomarker testing. Cohort 1 included 79.0% of all patients, Cohort 2 included 11.2%, and Cohort 4 had 8.6%.

The primary reason for initiating treatment before biomarker test results was physician decision (47.9%), followed by barriers to test ordering (25.4%), insufficient tumor tissue (12.7%), and clinical deterioration (11.3%).

Among patients in the first cohort, 94 (21.4%) had an identified actionable alteration. The most common mutations were EGFR (66.0%), ALK (12.8%), MET (10.6%), BRAF (8.5%), RET (2.1%), and ROS1 (1.1%). Of these 94 patients, 73 (77.7%) received targeted first-line therapy, and 9 (9.6%) were enrolled in a clinical trial.

Guideline-compliant 8-gene biomarker testing occurred among 63.5% of patients, with 44.1% receiving test results before treatment initiation. Patients with nonsquamous histologies were more likely to receive guideline-compliant testing than those with squamous histologies, 57.1% and 9.5%, respectively.

Next-generation sequencing (NGS) testing increased between Protocol 1 and Protocol 2. Overall testing increased from 37.0% to 72.8%, and test result reception before therapy initiation increased significantly from 5.0% to 55.6%.

Survival Outcomes

Patients who received test results before beginning first-line therapy had a median OS 6.8 months longer than those who began treatment before receiving test results.

Patients with an actionable alteration who received targeted first-line therapy had an improved median PFS (24.18 months vs 14.85 months) and OS (32.79 months vs 24.64 months) compared to those who received first-line chemotherapy or immunotherapy.

Challenges in Biomarker Testing

Testing rates, though improved, remain suboptimal. Approximately 40% and 30% of patients did not receive guideline-compliant testing or NGS testing, illustrating gaps in biomarker testing practices. Barriers to testing include operational challenges, lack of communication and awareness, access disparities, and financial challenges.

Another challenge is turnaround time between test ordering and test results. Longer turnaround times have been associated with nontargeted treatment, which may result in worse health outcomes. Reflexive test ordering and in-house biomarker testing may reduce turnaround times.

Implications for Oncology Care

The study highlights how enhancements in biomarker testing practices can improve survival outcomes among patients with mNSCLC. Researchers also identified various areas for improvement along with recommended interventions to address these gaps.

According to the authors, “By examining various aspects of biomarker testing in community oncology practices, this study provides valuable real-world insights into the implementation of biomarker-driven care in settings where most patients with cancer are diagnosed and treated.”

Reference

Evangelist M, Wong B, Butrynski JE, et al. Biomarker testing rates and patterns in patients with metastatic non-small cell lung cancer: a prospective, observational study in community practices. JCO Precision Oncol. 2026;10(4):e2500832. doi:10.1200/PO-25-00832