Even though next-generation sequencing is recommended by the National Comprehensive Cancer Network (NCCN) for biomarker testing for patients with non–small cell lung cancer (NSCLC), the uptake among community oncology practices is suboptimal, and the uptake is even lower among Black patients with NSCLC than for White patients. Biomarker testing is of the utmost importance in patients with NSCLC, since there are effective targeted therapies available for at least seven genetic alterations and use of these targeted therapies improves outcomes for patients with these alterations compared with chemotherapy and immunotherapy.

At the 2021 ASCO Annual Meeting, two different presentations explored the use of biomarker testing in the United States. The first study focused on U.S. Oncology Network community practices comprising more than 1,000 providers across the country and found that less than 50% of patients were tested for five major biomarkers (ALK, BRAF, EGFR, PD-L1, and ROS-1).¹ The second study showed that 39% of Black patients with metastatic NSCLC underwent next-generation sequencing compared with 50% of their White counterparts, which may explain the fact that more than double the percentage of White patients enroll in NSCLC clinical trials compared to Black patients, since clinical trials often use biomarker testing for enrollment.²

MYLUNG Consortium Study

Results from the first phase of the collaborative MYLUNG Consortium research protocol were based on a retrospective observational chart review of 3,474 adult patients with metastatic NSCLC who initiated first-line systemic therapy within the U.S. Oncology Network practices between April 1, 2018, and March 31, 2020. The authors documented testing rates for ALK, BRAF, EGFR, PD-L1, and ROS-1, use of next-generation sequencing, time from diagnosis to first-line therapy, turnaround time from biomarker orders to results, and time from NSCLC diagnosis to test results.

Results of this real-world study showed that there is much work to be done to overcome barriers and optimize patient care within U.S. Oncology Network community practices, and presumably this is generalizable throughout the country. Although the majority of patients received biomarker testing for at least one biomarker prior to initiation of therapy, only 46% of patients were tested for all five biomarkers and 37% of patients underwent next-generation sequencing.

More than 80% of patients with NSCLC were diagnosed at stage IV when the disease is not curable, and the median time from diagnosis to initiation of first-line therapy was about 5 weeks. Turnaround time from orders to test results was about 2 weeks.

There are already several targeted therapies available to treat subsets of populations [based on biomarker testing]… Unfortunately, barriers exist that prevent the necessary comprehensive biomarker testing that enables use of these treatments.

— Makenzi Evangelist, MD

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“The pace and development of treatments in NSCLC is dramatic,” said presenting author Makenzi Evangelist, MD, of New York Oncology Hematology, one of the practices in the Network. “There are already several targeted therapies available to treat subsets of populations [based on biomarker testing], and many more therapies are in the pipeline that hold incredible potential. Unfortunately, barriers exist that prevent the necessary comprehensive biomarker testing that enables 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.”

The data indicated that the uptake of next-generation sequencing improved over time, providing a better opportunity for comprehensive testing, Dr. Evangelist said.

Racial Disparities in Biomarker Testing

Racial disparities in access to cancer care are well documented, and several studies show poorer outcomes for various cancer types among Black vs White Americans. So, it comes as no surprise that a retrospective observational study based on the Flatiron Health database found that Black patients with NSCLC were less likely to get next-generation sequencing than White patients and less likely to enroll in clinical trials.

“Lung cancer is the leading cause of cancer-related deaths in the United States. NSCLC accounts for 85% of all lung cancer cases, most of which are diagnosed at advanced stages. The 5-year overall survival for stage IV is around 6%. We know that biomarker-driven therapies improve overall survival,” said lead author Debora S. Bruno, MD, of The MetroHealth System, Cleveland.

“Currently there are seven genomic alterations and three PD-L1 subsets of stage IV NSCLC that have been identified. Since 2020, the U.S. Food and Drug Administration has approved four targeted therapies for stage IV NSCLC harboring MET exon 14 skipping, RET, and ALK fusions,” she continued.

We found that Black Americans have significantly lower utilization of next-generation sequencing compared to their White counterparts and that Blacks were 55% less likely to be treated within a clinical trial.

— Debora S. Bruno, MD

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The retrospective cohort study aimed to determine racial differences in biomarker testing, use of targeted therapy, and clinical trial enrollment among patients in the United States diagnosed with advanced or metastatic NSCLC.

The study included 14,768 patients with advanced or metastatic NSCLC enrolled in the longitudinal Flatiron Health database: 9,793 (60%) were White, and 1,288 (8.7%) were Black. At least one molecular test or comprehensive genomic analysis was administered to 76.4% of White patients and 73.65% of Black patients (P = .03). Next-generation sequencing was performed on 50.1% of White patients vs 39.8% of Black patients, a 10% difference that was statistically significant (P < .0001). Next-generation sequencing was conducted prior to first-line therapy in 36.6% of White patients and 29.7% of Black patients (P < .0001).

Participation in clinical trials was double in White patients compared to Black patients: 3.9% and 1.9%, respectively (P = .0002).

“We found that Black Americans have significantly lower utilization of next-generation sequencing compared to their White counterparts and that Blacks were 55% less likely to be treated within a clinical trial,” Dr. Bruno emphasized.

DISCLOSURE: Dr. Evangelist has served in a consulting or advisory role for AstraZeneca and Takeda. Dr. Bruno has served in a consulting or advisory role for Tempus and received research funding from AstraZeneca.

REFERENCES

1. Robert NJ, Nwokeji E, Espirito JL, et al: Biomarker tissue journey among patients with untreated metastatic non-small cell lung cancer (mNSCLC) in the U.S. Oncology Network community practice. 2021 ASCO Annual Meeting. Abstract 9004. Presented June 4, 2021.

2. Bruno DS, Hess LM, Xiaohong L, et al: Racial disparities in biomarker testing and clinical trial enrollment in non-small cell lung cancer. 2021 ASCO Annual Meeting. Abstract 9005. Presented June 4, 2021.