Researchers from Diaceutics and the Personalized Medicine Coalition published a special report in JCO Precision Oncology yesterday that provides an in-depth look at United States health systems’ efforts to deploy potentially paradigm-shifting targeted and immuno-oncology drugs to improve care for lung cancer patients.

The study, which was conducted in consultation with a cross-sector committee of PMC members using data from the Diaceutics Data Repository, examined de-identified Medicare claims and laboratory data from 38,068 patients diagnosed with advanced non-small cell lung cancer in 2019 to show that due to the influence of testing and treatment difficulties occurring at each of seven steps in the precision oncology pathway, diagnostic testing-informed treatment strategies benefitted only 36 percent of the patients in the cohort whose tumors potentially expressed actionable biomarkers. The article, titled “The Impact of Clinical Practice Gaps on the Implementation of Personalized Medicine in Advanced Non-Small Cell Lung Cancer,” identifies seven ways in which clinical practice gaps limit the extent to which breakthroughs in personalized medicine benefit patients in clinical settings.

For every 1,000 patients in the cohort, the study authors concluded that:

1. In 6.6 percent of the studied cases (66 out of 1,000 patients), the patient could not benefit from personalized medicine because clinicians never attempted to collect the tumor tissue or blood samples needed to uncover actionable biomarkers.
2. In an estimated 14.5 percent of the studied cases (136 out of 934 patients for whom biopsy was attempted), the patient could not benefit from personalized medicine most likely because clinicians’ attempts to collect the necessary tumor tissue or blood samples were unsuccessful.
3. In an estimated 1.7 percent of the studied cases (14 out of 798 successfully biopsied patients), the patient could not benefit from personalized medicine most likely because the collected biospecimen did not contain enough tumor cells to allow for testing to uncover actionable biomarkers.
4. In 18.1 percent of the studied cases (142 out of 784 patients whose biopsies had enough tissue or blood to test), the patient could not benefit from personalized medicine because clinicians did not order the genetic or genomic sequencing-based testing necessary to uncover actionable biomarkers.
5. In 18.3 percent of the studied cases (118 out of 642 patients who received the necessary testing), the patient could not benefit from personalized medicine because genetic or genomic sequencing-based testing delivered inconclusive or false-negative results, usually for technical reasons or because of known testing limitations.
6. In 4.0 percent of the studied cases (21 out of 524 patients who received conclusive testing results), the patient could not benefit from personalized medicine most likely because long turnaround times for test results prompted physicians and patients to initiate treatment regimens before testing results were available.
7. In 29.2 percent of the studied cases (147 out of 503 patients who tested positive for an actionable biomarker), the patient did not benefit from personalized medicine because clinicians did not prescribe a targeted or immuno-oncology therapy the patient could have benefitted from.

The study findings represent a first step toward understanding and pinpointing the nuances behind testing and treatment difficulties preventing millions of people from getting the health care they need. While the study was conducted using data about advanced non-small lung cancer cases in the United States, the findings may reflect clinical gaps across other geographies and cancer types.

“This study reminds us that personalized medicine will not occur just because the science suggests it should,” said PMC President Edward Abrahams. “Only standardized test processing, broader educational initiatives, and additional studies to demonstrate the clinical and economic benefits of personalized medicine will deliver its promise to patients.”

“Precision medicine brings a more promising future to the millions of patients undergoing cancer treatment,” said Susanne Munksted, Chief Precision Medicine Officer at Diaceutics. “Despite this, it is clear there are many clinical practice gaps which limit the impact of treatment. This study therefore represents a call to action, requiring a multi-stakeholder approach, combined with insights from real-world patient level data. Through this, we can better understand the steps needed to ensure patients are able to receive the right treatment at the right time.”