Lung Cancer: FDA Collaboration Highlights Real-world Immunotherapy Treatment Patterns

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Study findings suggest that some clinicians are using immunotherapies in the types of patients not included in clinical trials.
Study findings suggest that some clinicians are using immunotherapies in the types of patients not included in clinical trials.

Though the first PD-1 inhibitors were approved for non–small cell lung cancer (NSCLC) in 2015, it is not well-known how these agents are being used in the real-world, particularly in community-based clinics.

To address this, the US Food and Drug Administration (FDA) partnered with Flatiron Health to determine how PD-1 inhibitors are being used outside of the clinical trial setting.1

According to Amy P. Abernethy, MD, PhD, chief medical officer and senior vice president of oncology at Flatiron Health in New York, New York, a major driver for this research collaboration is that clinical trial cohorts often do not reflect the real-world population receiving treatment. She noted, for example, that “elderly patients and underrepresented minorities are disproportionately excluded from clinical trials. Hence, real-world data can help us fill in the gaps in knowledge about how to optimally treat these patients.”

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Real-world Immunotherapy Use for NSCLC

Dr Abernethy told Cancer Therapy Advisor that “the study was initiated as a way of understanding patterns of care and patient experience when immunotherapies are routinely prescribed for the care of patients with advanced NSCLC — what is the same and what is different from results seen in clinical trials?”

The retrospective observational study used data from the Flatiron Health Electronic Health Record database from over 260 community cancer clinics to identify 1344 patients with metastatic NSCLC who received nivolumab or pembrolizumab between January 2011 and March 2016.2

Structured data, such as laboratory testing results, and unstructured data, including pathology reports and medical care notes, were extracted by technology-enabled chart abstraction. Unstructured data were reviewed manually by trained abstractors. Quality control was conducted on a number of variables.

The median age of patients at anti-PD-1 antibody initiation was 69 (interquartile range [IQR], 61-75), and 27% of patients were older than age 75. This cohort was generally older than the cohorts from the nivolumab and pembrolizumab clinical trials, in which the median age ranged from 62 to 66, with less than 10% of patients aged older than 75.

“I think it is notable that, in the real-world, over a third of patients were over age 65 and 27% were over age 75. These are not the patients usually included in clinical trials. Understanding how these patients are going to do, both in terms of effectiveness and toxicity, will be really important,” Dr Abernethy said.

The Flatiron cohort was 55.6% male; 88% of the cohort had a history of smoking. Though the majority of the cohort was Caucasian (69.6%), there were also African American (5.7%), Asian (3.1%), and other minority (8.5%) patients, and 13.2% were of unknown race/ethnicity.

Just 8.3% of patients were tested for PD-L1 expression levels prior to initiating anti–PD-1 therapy; mutational analysis of EGFR and ALK rearrangements was performed among 64% and 61% of patients, respectively. “Although a test result was not required for use upon the initial immunotherapy approvals, we were anticipating more clinicians would seek out this information to help guide their treatment decisions,” Dr Abernethy commented.

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