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Clinical Utility of Cell-Free Genomic Profiling in Advanced Lung Adenocarcinoma

Conference Correspondent

For the practice of precision medicine, somatic genomic testing is recommended to inform targeted therapy decisions for patients with advanced lung adenocarcinoma. In support of this recommendation, the prospective multicenter North American community-based observational NILE study (NCT03615443) demonstrated noninferiority of cell-free circulating tumor DNA (cfDNA)-based tumor genotyping compared with tissue-based genotyping to identify actionable genomic alterations in newly diagnosed patients with advanced lung adenocarcinoma; clinical outcomes data of the study were reported at the ASCO 2021 meeting.

For patients enrolled in the NILE study, samples for genomic analyses were collected using standard tissue genotyping and concurrent comprehensive cfDNA analysis (Guardant360 assay). Efficacy outcomes data, including objective response rates, disease control rate, and time to treatment, were analyzed after 12 months of study enrollment and treatment with physician’s choice of therapy based on actionable genomic alterations identified.

A total of 282 patients were enrolled in the study; of these, 89 (31.6%) had an actionable genetic alteration. Of the 89 patients with actionable genetic alterations, 61 (68.5%) were treated with a US Food and Drug Administration–approved targeted agent targeting EGFR, ALK, or ROS1. Of the 33 patients evaluable for response evaluation, an objective response rate of 58% and a disease control rate of 94% were achieved; 25 (76%) patients and 17 (52%) patients achieved a durable response of >6 months and >12 months, respectively. The time to treatment was significantly shorter when cfDNA genotyping versus tissue genotyping was used (P = .0008).

These community-based real-world data support the use of cfDNA to identify actionable genomic alterations in newly diagnosed patients with advanced lung adenocarcinoma.

Source: Page RD, et al. J Clin Oncol. 2021;39(suppl 15):Abstract 9027.

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