Next-generation sequencing (NGS) completion and timeliness using reflex testing protocol for patients with stage II-III non-squamous non-small cell lung cancer (NS-NSCLC).

8060 Background: Genomic testing is important for early-stage NSCLC due to benefits of adjuvant EGFR and ALK targeted therapies and implications for neoadjuvant immunotherapy decisions. The purpose of this study is to evaluate the completion rates and timeliness of NGS prior to treatment initiation for patients with stage II-III NS-NSCLC, with reflex NGS testing protocols in place. Methods: Patients with stage II-III NS-NSCLC diagnosed between 2015 and 2022 at UVA Cancer Center were identified retrospectively. A reflex tissue-based NGS testing protocol was initiated at UVA in early 2015 using in-house TruSight Tumor and later PGDx platforms. Targeted pyrosequencing was performed in cases of NGS failures. The primary outcomes of the study were to evaluate the NGS completion rate and median time from biopsy to results and to any first line treatment (1L), including surgery, radiation, or systemic therapy. Actionable mutation incidence, proportion of patients with test results prior to treatment, and overall survival (OS) were all assessed. Statistical analysis included both descriptive statistics and Kaplan-Meier methodology for overall survival (OS). Results: 171 patients met eligibility, 92 (54%) female, 80 (47%) stage II and 91 (53%) stage III. 159 (93%) had known 1L start dates and 99 (58%) received systemic therapy with known dates. Testing completion rates and time to results are shown in the table. Actionable mutations identified included: KRAS 39% (G12C 15%), EGFR 7%, BRAF 4%, MET 2%, RET 1%, and NTRK 1%. There was no difference in NGS success rates between patients with stage II and III diseases, X 2 (1, N = 171) = 2.667, p = 0.102. Median OS was 64.1 months in those with complete NGS testing and 53.4 months in those without complete NGS (p=0.222). Conclusions: Reflexive, in-house NGS resulted in a shorter median time from biopsy to results (17 days) and higher completion rate (NGS, 77%; at least limited testing, 92%) compared to historical controls. The majority of patients had NGS results available to inform systemic therapy decisions (69%). While OS was numerically higher for patients with complete NGS, this was not statistically significant. Reflex NGS testing protocols increase the likelihood of obtaining timely results in the new era of adjuvant tyrosine kinase inhibitors and neoadjuvant chemotherapy and immunotherapy. Table: see text