Background:In the past decade, therapies targeting EGFR, KRAS, ALK, ROS1, BRAF, NTRK, MET, RET,HER2 and PD-L1 were approved and recommended by National Comprehensive Cancer Network (NCCN) for use in advanced non-small cell lung cancer (aNSCLC). This study compared real-world clinical outcomes in biomarker positive patients with aNSCLC who received treatments based on the NCCN NSCLC Guidelines (v5.2021) versus other therapies in the US.

Methods:This is a retrospective cohort study of patients with aNSCLC using the TEMPUS oncology dataset. Patients were included if they were diagnosed with stage IIIB-IV NSCLC (index date) between 1/1/2012 and 12/31/2020, ≥18 years of age at index, were biomarker (i.e., EGFR, KRAS, ALK, ROS1, BRAF, NTRK, MET, RET, or PD-L1) positive, and received at least one line of treatment. Patients were stratified by NCCN recommended treatment (v5.2021) receipt anytime following aNSCLC diagnosis. Median overall survival (mOS), progression free survival (mPFS), and time to next treatment (mTTNT) were evaluated by treatment group using Kaplan Meier analysis. Patient demographic and clinical characteristics were evaluated as potential predictors of receipt of NCCN recommended therapy.

Results:Of the 2,158 biomarker positive patients who met study criteria, 55.7% (N=1,201) received NCCN recommended treatment. PDL1 (38.0%), EGFR (32.2%), and/or KRAS (30.3%) were the most common over-expressions/mutations. Biomarker positive patients with aNSCLC treated with NCCN recommended treatment (N=1,201) in any line had significantly longer mOS (24.7mo, 95% CI: 22.5–27.6) than those treated with non-recommended treatment (N=957, 19.8mo, 95% CI: 17.5–22.6) (p<0.001). Biomarker positive patients with aNSCLC treated with NCCN recommended treatment also had significantly longer mPFS (8.5mo, 95% CI: 7.9–9.0) and mTTNT (20.6mo, 95% CI:19.3–23.7) than those treated with non-recommended treatment (4.9mo, 95% CI: 4.5–5.4) and (11.0mo, 95% CI: 10.0–12.7), respectively (both p<0.001). Never smokers (vs current smokers), patients of unknown or other race (vs whites), and patients who received 2 or more lines of treatment (vs 1) were more likely to receive NCCN recommended treatment and those with squamous or other/unknown histology (vs non-squamous) or missing ECOG scores (vs ECOG 0) were less likely to receive NCCN recommended treatment.

Conclusions:In this study, biomarker positive patients with aNSCLC who received NCCN recommended treatment had significantly longer mOS, mPFS, and mTTNT than those who were treated with non-recommended regimens. Following the recommendations of the NCCN NSCLC Panel improves real-world clinical outcomes among biomarker positive patients with aNSCLC. Meanwhile, some biomarker positive patients—including current smokers and those with squamous cell histology—were less likely to receive targeted treatments.

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