Osimertinib in the treatment of EGFR mutation–positive advanced non-small cell lung cancer: A meta-analysis.

e20723 Background: Osimertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) used for the treatment of advanced EGFR-mutated non-small cell lung cancer (NSCLC). This meta-analysis systematically reviews the evidence on the effectiveness and safety of osimertinib in treating advanced non-small cell lung cancer with EGFR mutations. Methods: Following PRISMA guidelines, we systematically searched PubMed, Embase, Cochrane, and ClinicalTrials.gov from inception to July 2025. Randomized controlled studies that reported the efficacy and safety of osimertinib versus other treatments (chemotherapy, other EGFR-TKIs, etc.) in treating EGFR-mutated NSCLC were included. Data analysis was performed using RevMan 5.4, with risk ratios (RRs) and 95% confidence intervals (CIs) calculated for dichotomous outcomes using a random-effects model. Risk of bias was assessed using the Cochrane RoB 2.0 tool. The primary endpoints were objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). The additional outcome was the incidence of adverse events. Results: A total of 23 RCTs involving 7,525 participants were included. Among them, 4,061 participants were in the osimertinib group, while 3,444 were in the standard treatment group. Meta-analysis indicated that PFS (RR 0.74, 95% CI, 0.58–0.95, p = 0.02, I² = 94%) and OS (RR 0.81, 95% CI, 0.70–0.94, p = 0.006, I² = 72%) in the experimental group were statistically significant compared to the control group. ORR (RR 1.36, 95% CI, 1.14–1.62, p = 0.0005, I² = 93%) and DCR (RR 1.13, 95% CI, 1.04–1.22, p = 0.004, I² = 90%) also yielded statistically significant results but favored the control group. Among the reported adverse events, the experimental group showed a statistically significant reduction in the incidence of nausea (RR 0.51, 95% CI, 0.31–0.83, p = 0.007, I² = 80%) and vomiting (RR 0.34, 95% CI, 0.14–0.79, p = 0.01, I² = 78%) compared to the control group. The control group showed a statistically significant reduction in diarrhoea (RR 1.30, 95% CI, 1.02–1.65, p = 0.03, I² = 80%). The incidence of fatigue, rash, and loss of appetite favored the experimental group, but the results were insignificant. The incidence of URTI, rash, and stomatitis was higher in the control group, but the reduction was statistically insignificant. Conclusions: This meta-analysis suggests that osimertinib is an effective and well-tolerated treatment strategy for advanced non-small cell lung cancer (NSCLC) with EGFR mutations. This meta-analysis has several limitations, including heterogeneity among included studies, potential publication bias, and variability in study quality and sample sizes.