Comparative effectiveness and safety of almonertinib in EGFR-mutated non-small cell lung cancer: an integrated evidence synthesis
- 1Department of Oncology, The First Affiliated Hospital of Xi’an Medical University , ,
- 2Department of Respiratory Medicine, Gansu Provincial Hospital , ,
- 3Department of Respiratory Medicine, Jining First People’s Hospital , ,
Abstract
Background: Comparative evidence regarding the efficacy and safety of almonertinib in epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) remains fragmented across randomized and real-world studies. We conducted a systematic review and meta-analysis to comprehensively evaluate the comparative clinical performance of almonertinib.
Methods: Eight electronic databases were systematically searched from inception to March 2025. Comparative studies evaluating almonertinib versus active control regimens in patients with EGFR-mutated NSCLC were included. Random-effects meta-analyses were performed to synthesize objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and treatment-related adverse events. Methodological quality was assessed using the Cochrane Risk of Bias tool and analogous domains for observational studies, and certainty of evidence was evaluated using the GRADE framework.
Results: Fifteen comparative studies involving 1,902 patients met the eligibility criteria. Compared with control regimens, almonertinib was associated with higher pooled ORR (RR = 1.33, 95% CI 1.08–1.65) and DCR (RR = 1.14, 95% CI 1.03–1.26). However, after trim-and-fill adjustment for potential publication bias, the 95% CIs for both ORR and DCR included the null value, suggesting that the observed response benefits may be influenced by small-study effects. No statistically significant differences were observed for pooled PFS or OS. Almonertinib demonstrated a generally favorable safety profile, with a lower incidence of diarrhea, while rates of grade ≥3 adverse events and other major toxicities were broadly comparable between groups. Integrated analyses further suggested consistent concordance between ORR and DCR across most studies, supporting improved short-term disease control despite moderate-to-substantial between-study heterogeneity.
Conclusion: Current comparative evidence suggests that almonertinib may improve tumor response and disease control while maintaining a favorable tolerability profile in patients with EGFR-mutated NSCLC. Although favorable objective response outcomes were observed, these benefits may be influenced by small-study effects, and definitive survival advantages remain uncertain. These findings support almonertinib as a clinically meaningful therapeutic option, while underscoring the need for cautious interpretation and for larger, high-quality comparative trials with longer follow-up to further define its long-term clinical value.
Systematic Review Registration: https://doi.org/10.17605/OSF.IO/ZDF2N ; Identifier: OSF.IO/ZDF2N.
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BibTeX
@article{rong2026comparative,
title = {{Comparative effectiveness and safety of almonertinib in EGFR-mutated non-small cell lung cancer: an integrated evidence synthesis}},
author = {Biaoxue Rong and Hui Pan and Tian Fu and Yanfeng Liu and Pan Yang and Jiaying Zhang and Ying Wang},
journal = {Frontiers in pharmacology},
year = {2026},
month = oct,
doi = {10.3389/fphar.2026.1932051},
url = {https://europepmc.org/article/PMC/PMC13690667},
note = {CC BY},
}
RIS
TY - JOUR
TI - Comparative effectiveness and safety of almonertinib in EGFR-mutated non-small cell lung cancer: an integrated evidence synthesis
AU - Biaoxue Rong
AU - Hui Pan
AU - Tian Fu
AU - Yanfeng Liu
AU - Pan Yang
AU - Jiaying Zhang
AU - Ying Wang
PY - 2026
DA - 2026/10/09
JO - Frontiers in pharmacology
DO - 10.3389/fphar.2026.1932051
UR - https://europepmc.org/article/PMC/PMC13690667
AB - Background: Comparative evidence regarding the efficacy and safety of almonertinib in epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) remains fragmented across randomized and real-world studies. We conducted a systematic review and meta-analysis to comprehensively evaluate the comparative clinical performance of almonertinib. Methods: Eight electronic databases were systematically searched from inception to March 2025. Comparative studies evaluating almonertinib versus active control regimens in patients with EGFR-mutated NSCLC were included. Random-effects meta-analyses were performed to synthesize objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and treatment-related adverse events. Methodological quality was assessed using the Cochrane Risk of Bias tool and analogous domains for observational studies, and certainty of evidence was evaluated using the GRADE framework. Results: Fifteen comparative studies involving 1,902 patients met the eligibility criteria. Compared with control regimens, almonertinib was associated with higher pooled ORR (RR = 1.33, 95% CI 1.08–1.65) and DCR (RR = 1.14, 95% CI 1.03–1.26). However, after trim-and-fill adjustment for potential publication bias, the 95% CIs for both ORR and DCR included the null value, suggesting that the observed response benefits may be influenced by small-study effects. No statistically significant differences were observed for pooled PFS or OS. Almonertinib demonstrated a generally favorable safety profile, with a lower incidence of diarrhea, while rates of grade ≥3 adverse events and other major toxicities were broadly comparable between groups. Integrated analyses further suggested consistent concordance between ORR and DCR across most studies, supporting improved short-term disease control despite moderate-to-substantial between-study heterogeneity. Conclusion: Current comparative evidence suggests that almonertinib may improve tumor response and disease control while maintaining a favorable tolerability profile in patients with EGFR-mutated NSCLC. Although favorable objective response outcomes were observed, these benefits may be influenced by small-study effects, and definitive survival advantages remain uncertain. These findings support almonertinib as a clinically meaningful therapeutic option, while underscoring the need for cautious interpretation and for larger, high-quality comparative trials with longer follow-up to further define its long-term clinical value. Systematic Review Registration: https://doi.org/10.17605/OSF.IO/ZDF2N ; Identifier: OSF.IO/ZDF2N.
SN - 1663-9812
ER -