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. 2025 May 20;25(1):900.
doi: 10.1186/s12885-025-14313-7.

EGFR exon 20 insertions mutation in lung adenocarcinoma and its response by high-dose of Furmonertinib: a real-world study

Sen Yang #  1   2 , Yang Liu #  3 , Jiuzhou Zhao #  4 , Zhen He  1   2 , Haiyang Chen  1   2 , Shuxiang Ma  1   2 , Yingxi Wu  1   2 , Yufeng Wu  1   2 , Lili Wang  1   2 , Cuicui Zhang  1   2 , Qiming Wang  5   6
Affiliations

EGFR exon 20 insertions mutation in lung adenocarcinoma and its response by high-dose of Furmonertinib: a real-world study

Sen Yang et al. BMC Cancer. .

Abstract

Background: LUAD patients with EGFR exon 20 insertions (ex20ins) have a poorer prognosis than those with EGFR 19del or L858R mutations. The FAVOUR study showed high-dose furmonertinib's efficacy in ex20ins patients. However, more real-world data are needed to validate these findings.

Methods: We summarized LUAD patients who underwent NGS testing at Henan Cancer Hospital from January 1, 2020, to December 31, 2022. We then reviewed cases of patients with EGFR exon 20 insertion (ex20ins) mutations who received high-dose furmonertinib (240 mg/day) and had follow-up data. We assessed the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to treatment failure (TTF), overall survival (OS), and treatment-related adverse events (TRAEs).

Results: A total of 3,571 patients underwent NGS testing, with 1,632 (45.70%) identified as having EGFR mutations, including 87 (2.44%) with exon 20 insertions (ex20ins). Follow-up data were complete for 21 ex20ins patients treated with 240 mg/d of furmonertinib. Thirteen had prior treatments, including targeted therapy, and four had received EGFR-TKI. By March 1, 2024, 18 patients progressed, and 13 died. The ORR was 52.40% (11/21), DCR was 100%, median PFS was 6.15 months, TTF was 10.78 months, and OS was 21.67 months. Among the 18 progressing patients, 11 had neurological progression, six had thoracic progression, and two had liver progression. Diarrhea was the most common adverse event, and no patients discontinued treatment due to AEs.

Conclusions: Among LUAD patients, 2.44% harbored EGFR exon 20 insertions (ex20ins), and furmonertinib at 240 mg/d demonstrated efficacy and was well-tolerated in this real-world study of LUAD patients with EGFR ex20ins mutations.

Keywords: EGFR; EGFR ex20ins; Furmonertinib; Lung adenocarcinoma.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study has been approved by the Ethics Committee of the Affiliated Cancer Hospital of Zhengzhou University (2022-247-003), adhering to Helsinki Declaration, with informed consent waived due to its retrospective nature. Consent for publication: This manuscript has not been published or presented elsewhere in part or in entirety, and is not under consideration by another journal. All the authors have approved the manuscript and agree with submission to your esteemed journal. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
As of the follow-up date from January 1, 2021, to March 1, 2024, after treatment with 240 mg/d furmonertinib, 10 patients achieved PR and 1 patient achieved CR. The ORR was 52.4% (11/21). Lesions were stable in 9 patients, and in one case, the disease was stable but the lesion was not measurable. DCR: 100% (21/21)
Fig. 2
Fig. 2
In 21 patients with advanced LUAD harboring EGFR ex20ins mutations treated with 240 mg/d furmonertinib, the median PFS was 6.15 months (A), the median TTF was 10.78 months (B), and the median OS was 21.67 months (C) as of the follow-up date from January 1, 2021, to March 1, 2024
Fig. 3
Fig. 3
As of the follow-up date from January 1, 2021, to March 1, 2024, among the 21 patients with advanced LUAD harboring EGFR ex20ins mutations, 13 had received prior systemic therapy, while 8 had not. Compared with patients who received prior systemic therapy, those who did not had significantly longer PFS (A), TTF (B), and OS (C). Of the 21 patients, 10 had central nervous system (CNS) metastasis, and 11 did not. Patients without CNS metastasis tended to have prolonged PFS (D), TTF (E), and OS (F) compared to those with CNS metastasis
Fig. 4
Fig. 4
A patient diagnosed with LUAD harboring an EGFR exon 20 insertion mutation on September 17, 2021, began treatment with almonertinib (a third-generation EGFR-TKI with a standard dose of 110 mg QD) at 165 mg QD from September 24, 2021. The curative effect was evaluated as SD until February 14, 2022, when progressive PD was confirmed. Subsequently, the patient switched to 240 mg/d furmonertinib (standard dose 80 mg QD) and achieved PR after two months of treatment
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