A phase I/II study of osimertinib in EGFR exon 20 insertion mutation-positive non-small cell lung cancer

Yasuda, Hiroyuki; Ichihara, Eiki; Sakakibara‐Konishi, Jun; Zenke, Yoshitaka; Takeuchi, Shinji; Morise, Masahiro; Hotta, Katsuyuki; Sato, Mineyoshi; Matsumoto, Shingo; Tanimoto, Azusa; Matsuzawa, Reiko; Kiura, Katsuyuki; Takashima, Yuta; Yano, Seiji; Koyama, Junji; Fukushima, Takahiro; Hamamoto, Junko; Terai, Hideki; Ikemura, Shinnosuke; Takemura, Ryo; Goto, Kōichi; Soejima, Kenzo

doi:10.1016/j.lungcan.2021.10.006

Cited by 37 publications

(26 citation statements)

References 20 publications

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“… 27 At 80 mg of osimertinib, there was no objective response among 12 patients treated from a different study. 28 In comparison among the 114 platinum-pretreated patients, the ORR for mobocertinib in their “pivotal” registration trial was 28% (95% CI: 20–37), median PFS of 7.3 months (95% CI: 5.5–9.2) and median DOR was (95% CI: 7.4–20.3). 29 …”

Section: Introductionmentioning

confidence: 99%

Spotlight on Furmonertinib (Alflutinib, AST2818). The Swiss Army Knife (del19, L858R, T790M, Exon 20 Insertions, “uncommon-G719X, S768I, L861Q”) Among the Third-Generation EGFR TKIs?

Zhang¹,

Ou²

2022

LCTT

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Osimertinib, a third-generation (3G) epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) is now considered the standard of care for the first-line (1L) treatment of advanced EGFR + NSCLC due to statistically significant improved progression-free survival (PFS) and overall survival (OS) compared with first-generation (1G) treatment from the FLAURA trial. Recently two other 3G EGFR TKIs (aumolertinib and furmonertinib) have been approved in China for treatment of EGFR T790M+ NSCLC. Randomized Phase 3 trials of these two 3G EGFR TKIs have also demonstrated PFS over gefitinib respectively. Among these two Chinese home-grown, 3G EGFR TKIs, furmonertinib seems to most closely resemble osimertinib in terms of dosing regimen, efficacy and adverse events profile. In this article, we reviewed the clinical activity and adverse events of furmonertinib at 80 mg daily (approved dose), potential usage of 160 mg daily for CNS metastasis in EGFR + NSCLC, and usage of 160 mg or 240 mg daily in EGFR exon20 insertion positive ( EGFRex20ins +) NSCLC patients.

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Section: Introductionmentioning

confidence: 99%

Spotlight on Furmonertinib (Alflutinib, AST2818). The Swiss Army Knife (del19, L858R, T790M, Exon 20 Insertions, “uncommon-G719X, S768I, L861Q”) Among the Third-Generation EGFR TKIs?

Zhang¹,

Ou²

2022

LCTT

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“…Osimertinib is an oral, third-generation, irreversible EGFR-TKI approved for both classical-and EGFR T790M resistant mutations [14][15][16][17][18]. To date, the evidence regarding efficacy of osimertinib 80 mg daily in patients with EGFRex20 + NSCLC is disappointing [19][20][21][22][23]49] (see Supplementary Table 1, showing the efficacy of osimertinib in several trials). The results of the different studies showed that patients with EGFRex20 + NSCLC are heterogenous in their response to osimertinib 80 mg, in which patients harboring the A763_Y764insFQEA variant in the αC-helix showed better response in comparison to other near-and far loop EGFRex20 + mutations [24].…”

Section: Introductionmentioning

confidence: 99%

High dose osimertinib in patients with advanced stage EGFR exon 20 mutation-positive NSCLC: Results from the phase 2 multicenter POSITION20 trial

et al. 2022

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“…However, therapy options for patients with rare EGFR mutations have historically been lacking. Exon 20 insertion mutations are associated with de novo resistance to TKIs, and many TKIs, such as osimertinib and poziotinib, have been shown to have limited efficacy against exon 20 insertion mutations [ 21 , 22 ]. The limited efficacy of potential treatments has contributed to the poorer prognosis reported for these patients compared with patients with other EGFR mutations [ 23 ].…”

Section: Introductionmentioning

confidence: 99%

Prevalence of Epidermal Growth Factor Receptor Exon 20 Insertion Mutations in Non-small-Cell Lung Cancer in Europe: A Pragmatic Literature Review and Meta-analysis

et al. 2022

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Background Information on the epidemiology of uncommon EGFR mutations including exon 20 insertions amongst nonsmall-cell lung cancer (NSCLC) is lacking. Objective The objective of this pragmatic literature review (PLR) and meta-analysis was to generate robust prevalence and incidence estimates based on ranges of exon 20 insertion mutations reported in the literature. Materials and methods Searches of MEDLINE, Embase, congresses and reference lists for articles published from 2013 in key European countries of interest (

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A phase I/II study of osimertinib in EGFR exon 20 insertion mutation-positive non-small cell lung cancer

Cited by 37 publications

References 20 publications

Spotlight on Furmonertinib (Alflutinib, AST2818). The Swiss Army Knife (del19, L858R, T790M, Exon 20 Insertions, “uncommon-G719X, S768I, L861Q”) Among the Third-Generation EGFR TKIs?

Spotlight on Furmonertinib (Alflutinib, AST2818). The Swiss Army Knife (del19, L858R, T790M, Exon 20 Insertions, “uncommon-G719X, S768I, L861Q”) Among the Third-Generation EGFR TKIs?

High dose osimertinib in patients with advanced stage EGFR exon 20 mutation-positive NSCLC: Results from the phase 2 multicenter POSITION20 trial

Prevalence of Epidermal Growth Factor Receptor Exon 20 Insertion Mutations in Non-small-Cell Lung Cancer in Europe: A Pragmatic Literature Review and Meta-analysis

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