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Multicenter Study
. 2025 Jun;27(6):2568-2578.
doi: 10.1007/s12094-024-03776-y. Epub 2024 Nov 5.

A real‑world study of clinical characteristics, treatment sequence and outcomes of patients with non-small cell lung cancer and EGFR exon 20 insertion mutations

Guillermo Suay  1 , Paloma Martín-Martorell  2 , Francisco Aparisi  3 , María Arnal  4 , María Guirado  5 , Aitor Azkárate  6 , Javier Garde-Noguera  7 , José David Cumplido-Burón  8 , Amelia Insa  2 , José Francisco González-Muñoz  9 , Sarai Palanca  10 , María Díaz  11 , Alfredo Sánchez-Hernández  4 , Óscar Juan-Vidal  12
Affiliations
Multicenter Study

A real‑world study of clinical characteristics, treatment sequence and outcomes of patients with non-small cell lung cancer and EGFR exon 20 insertion mutations

Guillermo Suay et al. Clin Transl Oncol. 2025 Jun.

Abstract

Objectives: EGFR exon 20 insertion (EGFRex20ins) mutations are found in up to 4% of all patients with non-small cell lung cancer (NSCLC). These patients are often insensitive to EGFR-tyrosine kinase inhibitors (TKIs) and have worse prognosis than patients with more common EGFR mutations. In this multicenter, retrospective, real-world study, we sought to determine whether the administration of recently approved treatments that specifically target EGFRex20ins mutations could significantly improve outcomes in this patient population.

Materials and methods: We evaluated the clinical features of 41 patients diagnosed with NSCLC and EGFRex20ins mutations, their evolution, and response to treatments received across 7 hospitals in the Valencian Community, Spain, between 31st December 2012 and 31st December 2022.

Results: 32 patients (72%) developed metastatic disease, and 29 (71%) of them received oncological treatment. We found that administering a targeted therapy against EGFRex20ins mutations (amivantamab, mobocertinib and/or sunvozertinib) at some point during the course of treatment, significantly increased the median OS of metastatic patients from 8 months (95% CI 0-21.7) to 30 months (95% CI 11.1-48.8; Hazard ratio = 0.297, p = 0.02).

Conclusion: Our findings contribute to the evolving standard of care for this specific population and highlight the clinical benefits of targeted cancer therapies.

Keywords: EGFR exon 20 insertion mutations; Non-small cell lung cancer; Overall survival; Real-world data; Targeted therapies.

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Conflict of interest statement

Declarations. Conflict of interest: Suay G has received travel grants to attend oncology meetings from Janssen and Roche. Martín-Martorell P has received travel grants to attend oncology meetings from Roche, Astra-Zeneca and MSD. She is on speakers bureaus for Astra-Zeneca, BMS, Pfizer and Takeda, and is a PI/SI in clinical trials from Roche, Lilly, Janssen, Abbvie and Astra-Zeneca. Aparisi F has served in a consultant or advisory role for Pzifer and Boheringher Inghelheim. He has received speaker fees from Astra-Zeneca, Takeda and Sanofi, and travel expenses from Janssen, Gallecto, Pfizer, Roche, MSD and Takeda. Arnal M is on speakers bureaus for Astra-Zeneca, Roche, MSD, BMS, Pfizer, Takeda, Lilly and Janssen. Guirado M is on speakers bureaus for MSD and Takeda, and has received travel grants to attend oncology meetings from Roche. Azkárate A has received grant/research support from Astra-Zeneca and MSD, is on speakers bureaus for Astra-Zeneca, Roche, MSD, BMS, Pfizer, Takeda, Lilly and Janssen. He has received consultancy fees from Roche, Takeda, BMS and MSD, and is a PI/SI in clinical trials from Amgen, Mirati, Bayer, Takeda, Pfizer, Roche, AstraZeneca, Lilly and Janssen. Garde-Noguera J is on speakers bureaus for Astra-Zeneca, Roche, MSD, BMS, Pfizer, Takeda and Janssen. He has received grant/research support from BMS. Cumplido-Burón JD has received travel grants to attend oncology meetings from MSD. Insa A has received payment or honoraria for lectures or educational events from Astra-Zeneca, Amgen, Roche, Takeda and Pfizer. She has received support for attending meetings and/or travel expenses from Roche, Pfizer and MSD. She is on advisory boards for Astra-Zeneca, Sanofi and Pfizer. González-Muñoz JF is on Janssen’s speakers bureau. Palanca S has served in a consultant or advisory role for Roche, Astra-Zeneca, Lilly and Janssen. She has received speaker fees from Roche, Pfizer, Amgen, Astra-Zeneca, Takeda, Amgen and Lilly. She has received research funding from Roche and Astra-Zeneca, and grant support from Roche and Amgene. Díaz M has no conflicts of interest to declare. Sánchez-Hernández A is on speakers bureaus for Astra-Zeneca, Roche, MSD, BMS, Pfizer, Takeda, Lilly, Jansen, Amgen, Lilly and Novartis. She has also received consultancy fees from Roche, Takeda, BMS, MSD and Janssen. Juan-Vidal O has received honoraria or advisory role fees from Bristol-Myers Squibb, Roche/Genentech, AstraZeneca, Pfizer, Eli Lilly, Takeda and Janssen. He has received travel and accommodation grants from Takeda, Astra-Zeneca, Roche/Genentech, Pfizer and MSD. Ethical approval and informed consent: Ethical approval for this observational anonymized study (GIDO-2023-01) was obtained from the Clinical Research Ethical Committee from the Hospital Universitario y Politécnico La Fe of Valencia, Spain, with a favorable verdict. The Clinical Research Ethical Committee did not require an informed consent for the protocol, and an informal consent waiver was approved because the study is observational, patient data was anonymized, and the study does not include images that may identify the person.

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