Abivertinib in patients with T790M-positive advanced NSCLC and its subsequent treatment with osimertinib
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Updated: Dec 30, 2025

Establishment and Characterization of Three Afatinib-resistant Lung Adenocarcinoma PC-9 Cell Lines Developed with Increasing Doses of Afatinib
Published on: June 26, 2019
Hanping Wang1, Ruili Pan1, Xiaotong Zhang1
1Department of Respiratory Medicine, Peking Union Medical College Hospital, Beijing, China.
Background:
Abivertinib is a novel oral, third generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that overcomes T790M-induced resistance in non-small cell lung cancer (NSCLC) patients. Here, we report the results of a complete and detailed clinical data of patients treated with abivertinib at our hospital in a phase I dose escalation/expansion study of abivertinib.
Methods:
NSCLC patients with the EGFR T790M mutation were orally administered abivertinib (150-300 mg) twice daily for cycles of 28 continuous days and tumor response was assessed. Further data regarding subsequent treatment protocols and survival were collected.
Results:
A total of 28 NSCLC patients were included. Of the 24 assessable patients, 12 (50%) achieved a partial response (PR), and six (25%) achieved stable disease (SD). Median progression-free survival (PFS) was 5.9 months (95% confidence interval (CI): 3.259-8.541) and median overall survival (OS) was 17.9 months (95% CI: 11.36-24.5). For salvage therapy in 15 (53.6%) patients after abivertinib, the median PFS following osimertinib treatment was 12 months. The median total treatment duration for the two third-generation EGFR TKIs was 15.9 months (95% CI: 12.5-19.3). The most frequent abivertinib-associated adverse effects were elevated hepatic transaminases (10/28, 35.7%) and diarrhea (10/28, 35.7%).
Conclusions:
Abivertinib is a unique novel third-generation EGFR TKI with good tolerance and efficacy in EGFR T790M(+) NSCLC patients. For patients with progressive disease after treatment with abivertinib, osimertinib could be an option for subsequent therapy but further studies are required.
Key Points:
Abivertinib is a novel third-generation EGFR TKI targeting the EGFR T790M mutation Abivertinib is well tolerated and efficacious in T790M-positive patients Abivertinib has a unique structure, efficacy, and resistance mechanism compared with osimertinib Osimertinib treatment after AC0010 showed a good response.
Insights
Abivertinib demonstrates good tolerance and efficacy in non-small cell lung cancer (NSCLC) patients with EGFR T790M mutations. Osimertinib may be a viable subsequent therapy option for patients experiencing progressive disease after abivertinib treatment.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Abivertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).
- It is designed to overcome T790M-induced resistance in non-small cell lung cancer (NSCLC).
Purpose of the Study:
- To report clinical data from a phase I study of abivertinib in NSCLC patients.
- To assess the efficacy and safety of abivertinib in patients with EGFR T790M mutations.
Main Methods:
- NSCLC patients with EGFR T790M mutation received oral abivertinib (150-300 mg) twice daily.
- Tumor response, survival data, and subsequent treatment protocols were assessed.
Main Results:
- Of 24 assessable patients, 50% achieved partial response and 25% achieved stable disease.
- Median progression-free survival was 5.9 months and median overall survival was 17.9 months.
- Common adverse effects included elevated hepatic transaminases and diarrhea.
Conclusions:
- Abivertinib shows good tolerance and efficacy in EGFR T790M-positive NSCLC patients.
- Osimertinib may be a subsequent therapy option for patients with progressive disease after abivertinib, warranting further investigation.
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