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Poster Display session 1

2982 - Safety and activity of alflutinib in patients with advanced EGFR T790M mutation non-small cell lung cancer who progressed after EGFR-TKI therapy

Date

28 Sep 2019

Session

Poster Display session 1

Topics

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Yuan-Kai Shi

Citation

Annals of Oncology (2019) 30 (suppl_5): v602-v660. 10.1093/annonc/mdz260

Authors

Y. Shi1, S. Zhang2, X. Hu1, J. Feng3, Z. Ma4, J. Zhou5, N. Yang6, L. Wu7, W. Liao8, X. Han9, Z. Wang10, X. Zhang11, S. Qin12, K. Ying13, J. Feng14, J. Fang10, L. Liu15, Y. Jiang16

Author affiliations

  • 1 Department Of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100021 - Beijing/CN
  • 2 Department Of Oncology, Beijing Chest Hospital, Capital Medical University,, Beijing/CN
  • 3 Department Of Medical Oncology, Jiangsu Cancer Hospital, Nanjing, China, Nanjing/CN
  • 4 Department Of Respiratory Medicine, Henan Province Cancer Hospital, Zhengzhou, China, Zhengzhou/CN
  • 5 Department Of Respiratory Medicine, The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, China, Hangzhou/CN
  • 6 Department Of Pulmonary Oncology, Hunan Cancer Hospital, Changsha/CN
  • 7 Department Of Gastroenterology, Hunan Cancer Hospital, Changsha/CN
  • 8 Department Of Medical Oncology, Nanfang Hospital, Nanfang Medical University, Guangzhou, China, Guangzhou/CN
  • 9 Department Of Medical Oncology, Beijing Key Laboratory Of Clinical Study On Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100021 - Beijing/CN
  • 10 Department Of Pulmonary Oncology, Peking University Cancer Hospital, Beijing, China, Beijing/CN
  • 11 Department Of Medical Oncology, Nantong Tumor Hospital, Nantong, China, Nantong/CN
  • 12 Medical Oncology, PLA Cancer Center of Bayi Hospital Affiliated to Nanjing University of Chinese Medicine, Nanjing, China, 100049 - Nanjing/CN
  • 13 Department Of Respiratory Medicine, Sir Run Run Shaw Hospital, Affiliated With Zhejiang University School of Medicine, Hangzhou, China, Hangzhou/CN
  • 14 Department Of Respiratory Medicine, Affiliated Hospital of Nantong University, Nantong, China, Nantong/CN
  • 15 Department Of Thoracic Oncology, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China, Wuhan/CN
  • 16 Clinical Affairs And Regulatory Department, Shanghai Allist Pharmaceuticals Inc., Shanghai, China, Shanghai/CN

Resources

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Abstract 2982

Background

Alflutinib (AST2818) is an irreversible EGFR-TKI selective for EGFR T790M mutation. We aimed to assess the safety and efficacy of alflutinib in advanced non-small cell lung cancer (NSCLC) patients with EGFR T790M mutation, who progressed after the first- or second-generation EGFR-TKI therapy.

Methods

In the phase I/II open-label, single-arm, dose-escalation and dose-expansion studies, patients with confirmed EGFR T790M mutation, locally advanced or metastatic NSCLC, who progressed after prior EGFR-TKI therapy, received alflutinib ranging from 20 - 240 mg orally once daily until disease progression or unacceptable toxicity. Patients with asymptomatic, stable central nervous system (CNS) metastases were included. The primary efficacy endpoint was the objective response rate (ORR), assessed by independent radiological review committee, in patients who received at least 1 dose with measurable disease at baseline in the dose-expansion study. Safety was assessed in all treated patients.

Results

Between Dec 27, 2016, and Oct 30, 2018, 130 (14 from dose-escalation, 116 from dose-expansion) patients received alflutinib treatment (2, 9, 48, 53, 18 patients in 20, 40, 80, 160 and 240 mg groups, respectively). By Oct 30, 2018, 79 (61%) patients remained on treatment. No dose limiting toxicity was observed. Median duration of alflutinib treatment was 226 (range: 3 - 513) days. The ORR in all treated patients was 76.7% (89/116; 95% CI: 68.0 - 84.1), duration of response ranged from 72 - 294+ days, disease control rate was 82.8% (96/116 patients). The ORR in patients with CNS metastases was 58.8% (10/17). No clear dose-response relationship was observed. Among 130 patients, 123 (95%) had treatment-related adverse events (TRAEs, including possibly not-related cases); 21 (16%) patients had grade 3 or 4 TRAEs, with the most common being decreased neutrophil count (4 patients). 20 (15%) patients had 31 serious adverse events (SAEs), 15 (12%) of them had 22 treatment-related SAEs. Five out of six deaths were due to AEs.

Conclusions

Alflutinib has promising efficacy and acceptable toxicity profile for NSCLC patients with EGFR T790M mutation who progressed after EGFR-TKI therapy. Further investigation is ongoing.

Clinical trial identification

NCT02973763, NCT03127449.

Editorial acknowledgement

Ping Liu (Linking Truth Technology Co. Ltd., China), funded by Shanghai Allist Pharmaceuticals Inc., China.

Legal entity responsible for the study

Shanghai Allist Pharmaceuticals Inc., China.

Funding

Shanghai Allist Pharmaceuticals Inc., China.

Disclosure

Y. Jiang: Full / Part-time employment: Shanghai Allist Pharmaceuticals Inc., China. All other authors have declared no conflicts of interest.

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