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Mini Oral session 2

8MO - The efficacy and safety of TQ-B3101 monotherapy in the first line treatment in patients with ROS1 positive non-small cell lung cancer

Date

30 Mar 2022

Session

Mini Oral session 2

Topics

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Shun Lu

Citation

Annals of Oncology (2022) 33 (suppl_2): S27-S70. 10.1016/annonc/annonc856

Authors

S. Lu1, H. Pan2, L. Wu3, Y. Yao4, J. He5, Y. Wang6, X. Wang7, X. Wang8, X. Cai9, Y. Yu10, Z. Ma11, X. Min12, Z. Yang13, L. Cao14, H. Yang15, Y. Shu16, W. Zhuang17, S. Cang18, J. Fang19, K. Li20

Author affiliations

  • 1 Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai/CN
  • 2 Sir Run Run Shaw Hospital, Zhejiang University, Zhejiang/CN
  • 3 Hunan Cancer Hospital (The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University), Changsha/CN
  • 4 The First Affiliated Hospital of Xi’an Jiaotong University, Xian/CN
  • 5 The First Affiliated Hospital of Guangzhou Medical University, Guangzhou/CN
  • 6 National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing/CN
  • 7 Qilu Hospital of Shandong University, Jinan/CN
  • 8 The First Affiliated Hospital/School of Clinical Medicine of Guangdong Pharmaceutical University, Guangzhou/CN
  • 9 Sun Yat-sen University Cancer Center, Guangzhou/CN
  • 10 Harbin Medical University Cancer Hospital, 150000 - Harbin/CN
  • 11 Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou/CN
  • 12 Anhui Chest Hospital, Hefei/CN
  • 13 Affiliated Hospital of Guangdong Medical University, 510180 - Zhanjiang/CN
  • 14 Anhui Provincial Hospital, The First Affiliated Hospital of the University of Science and Technology of China, Anhui Provincial Hospital, Hefei/CN
  • 15 Xiangya Hospital Central South University, Changsha/CN
  • 16 Jiangsu Province People's Hospital, Nanjing/CN
  • 17 Fujian Cancer Hospital and Fujian Medical University Cancer Hospital, 350014 - Fuzhou/CN
  • 18 The Henan Province Hospital of Zhengzhou University, 450000 - Zhengzhou/CN
  • 19 Peking University Cancer Hospital & Institute, Beijing/CN
  • 20 Tianjin Medical University Cancer Institute and Hospital, Tianjin/CN

Resources

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Abstract 8MO

Background

TQ-B3101 is a novel small molecule receptor tyrosine kinase inhibitor, which targets to ALK, ROS1 and MET. Preclinical studies showed that it had a good tumor inhibition activity and duration. This study aims to evaluate the efficacy and safety of TQ-B3101 monotherapy in the first-line treatment in patients with ROS1-positive non-small cell lung cancer (NSCLC).

Methods

This is a multicenter, single arm phase II trial (NCT03972189). ROS1 positive locally advanced or metastatic NSCLC patients with ROS1-TKI treatment naïve were enrolled. TQ-B3101 was orally administered at dose of 300 mg BID in a 28-day cycle, until disease progression or intolerable toxicity. The primary endpoint was independent review committee (IRC) assessed objective response rate (ORR). The secondary endpoints included IRC assessed disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), intracranial ORR/DoR, intracranial time to progress and safety.

Results

As of October 15, 2021, 111 patients had received TQ-B3101 therapy (median age 52 yrs, 61.3% female, 71.2% ECOG PS 1, 92.8% stage IV, 29.7% with brain metastasis), with a median follow up of 12.1 months. 1 patient achieved complete response and 86 patients achieved partial response with ORR assessed by IRC of 78.4% (95% CI, 69.6%-85.6%) and DCR of 87.4% (95% CI, 79.7% - 92.9%). The median PFS assessed by IRC was 15.6 months (95% CI, 10.2 - 27.0) and median DoR was 20.3 (95% CI, 11.0 - 26.1). Median OS has not been reached and the 12- and 24-month OS rate were 98.1% and 88.1% respectively. Treatment related adverse events (TRAEs) occurred in 99.1% of patients (≥G3 TRAEs occurred in 45.1%). Treatment-related SAEs occurred in 3.6% of patients, and only 2 (1.8%) patients had treatment discontinuation due to TRAEs. Most common TRAEs were AST increased (73.9%), ALT increased (72.1%), emesis (63.1%), neutrophils count decrease (56.8%), leukocyte count decrease (52.3%), sinus bradycardia (52.3%), and diarrhea (43.2%).

Conclusions

For the first-line treatment of ROS1-positive locally advanced or metastatic NSCLC patients, TQ-B3101 showed the promising efficacy with a manageable safety profile, offering a new first-line therapeutic strategy.

Clinical trial identification

NCT03972189.

Legal entity responsible for the study

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Funding

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.

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