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Mini Oral session 2

7MO - Oritinib (SH-1028), a third-generation EGFR tyrosine kinase inhibitor in locally advanced or metastatic NSCLC patients with positive EGFR T790M: results of a single-arm phase II trial


30 Mar 2022


Mini Oral session 2


Targeted Therapy

Tumour Site

Non-Small Cell Lung Cancer


Caicun Zhou


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


C. Zhou1, A. Xiong1, J. Zhao2, W. Li3, M. Bi4, J. Chen5, K. Li5, L. Miao6, Y. Mao7, D. Wang8, C. Liu9, A. Zeng10, R. Li11, Y. Pan12, Y. Hu13, X. Zhang14, H. Niu15, Y. Du16, Y. Sun17, Z. Liu18

Author affiliations

  • 1 Shanghai Pulmonary Hospital, Shanghai/CN
  • 2 Xuzhou Central Hospital, Xuzhou/CN
  • 3 The First Affiliated Hospital of Bengbu Medical College, Bengbu/CN
  • 4 The First Affiliated Hospital of Bengbu Medical College, 233099 - Bengbu/CN
  • 5 Hunan Cancer Hospital, Changsha/CN
  • 6 Nanjing Drum Tower Hospital, Nanjing/CN
  • 7 The First Affiliated Hospital of Henan University of Science and Technology, Luoyang/CN
  • 8 Chongqing University Cancer Hospital, Chongqing/CN
  • 9 Center Hospital Affiliated to Xinjiang Medical University, Wulumuqi/CN
  • 10 Guangxi Medical University Affiliated Tumor Hospital, Nanning/CN
  • 11 Baoding NO.2 Central Hospital, Baoding/CN
  • 12 The First Affiliated Hospital of University of Sciences and Technology of China, 230000 - Hefei/CN
  • 13 Hubei Cancer Hospital, Wuhan/CN
  • 14 Nantong Cancer Hospital, Nantong/CN
  • 15 The First Affiliated Hospital of Xinxiang Medical College, Xinxiang/CN
  • 16 The First Affiliated Hospital of Anhui Medical University, Hefei/CN
  • 17 Jinan Central Hospital Affiliated to Shandong University, Jinan/CN
  • 18 Jiangxi Cancer Hospital, Nanchang/CN


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Abstract 7MO


Oritinib (SH-1028) is a third-generation EGFR-TKI selectively targeting both sensitive EGFR and EGFR T790M mutations. Herein, we report the efficacy and safety of oritinib in EGFR T790M-positive advanced NSCLC patients from the phase II study (NCT03823807).


Eligible patients were locally advanced or metastatic NSCLC patients aged ≥ 18 years, with centrally confirmed EGFR T790M mutation. Patients with asymptomatic, stable CNS metastases were eligible into the study. Oritinib 200 mg was given orally once daily until disease progression or unacceptable toxicity. Primary efficacy endpoint was objective response rate (ORR). Secondary efficacy endpoints included disease control rate (DCR), progression-free survival (PFS), duration of response (DOR) and overall survival (OS).


Between December 2019 and March 2021, 228 patients were enrolled and 227 patients received at least one dose of oritinib. The median age of 227 patients was 62 years old, 57.3% of patients were female and 24.7% received systemic chemotherapies. At data cutoff (September 17, 2021), 137 of 227 patients achieved confirmed partial responses with ORR of 60.4% (95% CI: 42.4%, 68.8%) by IRaC. The DCR was 92.5% (88.3%, 95.6%), the mPFS was 12.6 months (95% CI: 9.7, 15.3), the mDOR was 12.5 months (95% CI: 11.2, NA) and the mOS was immature. The most common (≥10%) treatment-emergent adverse events (TEAEs) included diarrhea (45.4%), increased blood creatine phosphokinase (26.0%), anaemia (20.3%), decreased white blood cell count (15.4%), decreased appetite (15.0%), increased blood creatine phosphokinase isoenzyme (13.2%), nausea (13.2%), vomiting (13.2%), increased serum creatine (12.8%), upper respiratory tract infection (12.3%), increased aspartate aminotransferase (11.9%), cough(11.9%), decreased platelet count (11.0%), constipation (10.6%). Grade≥3 TEAEs included increased blood creatine phosphokinase (4.0%), hypertension (3.1%), death (2.6%), diarrhea (2.2%). No interstitial lung disease were reported.


Oritinib demonstrated potential clinical benefit and tolerable in advanced NSCLC patients with EGFR T790M mutation.

Clinical trial identification

NCT03823807; January 30, 2019.

Legal entity responsible for the study

NanJing Sanhome Pharmaceutical Co., Ltd.


NanJing Sanhome Pharmaceutical Co., Ltd.


All authors have declared no conflicts of interest.

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