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Mini Oral - NSCLC, metastatic

LBA56 - ORIENT-12: Sintilimab plus gemcitabine and platinum (GP) as first-line (1L) treatment for locally advanced or metastatic squamous non-small-cell lung cancer (sqNSCLC)


18 Sep 2020


Mini Oral - NSCLC, metastatic


Cytotoxic Therapy;  Immunotherapy

Tumour Site

Non-Small Cell Lung Cancer


Caicun Zhou


Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325


C. Zhou1, L. Wu2, Y. Fan3, Z. Wang4, L. Liu5, G. Chen6, L. Zhang7, D. Huang8, S. Cang9, Z. Yang10, J. Zhou11, C. Zhou12, B. Li13, J. Li14, M. Fan15, W. Zhang16, W. Yang16, S. Wang16, H. Zhou16

Author affiliations

  • 1 Oncology Department, Shanghai Pulmonary Hospital, 200433 - Shanghai/CN
  • 2 Department Of Thoracic Medical Oncology, Hunan Cancer Hospital(The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, 410006 - Changsha/CN
  • 3 Oncology Departmen, Zhe Jiang Cancer Hospital, 310000 - hangzhou/CN
  • 4 Internal Medicine, Shandong Province Cancer Hospital, 250000 - Jinan/CN
  • 5 Oncology Department, Jiangsu Province Hospital, 210000 - Nanjing/CN
  • 6 Respiratory Ward 1, Harbin Medical University Cancer Hospital, 150081 - Harbin/CN
  • 7 Department Of Respiration, Peking Union Medical College Hospital, 100032 - Beijing/CN
  • 8 Department Of Thoracic Oncology, Tianjin Medical University Cancer Insititute and Hospital, 300060 - Tianjin/CN
  • 9 Oncology Departmeng, Henan Provincial Peoples Hospital, 450003 - Zhengzhou/CN
  • 10 Oncology Department, Affiliated Hospital of Guangdong Medical University, 524002 - Zanjiang/CN
  • 11 Respiratory Medicine, The First Affiliated hospital, Zhejiang University, 310000 - hangzhou/CN
  • 12 Oncology Department, The First Affiliated Hospital of GuangZhou Medical University, 510030 - Guangzhou/CN
  • 13 General Department, Beijing Chest Hospital ,Capital Medical University, 101149 - Beijing/CN
  • 14 Medical Oncology, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Cancer Hospital affiliate to School of Medicine, 610041 - Chengdu/CN
  • 15 Radiology Department, Fudan University Shanghai Cancer Center, 200032 - Shanghai/CN
  • 16 Oncology, Innovent Biologics, Inc., 200050 - Shanghai/CN


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Abstract LBA56


Sintilimab, an anti-PD-1 antibody, plus GP showed promising efficacy and acceptable safety in 1L sqNSCLC in a phase Ib study. ORIENT-12, a randomized, double-blind, phase III study, compared the efficacy and safety of sintilimab plus GP with placebo plus GP as 1L treatment for patients with locally advanced or metastatic sqNSCLC (NCT03629925).


Patients with histologically/cytologically confirmed stage IIIB/C (ineligible for concurrent chemoradiation or surgery) and stage IV sqNSCLC were enrolled and randomized 1:1 to receive either sintilimab (S group) or placebo (P group) with GP every 3 weeks for 4 or 6 cycles, followed by sintilimab or placebo as maintenance therapy. Stratification factors included disease stage (IIIB/C vs IV), platinum (cisplatin vs. carboplatin), PD-L1 expression (TPS, ≥1% vs <1%). Conditional crossover was allowed. The primary endpoint was progression-free survival (PFS) assessed by Independent Radiographic Review Committee (IRRC) per RECIST v1.1.


A total of 357 pts were enrolled and randomized to S group (n=179) and P group (n=178). At interim analysis (median follow-up 8.0 mon), mPFS (by IRRC) was 5.1 mo in S group vs 4.9 mo in P group (HR, 0.621; 95% CI 0.473 - 0.815; P=0.00056). mPFS benefit was also observed by investigator assessment (5.9 mo vs. 4.9 mo, HR, 0.575; 95%CI 0.435 - 0.761; P=0.00009). The mOS was not reached in both groups, but showed a nominally significant improvement favoring S group (HR, 0.567, 95%CI, 0.353 to 0.909, P=0.01701). The PFS benefit with sintilimab plus GP was observed in all PD-L1 subgroups. The incidence of grade ≥3 adverse events was similar between groups (86.6% vs 83.1%). No new safety signals were observed.


ORIENT-12 is the first study globally to demonstrate superiority of an anti-PD-1 antibody plus GP over GP in PFS and OS with acceptable safety profile as 1L treatment for locally advanced or metastatic sqNSCLC.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

Innovent Biologics, Inc.


Innovent Biologics, Inc. and Eli Lilly and Company.


W. Zhang, W. Yang, S. Wang, H. Zhou: Full/Part-time employment: Innovent Biologics, Inc. All other authors have declared no conflicts of interest.

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