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Proffered Paper session: Thoracic cancers

LBA10 - A multicenter, randomized, double-blind, phase III study of gefitinib in combination with anlotinib or placebo in previously untreated patients with EGFR mutation-positive advanced non-small cell lung cancer (FL-ALTER)


02 Dec 2022


Proffered Paper session: Thoracic cancers


Clinical Research;  Targeted Therapy

Tumour Site

Non-Small Cell Lung Cancer


Wen Feng Fang


Annals of Oncology (2022) 33 (suppl_9): S1560-S1597. 10.1016/annonc/annonc1134


L. Zhang1, W.F. Fang2, Q. Yu3, H. Zhang4, G. Wu5, D. Wu6, Y. Lin7, J. Zhu8, J. Chen9, X. Hu10, B. Lan11, Z. Zhou12, H. Lin13, Z. Wang14, X. Lei15, S. Pan16, L. Chen17, J. Zhang18, T. Kong19, H. Yu20

Author affiliations

  • 1 Medical Oncology Dept., Sun Yat-sen University Cancer Center, 510060 - Guangzhou/CN
  • 2 Medical Oncology Dept., The First Affiliated Hospital of Sun Yat-Sen University, 510080 - Guangzhou/CN
  • 3 Respiratory Oncology Department, Affiliated Tumor Hospital of Guangxi Medical University, 530021 - Nanning/CN
  • 4 Medical Oncology Dept., The First People's Hospital Of Foshan, 528010 - Foshan/CN
  • 5 Medical Oncology Dept., Meizhou People's Hospital, 514000 - Meizhou/CN
  • 6 Respiratory Oncology Department, Shenzhen people’s Hospital, 518020 - Shenzhen/CN
  • 7 Medical Oncology Dept., Shantou University Medical College Cancer Hospital, 515041 - Shantou/CN
  • 8 Respiratory Oncology Department, Taizhou Central Hospital, 318000 - Taizhou/CN
  • 9 Chest Department, Hunan Provincial Cancer Hospital, 410013 - Changsha/CN
  • 10 Medical Oncology Dept., The First Affiliated Hospital of Guangxi Medical University, 530021 - Nanning/CN
  • 11 Chest Department, Shantou Central Hospital, 515031 - Shantou/CN
  • 12 Medical Oncology Dept., Shenzhen Second People's Hospital, 518036 - Shenzhen/CN
  • 13 Medical Oncology Dept., the Second Affiliated Hospital of Hainan Medical University, 570311 - Haikou/CN
  • 14 Immunotherapy Departmen, Henan Cancer Hospital/Affiliated Cancer Hospital of Zhengzhou University, 450008 - Zhengzhou/CN
  • 15 Medical Oncology Dept., Affiliated Hospital of Panzhihua University, 617099 - PanZhihua/CN
  • 16 Radiotherapy Department, Yuebei People's Hospital, 512025 - Shaoguan/CN
  • 17 Medical Oncology Dept., The First Affiliated Hospital of Shantou University Medical College, 515041 - Shantou/CN
  • 18 Medical Oncology Dept., Zhujiang Hospital of Southern Medical University, 501280 - Guangzhou/CN
  • 19 Internal Medicine - Oncology, 3rd Affiliated Hospital of ZhengZhou University, 450052 - Zhengzhou/CN
  • 20 Md, Shanghai OrigiMed Co., Ltd, 201112 - Shanghai/CN


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Abstract LBA10


Anlotinib(Catequentinib) is an oral multi-targeted tyrosine kinase inhibitor that effectively inhibits VEGFRs, FGFRs, PGFRs, c-kit and MET. This phase III study aims to evaluate the efficacy and safety of Anlotinib or placebo plus Gefitinib in patients (pts) with untreated EGFR-mutated metastatic NSCLC.


Eligible pts were aged 18∼75 years old, had stage IIIB or IV NSCLC, with an EGFR 19del or 21L858R mutation, an ECOG PS of 0 or 1, measurable lesion according to RECIST v1.1 and adequate organ function. We randomly assigned eligible pts in a 1:1 ratio to receive oral Gefitinib (250 mg QD) plus either Anlotinib (G+A group, 12 mg QD, days1-14, 21days per cycle) or matching placebo(G+P group) until progressive disease or unacceptable toxicity. The primary endpoint was PFS assessed by IRC. Secondary endpoints included OS、ORR、DCR、DoR and safety. Blood samples for ctDNA analysis were collected at baseline, first evaluation, and progression disease (PD) and analyzed with a 329-gene panel.


From Apr. 2019 to Aug. 2021, 315 patients were assigned to the G+A (n=157) or G+P group (n=158). At data cutoff (Jul 31, 2022), the median follow-up was 17.3m in G+A and 18.8m in G+P. The mPFS by IRC was significantly longer in G+A than in G+P group (14.75m vs. 11.20m; HR 0.64, p = 0.0035). Confirmed ORR was 76.13% in G+A and 64.52% in G+P. Treatment with G+A was associated with more durable response (mDoR: 12.48m vs 9.46m, HR=0.56, p=0.0003) than G+P. OS data are immature. Grade ≥3 TEAEs occurred in 49.68% (G+A) vs. 30.97% (G+P). The most common Grade ≥3 TEAEs were hypertension (29.68 %) in G+A and increased ALT (12.26%) in G+P. We also exploratory analysis biomarker information and resistance mechanism based on dynamic ctDNA. The preliminary analysis of the ctDNA data of 289 pts showed that pts with TP53+EGFR CNV co-mutations had a better benefit from G+A than G+P (11.74 m vs 6.83m; HR=0.3). We will update the detailed biomarker data in congress.


Compared with G+P group, G+A group significantly prolonged PFS in pts with untreated metastatic EGFR-mutated NSCLC and the safety profiles were manageable.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

The authors.


1) Chia Tai-Tianqing Pharmaceutical Co., Ltd. 2) OrigiMed.


All authors have declared no conflicts of interest.

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