Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster session 21

1527P - Efficacy and safety of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma patients with FGFR2 gene amplification

Date

21 Oct 2023

Session

Poster session 21

Topics

Tumour Site

Gastric Cancer;  Gastro-Oesophageal Junction Cancer

Presenters

Jiajia Yuan

Citation

Annals of Oncology (2023) 34 (suppl_2): S852-S886. 10.1016/S0923-7534(23)01930-0

Authors

J. Yuan1, L. Shen1, T. Liu2, H. Xu3, J. Yang4, J. Wei5, H. Jiang6, Y. Deng7, Y. Wang8, X. Zhang1, J. Gong1, C. Lyu9, Y. Li10, L. Song9

Author affiliations

  • 1 Gi Oncology Department, Peking University Cancer Hospital and Institute, 100142 - Beijing/CN
  • 2 Medical Oncology Department, Zhongshan Hospital Affiliated to Fudan University, 200032 - Shanghai/CN
  • 3 Oncology Department, Hubei Cancer Hospital, 430072 - Wuhan/CN
  • 4 Clinical Oncology, Fujian Provincial Hospital, 350001 - Fuzhou/CN
  • 5 Oncology Department, The Affiliated Drum Tower Hospital of Nanjing University Medical School, 210008 - Nanjing/CN
  • 6 Medicine Department, The First Affiliated Hospital of Medical School of Zhejiang University, 310003 - Hangzhou/CN
  • 7 Clinical Oncology, The Sixth Affiliated Hospital, Sun Yat-sen University, 510655 - Guangzhou/CN
  • 8 Gastroenterology Ward One Department, Shanxi Cancer Hospital, 030013 - Taiyuan/CN
  • 9 Cotd, LianBio Development Co., Ltd. Shanghai, 200000 - Shanghai/CN
  • 10 Cotd, LianBio Development Co., Ltd. Shanghai, Shanghai/CN

Resources

Login to get immediate access to this content.

If you do not have an ESMO account, please create one for free.

Abstract 1527P

Background

The FGFR/FGF cascade is a complex intracellular pathway that controls cellular proliferation, tumor growth, angiogenesis, and dissemination. It is implicated in various human cancers including gastric cancer (GC). The FGFR2-amplification in a proportion ranging from 9% to 1.2% worldwide in GC patients. However, previous studies have demonstrated FGFR2-amplification may have poor PFS and OS survival in GC patients. Infigratinib (BGJ398) is a selective ATP-competitive, FGFR1–3 selective oral TKI. We present the data generated from the LB1001-201 trial (NCT05019794) Cohort 1 to evaluate the efficacy and safety of infigratinib monotherapy in previously systemic second-line treated patients harbouring FGFR2 gene amplification.

Methods

Population and eligibility criteria - Failed on prior 2nd -lines treatment or above, locally advanced or metastatic GC/EGJ. FGFR2 gene amplification positive was confirmed via central FISH testing. Adequate organ function and laboratory values. MAPK-MEK or selective FGFR inhibitor treatment-naive. Procedures and treatment - Tumor biopsy or FFPE samples will be tested at the central lab for FGFR2 gene amplification orally infigratinib (125mg, QD) for 3 weeks on, 1 week off in each 28-day cycle; Dose adjustment will be based on drug-related AEs and severity per protocol demanded. Outcomes and assessments - ORR and DCR: Descriptive statistics were used, and an accurate 95% CI was provided. Time-to-event endpoints were summarized using K-M analyses. Safety endpoints were analyzed using frequency and percentage distribution in patients who received at least one dose of infigratinib.

Results

cORR 25.0% (95%CI 8.7, 49.1), DCR 80.0% (95%CI 56.3, 94.3), mDoR 3.8 months (mos) (3.6, NE). mPFS 3.3 mos (95%CI 2.3, 4.5), mOS 8.0 mos (95%CI 4.1, NE). 15/19 patients with tumor shrinkage, the maximum from baseline was -78.5%. ≥ Grade 3 TRAE was 42.9%, most were recoverable. No drug-induced death was reported.

Conclusions

Infigratinib in GC/GEJ patients with FGFR2 gene amplification has shown an inspiring clinical improvement, with acceptable tolerance, which is a potential first TKI regimen that precisely targeting in this population.

Clinical trial identification

NCT05019794.

Editorial acknowledgement

Legal entity responsible for the study

Shanghai LianBio Development Co., Ltd.

Funding

Shanghai LianBio Development Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.