Reference Detail

Ref Type

Abstract

PMID

Authors

J. Yuan L. Shen T. Liu H. Xu J. Yang J. Wei H. Jiang Y. Deng Y. Wang X. Zhang J. Gong C. Lyu Y. Li L. Song

Title

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

Journal	Vol	Issue	Date	Pages	Journal Short Title
Annals of Oncology	34	Supplement 2	October 2023	S859-S860	Ann Oncol

URL

https://www.annalsofoncology.org/article/S0923-7534(23)02276-7/fulltext

Abstract Text

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.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
FGFR2 amp	stomach cancer	sensitive	Infigratinib	Phase II	Actionable	In a Phase II trial (LB1001-201), Truseltiq (infigratinib) treatment in patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 amplification resulted in a response rate of 25%, disease control rate of 80%, median duration of response of 3.8 months, median progression-free survival of 3.3 months, median overall survival of 8 months, with 15 of 19 patients experiencing tumor shrinkage (Ann Oncol 34 (2023): S761-S762; NCT05019794).	detail...