LianBio has reported positive topline results from a Phase IIa trial of infigratinib for the treatment of locally advanced or metastatic gastric cancer, or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification.

The proof of concept, single-arm, multicentre, open-label study has evaluated the efficacy and safety of 125mg infigratinib once a day (QD) in Chinese patients.

Patients with advanced solid tumours who are having FGFR alterations and who were previously treated with at least two systemic therapies have been enrolled in the study.

The objective response rate (ORR) is the primary endpoint while overall survival, disease control rate, duration of response, safety, and progression-free survival are secondary endpoints of the study.

An ORR of 25% was observed in the gastroesophageal junction adenocarcinoma and gastric cancer treated group.

The observed median duration of response (DOR) of 3.8 months was also demonstrated during the study period.

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LianBio CEO Yizhe Wang said: “The topline data from this proof-of-concept trial suggest infigratinib has the potential to provide meaningful clinical benefit in third-line or later gastric cancer.

“We look forward to further investigating the efficacy and safety of infigratinib in this patient population in a Phase II study designed to support registration in China that we plan to initiate next year.”

Based on the positive results, the China National Medical Products Administration has granted Breakthrough Therapy Designation to infigratinib for treating gastric cancer.

An orally administered, ATP-competitive, tyrosine kinase inhibitor of fibroblast growth factor receptor, Infigratinib demonstrated a meaningful rate of tumour shrinkage in clinical trials.