LianBio, a biotechnology company focused on delivering innovative medicines to patients across China and major Asian markets, has announced positive topline results from a Phase 2a trial evaluating the effectiveness of infigratinib in treating Chinese patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma. These promising results have led to the granting of Breakthrough Therapy Designation by the China National Medical Products Administration (NMPA) for infigratinib in the treatment of gastric cancer, offering new hope for patients in need.

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Phase 2a Trial

Evaluating Infigratinib's Potential:The Phase 2a trial conducted by LianBio was a multicenter, open-label, single-arm study designed to assess the safety and efficacy of infigratinib 125 mg QD in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification. The trial also included patients with advanced solid tumors exhibiting FGFR alterations who had received at least two prior lines of systemic therapy. The primary endpoint of the trial was the objective response rate (ORR), with secondary endpoints including duration of response, safety, disease control rate, progression-free survival, and overall survival.

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Promising Topline Results

The topline results from the gastric cancer and gastroesophageal junction adenocarcinoma cohort revealed a confirmed ORR of 25.0% among the patients involved. Additionally, the observed median duration of response (DOR) was 3.8 months. Notably, 57.1% of patients had received two prior lines of systemic therapy, indicating that infigratinib could potentially benefit patients who have exhausted existing treatment options. The most common treatment-emergent adverse events experienced by patients included hyperphosphatemia, anemia, liver enzyme increases, gastrointestinal issues, and blood count abnormalities.