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Amgen (AMGN) announced on Monday that a late-stage study evaluating its Bemarituzumab in combination with chemotherapy met its primary endpoint of improving overall survival.
Bemarituzumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival as compared to placebo plus chemotherapy in people living with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer with FGFR2b overexpression and cancer cells without high levels of the HER2 protein.
The FGFR2b protein is an emerging biomarker that, when overexpressed, can lead to tumor cell proliferation. It is overexpressed by gastric or gastroesophageal junction tumor cells in approximately 38% of patients with advanced cancers, the company said.
The most common treatment-emergent adverse events of the combination treatment expressed in over 25% of patients treated with Bemarituzumab plus chemotherapy were reduced visual acuity, punctate keratitis, anaemia, neutropenia, nausea, corneal epithelium defect, and dry eye, the company said.
According to Amgen, gastric cancer is the fifth leading cause of cancer-related deaths worldwide, with nearly a million new cases and over 650,000 deaths globally each year.
The late-stage study was conducted with the support of Zai Lab, a biopharmaceutical company based in China and the U.S. Zai Lab holds co-development and commercialization rights for Bemarituzumab for mainland China, Hong Kong, Macau, and Taiwan.
A late-stage study of Bemarituzumab plus chemotherapy and Nivolumab is also ongoing in patients with first-line gastric cancer, with data anticipated in the second half of this year, the company said.
On Stocktwits, retail sentiment around AMGN fell from ‘bullish’ to ‘neutral’ territory over the past 24 hours while message volume remained at ‘high’ levels.
AMGN stock is up approximately 7% this year and down about 11% over the past 12 months.
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