Positive topline findings from the Phase 3 FORTITUDE-101 clinical trial for Amgen‘s (NASDAQ:AMGN) experimental medication, bemarituzumab, were reported today. At a predetermined interim analysis, the study’s primary aim of overall survival (OS) was achieved. It assessed the first-line treatment of gastric and gastroesophageal junction (G/GEJ) cancer that was positive for fibroblast growth factor receptor 2b (FGFR2b).
In comparison to placebo plus chemotherapy, the pivotal trial showed that bemarituzumab, when added to a standard chemotherapy regimen (mFOLFOX6), had a statistically significant and clinically relevant improvement in overall survival. The trial concentrated on FGFR2b overexpressing, HER2-negative patients with unresectable, locally progressed, or metastatic G/GEJ cancer.
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547 participants from 300 sites in 37 countries participated in the FORTITUDE-101 study, which was a randomized, multi-center, double-blind, placebo-controlled experiment. Overall survival in patients with at least 10% of tumor cells overexpressing FGFR2b was the main outcome. Overall response rate and progression-free survival were important secondary goals.
In the bemarituzumab arm of the research, the most frequent treatment-emergent adverse events were dry eye, punctate keratitis, anemia, neutropenia, nausea, decreased visual acuity, and corneal epithelial defect. Ocular events were more common and severe in the bemarituzumab group, but they were in line with earlier research.
For first-line gastric cancer, Amgen is also carrying out a Phase 3 research of bemarituzumab in conjunction with nivolumab and chemotherapy; findings are expected in the second half of 2025.
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In partnership with Zai Lab, bemarituzumab is being developed and marketed in Taiwan, Hong Kong, Macau, and mainland China. At a future medical symposium, the FORTITUDE-101 trial’s comprehensive results will be disclosed.
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