Key Takeaways
- Bemarituzumab Shows Survival Benefit: The Phase III FORTITUDE-101 trial met its primary endpoint, with bemarituzumab plus chemotherapy significantly improving overall survival in FGFR2b-positive, HER2-negative gastric and gastric or gastroesophageal junction (G/GEJ) cancer.
- Ocular Adverse Events (AEs) Noted: While generally consistent with earlier findings, ocular AEs—including visual changes and dry eye—were more frequent and severe in the bemarituzumab treatment arm.
- Gastric Cancer Remains Global Concern: Despite declining incidence in the United States, gastric cancer remains the fifth most common cancer worldwide, with East Asia accounting for a significant share of global cases.
Results from the Phase III FORTITUDE-101 trial showed Amgen’s bemarituzumab combined with chemotherapy (mFOLFOX6) significantly improved overall survival (OS) in patients with previously untreated unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer who are FGFR2b-positive and HER2-negative. According to the company, the therapy met its primary endpoint at a pre-specified interim analysis, demonstrating both statistical significance and clinical relevance.1
Could Bemarituzumab Become a New Standard for FGFR2b-Positive Gastric Cancer?
"Most patients with gastric cancer are diagnosed at an advanced stage, with poor prognosis, low survival rates and limited therapeutic options," said Jay Bradner, MD, EVP, research and development, Amgen, in a press release.
FORTITUDE-101 Trial Design and Endpoints
- The randomized, multi-center, double-blind, placebo-controlled FORTITUDE-101 trial (NCT05052801) evaluated the efficacy of bemarituzumab plus chemotherapy compared to placebo plus chemotherapy in 547 patients.
- Patients were randomly assigned to receive either an intravenous (IV) infusion of bemarituzumab plus mFOLFOX6, administered as a combination of oxaliplatin and leucovorin as IV infusions, or an IV placebo in combination with mFOLFOX6 administered the same way.
- The primary endpoint of the trial was OS in patients with FGFR2b ≥10% 2+/3+ tumor cell staining, while key secondary endpoints included progression-free survival and overall response rate.1,2
- Amgen stated that detailed efficacy and safety results from the trial will be presented at an upcoming medical meeting.
Safety Profile
- Common treatment-related adverse events associated with bemarituzumab plus chemotherapy included visual acuity changes, punctate keratitis, anemia, neutropenia, nausea, corneal epithelium defects, and dry eye.
- Although ocular events were observed in both treatment arms and were consistent with findings from the Phase II trial, they were more frequent and more severe in patients receiving bemarituzumab in the Phase III study.1
Epidemiology and Global Context
According to the American Cancer Society, it is estimated that there will be approximately 30,300 new cases of stomach cancer and 10,780 deaths by the end of 2025. It accounts for around 1.5% of all cancers diagnosed in the United States annually. Stomach cancer is most common in people over 65 years of age, who make up 60% of all cases. The median age at diagnosis is 68. It is more common in men, who have a one in 101 chance of developing stomach cancer, while women have a one in 155 chance.
