AMGEN ANNOUNCES POSITIVE TOPLINE PHASE 3 RESULTS FOR BEMARITUZUMAB IN FIBROBLAST GROWTH FACTOR RECEPTOR 2b (FGFR2b) POSITIVE FIRST-LINE GASTRIC CANCER

Rhea-AI Summary

Amgen (NASDAQ:AMGN) announced positive topline results from its Phase 3 FORTITUDE-101 clinical trial for bemarituzumab in gastric cancer treatment. The trial met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in overall survival (OS) when combining bemarituzumab with chemotherapy compared to placebo plus chemotherapy.

The study focused on patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and non-HER2 positive status. This breakthrough is particularly significant given that gastric cancer is the fifth leading cause of cancer-related death worldwide, with nearly one million new cases and over 650,000 deaths annually.

The most common treatment-emergent adverse events included reduced visual acuity, punctate keratitis, anemia, neutropenia, nausea, corneal epithelium defect, and dry eye. Notably, ocular events occurred with greater frequency and severity in the bemarituzumab arm compared to the Phase 2 experience. A separate Phase 3 study combining bemarituzumab with chemotherapy and nivolumab is ongoing, with results expected in H2 2025.

Positive

• None.

Negative

• Increased frequency and severity of ocular adverse events compared to Phase 2
• Multiple significant adverse events reported in over 25% of treated patients

Insights

Oncology Research Specialist

Amgen's bemarituzumab significantly extends survival in advanced gastric cancer patients with FGFR2b overexpression, representing a breakthrough in targeted therapy.

The positive topline results from Amgen's Phase 3 FORTITUDE-101 trial represent a significant therapeutic breakthrough for gastric cancer treatment. The trial demonstrated that bemarituzumab plus chemotherapy (mFOLFOX6) achieved its primary endpoint of overall survival in patients with FGFR2b-overexpressing gastric or gastroesophageal junction cancers.

This is particularly noteworthy as gastric cancer remains the fifth leading cause of cancer-related death globally, with approximately 650,000 deaths annually. First-line treatment options for advanced gastric cancer have been limited, with poor prognosis and low survival rates being the norm.

The clinical significance here is substantial - bemarituzumab is the first FGFR2b-targeted monoclonal antibody to show positive Phase 3 results in gastric cancer. This targeted approach addresses a specific molecular pathway driving tumor growth in a subset of patients, representing the kind of precision medicine approach that has been largely absent in gastric cancer treatment.

The safety profile shows notable ocular adverse events including reduced visual acuity, punctate keratitis, corneal epithelium defect, and dry eye occurring with greater frequency and severity in the treatment arm compared to the control arm. This toxicity profile will be important to monitor and manage in clinical practice.

With a parallel Phase 3 study combining bemarituzumab with chemotherapy and nivolumab also underway (results expected in H2 2025), Amgen is building a comprehensive clinical program that could potentially establish this therapy as a new standard of care for FGFR2b-positive gastric cancer patients.

At an Interim Analysis, Bemarituzumab Plus Chemotherapy Significantly Improved Overall Survival in People With FGFR2b Overexpression Compared to Chemotherapy Alone

THOUSAND OAKS, Calif., June 30, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival (OS) at a pre-specified interim analysis. 

Bemarituzumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS as compared to placebo plus chemotherapy in people living with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and who are non-HER2 positive. FGFR2b overexpression was defined as 2+/3+ staining in ≥10% of tumor cells by centrally performed immunohistochemistry (IHC) testing.

Gastric cancer is the fifth leading cause of cancer-related death worldwide, with nearly one million new cases and over 650,000 deaths globally each year ¹, highlighting a critical unmet medical need.

"Most patients with gastric cancer are diagnosed at an advanced stage, with poor prognosis, low survival rates and limited therapeutic options," said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. "These first positive top-line results of an FGFR2b targeted monoclonal antibody from our Phase 3 FORTITUDE-101 study mark a meaningful advance in the development of effective targeted therapy for gastric cancer."

The most common treatment-emergent adverse events (>25%) in patients treated with bemarituzumab plus chemotherapy were reduced visual acuity, punctate keratitis, anaemia, neutropenia, nausea, corneal epithelium defect and dry eye. While ocular events were consistent with the Phase 2 experience and observed in both arms, they occurred with greater frequency and severity in the Phase 3 bemarituzumab arm.

Detailed results from the trial will be shared at a future medical meeting.

FORTITUDE-101 was conducted with the support of Zai Lab. Zai Lab holds co-development and commercialization rights for bemarituzumab for mainland China, Hong Kong, Macau, and Taiwan.

A Phase 3 study of bemarituzumab plus chemotherapy and nivolumab is also ongoing in patients with first-line gastric cancer, with a data readout anticipated in H2 2025.

About FGFR2b 
The FGFR2b protein (also known as fibroblast growth factor receptor 2b) is an emerging biomarker which, when overexpressed, promotes aberrant signaling leading to tumor cell proliferation.²

The FGFR2b protein is overexpressed by G/GEJ tumor cells in approximately 38% of patients with advanced G/GEJ cancer. FGFR2b protein overexpression is defined as 2+/3+ staining intensity on tumor cell membrane, as detected by immunohistochemistry (IHC) testing. In approximately 16% of patients with advanced G/GEJ cancer, FGFR2b protein overexpression is observed on ≥10% of tumor cells by IHC.³

About FORTITUDE-101 
FORTITUDE-101 is a randomized, multi-center, double-blind, placebo-controlled Phase 3 study of bemarituzumab plus mFOLFOX6 versus placebo plus mFOLFOX6 as first-line therapy in advanced G/GEJ cancer with FGFR2b overexpression. The FORTITUDE-101 trial spanned 300 sites across 37 countries, with 547 patients enrolled.

The primary outcome measure of the trial is overall survival in patients with FGFR2b ≥10% 2+/3+ tumor cell staining.  Key secondary outcome measures include progression-free survival and overall response rate. Candidates were excluded from the trial if they were known to be human epidermal growth factor receptor 2 (HER2) positive. FORTITUDE-101 included more comprehensive ocular-related monitoring than previous studies of bemarituzumab.

About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.

In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average^®, and it is also part of the Nasdaq-100 Index^®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.

For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram,  YouTube and Threads. 

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CONTACT: Amgen, Thousand Oaks
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REFERENCES

1. Bray F, et al. CA Cancer J Clin. 2024;74(3);229-263
2. Wainberg ZA, et al. Lancet Oncol. 2022;23(11):1430-40
3. Rha SY, et al. JCO Precis Oncol. 2025; 9 (e2400710). DOI:10.1200/PO-24-00710

 

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FAQ

What were the Phase 3 trial results for Amgen's bemarituzumab (NASDAQ:AMGN) in gastric cancer?

The Phase 3 FORTITUDE-101 trial met its primary endpoint, showing statistically significant and clinically meaningful improvement in overall survival when combining bemarituzumab with chemotherapy versus placebo plus chemotherapy in FGFR2b-positive gastric cancer patients.

What are the side effects of Amgen's bemarituzumab treatment for gastric cancer?

The most common side effects (>25%) included reduced visual acuity, punctate keratitis, anemia, neutropenia, nausea, corneal epithelium defect, and dry eye. Ocular events occurred with greater frequency and severity in the Phase 3 bemarituzumab arm.

Which patients were included in Amgen's FORTITUDE-101 trial for bemarituzumab?

The trial included patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer with FGFR2b overexpression and non-HER2 positive status.

When will Amgen (NASDAQ:AMGN) release detailed results of the bemarituzumab Phase 3 trial?

Amgen stated that detailed results from the trial will be shared at a future medical meeting. Additionally, results from another Phase 3 study combining bemarituzumab with chemotherapy and nivolumab are expected in H2 2025.

What is the significance of bemarituzumab's trial results for gastric cancer treatment?

These are the first positive Phase 3 results of an FGFR2b targeted monoclonal antibody, representing a meaningful advance in targeted therapy for gastric cancer, which is the fifth leading cause of cancer-related death worldwide with 650,000+ annual deaths.