Amgen Inc AMGN on Monday released data from the Phase 3 FORTITUDE-101 trial of first-line bemarituzumab plus chemotherapy (mFOLFOX6).
The study 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 for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and who are non-HER2 positive.
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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.
The most common treatment-emergent adverse events (>25%) in patients treated with bemarituzumab plus chemotherapy were reduced visual acuity, punctate keratitis, anemia, 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 ZLAB. 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 the second half of 2025.
Commenting on the Phase 3 results, William Blair stated, “We look forward to the detailed update to understand the survival benefit seen with bemarituzumab as well as the safety profile.”
Analyst Matt Phipps emphasized that the rates of ocular adverse events (AEs) and subsequent discontinuation of bemarituzumab will be critical data points for assessing the drug’s market potential.
He reiterated optimism for MariTide, stating, “We still see a differentiated product profile for MariTide versus currently approved GLP-1 therapies or those in late-stage development, and therefore potential for meaningful market share and a multibillion-dollar peak sales opportunity.”
Despite this, Amgen is navigating immediate challenges stemming from its established product portfolio and difficulties in expanding market share within its biosimilar franchises.
However, William Blair anticipates that upcoming clinical milestones within the next 6 to 12 months will generate significant investor enthusiasm regarding Amgen’s long-term growth trajectory. Consequently, the firm has maintained its Outperform rating for the company.
Price Action: AMGN stock is up 0.40% at $278.23 at the last check on Monday.
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