Expert Interview
Reviewing the Phase 3 FORTITUDE-101 Results for Bemarituzumab in FGFR2b+ First-Line Gastric and GEJ Cancer
Ticker(s): AMGNAn oncologist or gastrointestinal cancer specialist with experience in targeted therapies and biomarker-driven oncology trials. The expert should be familiar with FGFR signaling, clinical development pathways in upper GI malignancies, and the evolving role of first-line treatments in gastric cancer, especially for non-HER2 patient populations.
The FORTITUDE-101 study showed statistically significant and clinically meaningful overall survival improvement with bemarituzumab plus chemotherapy in FGFR2b+ gastric/GEJ cancer. How does this OS benefit compare with current first-line standards for non-HER2 patients, and what does it signal about the role of FGFR2b targeting in this setting?
Added By: slingshot_insightsFGFR2b overexpression was used to select eligible patients (≥10% of tumor cells with 2+/3+ IHC staining). How robust is this biomarker selection in ensuring treatment benefit, and could it become a standard pre-treatment diagnostic in gastric and GEJ cancers?
Added By: slingshot_insightsVisual disturbances and corneal toxicities were among the most common adverse events reported in the bemarituzumab arm. Given their frequency and severity, how manageable are these side effects in real-world clinical settings, and what kinds of monitoring or mitigation strategies might be necessary?
Added By: slingshot_insightsBemarituzumab was tested alongside mFOLFOX6 in the FORTITUDE-101 trial. How important is the choice of chemotherapy backbone in realizing the drug’s benefit, and could this combination be generalized to other platinum-based doublets?
Added By: slingshot_insightsPatients in FORTITUDE-101 were HER2-negative. How does bemarituzumab’s efficacy in FGFR2b+ patients reshape the treatment algorithm for HER2-negative gastric cancers, and is there potential for overlap or sequencing between FGFR2b and HER2-targeted approaches?
Added By: slingshot_insightsWith 547 patients enrolled across 37 countries, the FORTITUDE-101 study represents a large and diverse dataset. How important is this level of global trial representation for regulatory bodies and eventual clinical adoption, particularly in Asia where gastric cancer is more prevalent?
Added By: slingshot_insightsGiven the targeted nature of bemarituzumab and its reliance on IHC-defined FGFR2b overexpression, what are the hurdles or considerations regulators may evaluate regarding the companion diagnostic, and how could this impact the rollout timeline?
Added By: slingshot_insightsA separate Phase 3 trial is underway assessing bemarituzumab with chemotherapy and nivolumab. Based on current data, what is the scientific rationale for combining FGFR2b inhibition with checkpoint blockade, and what kind of synergy might we expect in FGFR2b+ tumors?
Added By: slingshot_insightsAre You Interested In These Questions?
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