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    DRUG:

    bemarituzumab (AMG 552)

    i
    Other names: AMG-552, AMG 552, FPA144, FPA 144, FPA-144, AMG552
    Company:
    Amgen, ZAI Lab
    Drug class:
    FGFR2b inhibitor
    Related drugs:
    22d
    Precision Antibody Therapy in Gastric and Gastroesophageal Cancer: Targeting FGFR2b, CLDN18.2, and VEGFR2. (PubMed, Cells)
    This review examines the mechanisms, safety profiles, and clinical trial outcomes of three targeted agents-bemarituzumab, zolbetuximab, and ramucirumab-which inhibit tumor growth through the FGFR2b, CLDN18.2, and VEGFR2 pathways, respectively. We also compare traditional versus adaptive clinical trial designs, explore emerging challenges such as therapeutic resistance and treatment-related toxicities, and consider implications for personalized medicine. Collectively, these agents represent a paradigm shift from empiric chemotherapy toward biomarker-driven immunotherapy, with the potential to significantly improve survival and quality of life in patients with advanced G/GEJ cancers.
    Review • Journal • IO biomarker
    |
    CLDN18 (Claudin 18) • KDR (Kinase insert domain receptor)
    |
    Cyramza (ramucirumab) • Vyloy (zolbetuximab-clzb) • bemarituzumab (AMG 552)
    1m
    A single-arm, exploratory, phase II clinical trial of bemarituzumab combined with anlotinib, etoposide and carboplatin followed by thoracic radiotherapy as first-line treatment for extensive-stage small cell lung cancer. (ChiCTR2500110390)
    P2, N=39, Not yet recruiting, Affiliated Hospital of Guangdong Medical University; Affiliated Hospital of Guangdong Medical University
    New P2 trial
    |
    carboplatin • Focus V (anlotinib) • etoposide IV • bemarituzumab (AMG 552)
    2ms
    FORTITUDE-103: A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer. (clinicaltrials.gov)
    P1/2, N=72, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting | Trial completion date: Aug 2028 --> Mar 2028 | Trial primary completion date: Jun 2026 --> Jan 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    FGFR2 overexpression
    |
    Opdivo (nivolumab) • capecitabine • oxaliplatin • bemarituzumab (AMG 552)
    3ms
    ANGELICA: AssociatiNG Bevacizumab bEmarituzumab for GynecoLogIcal CAncer (clinicaltrials.gov)
    P1/2, N=87, Not yet recruiting, Centre Leon Berard
    New P1/2 trial
    |
    Avastin (bevacizumab) • bemarituzumab (AMG 552)
    4ms
    A Phase II Clinical Trial Evaluating the Efficacy and Safety of Bemarituzumab in Combination with Anlotinib as Consolidation Therapy in Limited-Stage Small Cell Lung Cancer (LS-SCLC) Patients Without Progression After Definitive Treatment (L-STAR Study) (ChiCTR2500106624)
    P2, N=35, Not yet recruiting, Shandong First Medical University Affiliated Cancer Hospital; Shandong First Medical University Affiliated Cancer Hospital
    New P2 trial
    |
    Focus V (anlotinib) • bemarituzumab (AMG 552)
    4ms
    FORTITUDE-301: A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (clinicaltrials.gov)
    P1/2, N=260, Active, not recruiting, Amgen | Trial completion date: Sep 2027 --> Feb 2026
    Trial completion date • Pan tumor
    |
    bemarituzumab (AMG 552)
    4ms
    FORTITUDE-101: Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (clinicaltrials.gov)
    P3, N=547, Active, not recruiting, Amgen | Trial completion date: Aug 2025 --> Jun 2026
    Trial completion date
    |
    FGFR2 (Fibroblast growth factor receptor 2)
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • bemarituzumab (AMG 552)
    4ms
    FORTITUDE-103: A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer. (clinicaltrials.gov)
    P1/2, N=70, Recruiting, Amgen | Trial completion date: Apr 2028 --> Aug 2028 | Trial primary completion date: Mar 2026 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • capecitabine • oxaliplatin • bemarituzumab (AMG 552)
    5ms
    FGFR2b protein overexpression: An emerging biomarker in gastric and gastroesophageal junction adenocarcinoma. (PubMed, Cancer Treat Rev)
    Fibroblast growth factor receptor 2 isoform IIIb (FGFR2b) is an emerging biomarker under phase 3 clinical investigation for G/GEJC with the novel monoclonal antibody bemarituzumab. FGFR2b protein overexpression in gastric cancer, together with its function in various oncogenic signaling pathways, makes it an attractive target for precision medicine and thereby has gained clinical interest for its potential prognostic role in G/GEJC. Thus, to explore the potential role of FGFR2b, this narrative review summarizes the role and mechanism of FGFR2b in advanced G/GEJC, describes appropriate detection methodology for FGFR2b protein overexpression, and discusses future considerations for precision treatment in advanced G/GEJC with respect to FGFR2b protein overexpression and the emergence of other biomarkers.
    Review • Journal
    |
    FGFR2 (Fibroblast growth factor receptor 2)
    |
    bemarituzumab (AMG 552)
    6ms
    Clinical characterization of FGFR2b expression in patients with advanced gastric or gastroesophageal junction adenocarcinoma. (PubMed, ESMO Open)
    This study revealed limited overlap of FGFR2b overexpression with currently actionable biomarkers, suggesting FGFR2b is a novel biomarker that identifies a distinct GC/GEJC patient population who may benefit most from an FGFR2b-targeting therapy.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • FGFR2 (Fibroblast growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    HER-2 negative • HER-2 negative + FGFR2b overexpression
    |
    bemarituzumab (AMG 552)
    6ms
    FORTITUDE-102: Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer. (clinicaltrials.gov)
    P3, N=515, Active, not recruiting, Amgen | Trial completion date: Sep 2026 --> Jan 2027 | Trial primary completion date: Sep 2026 --> Jan 2026
    Trial completion date • Trial primary completion date
    |
    FGFR2 (Fibroblast growth factor receptor 2)
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • bemarituzumab (AMG 552)
    7ms
    NeoBEMA: Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment (clinicaltrials.gov)
    P1, N=27, Not yet recruiting, European Organisation for Research and Treatment of Cancer - EORTC
    New P1 trial
    |
    docetaxel • oxaliplatin • bemarituzumab (AMG 552)