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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:
    14d
    FORTITUDE-101: Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (clinicaltrials.gov)
    P3, N=547, Completed, Amgen | Active, not recruiting --> Completed
    Trial completion
    |
    FGFR2 (Fibroblast growth factor receptor 2)
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • bemarituzumab (AMG 552)
    16d
    Global prevalence of FGFR2b protein overexpression in advanced gastric cancer and gastroesophageal junction cancers: pooled analysis of two bemarituzumab phase III studies. (PubMed, ESMO Open)
    This study represents the largest prevalence assessment of FGFR2b overexpression in G/GEJC using a validated IHC assay. The observed estimates of 36.5% (any 2+/3+) and 16.6% (FGFR2b ≥10% 2+/3+) suggest that FGFR2b is prevalent in a meaningful proportion of patients with advanced G/GEJC.
    P3 data • Retrospective data • Journal
    |
    FGFR2 (Fibroblast growth factor receptor 2)
    |
    FGFR2 overexpression
    |
    bemarituzumab (AMG 552)
    25d
    Bemarituzumab Suppresses Choroidal Neovascularization in Mice by Downregulating Melanoma Cell Adhesion Molecule and Yes-Associated Protein 1. (PubMed, ACS Pharmacol Transl Sci)
    Experiments on HUVECs further verify the inhibitory effect of FPA144 on vascular endothelial cells. Our findings demonstrate that FPA144 can efficiently inhibit the development of choroidal neovascularization in mice by downregulating CD146 and Yap1.
    Preclinical • Journal
    |
    YAP1 (Yes associated protein 1) • MCAM (Melanoma Cell Adhesion Molecule)
    |
    bemarituzumab (AMG 552)
    1m
    Carboplatin/Cisplatin + Etoposide + Benmelstobart Sequential Benmelstobart Combined With Anlotinib Versus Carboplatin/Cisplatin + Etoposide + Tislelizumab Sequential Tislelizumab in the Treatment of Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=40, Terminated, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=134 --> 40 | Trial completion date: Apr 2027 --> Apr 2026 | Recruiting --> Terminated | Trial primary completion date: Oct 2026 --> Apr 2026; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    cisplatin • carboplatin • Focus V (anlotinib) • Tevimbra (tislelizumab-jsgr) • etoposide IV • Andewei (benmelstobart) • bemarituzumab (AMG 552)
    2ms
    ANGELICA: AssociatiNG Bevacizumab bEmarituzumab for GynecoLogIcal CAncer (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, Centre Leon Berard | N=87 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    FOLR1 ( Folate receptor alpha ) • BRCA (Breast cancer early onset)
    |
    MSI-H/dMMR • FOLR1 expression • FGFR2 overexpression • BRCA mutation
    |
    Avastin (bevacizumab) • bemarituzumab (AMG 552)
    2ms
    20210096: Study Comparing Bemarituzumab plus Chemotherapy with Placebo and Chemotherapy in Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer with FGFR2b Overexpression (FORTITUDE-101) (2023-505457-40-00)
    P2/3, N=327, Completed, Amgen Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • bemarituzumab (AMG 552)
    3ms
    SBRT Plus Anlotinib and Bimepolizumab in Locally Advanced or Metastatic Renal Cell Carcinoma (clinicaltrials.gov)
    P2, N=27, Not yet recruiting, Fujian Cancer Hospital
    New P2 trial
    |
    Focus V (anlotinib) • bemarituzumab (AMG 552)
    4ms
    WJOG18524G: a single-arm phase II study evaluating bemarituzumab combined with ramucirumab and paclitaxel in fibroblast growth factor receptor 2b (FGFR2b)-positive advanced gastric or gastroesophageal junction cancer (RAINBIRD). (PubMed, ESMO Gastrointest Oncol)
    The primary endpoint is the objective response rate, which is assessed by a blinded independent central review. Translational research is planned to explore the predictive biomarkers and mechanisms of resistance to bemarituzumab by sequencing tumor DNA (PleSSiSion-Neo) and circulating tumor DNA (Guardant360), which are collected at multiple time points.
    P2 data • Journal
    |
    FGFR2 (Fibroblast growth factor receptor 2)
    |
    FGFR2 overexpression
    |
    Guardant360® CDx
    |
    paclitaxel • Cyramza (ramucirumab) • 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, Completed, Amgen | Active, not recruiting --> Completed
    Trial completion • Pan tumor
    |
    FGFR2 overexpression
    |
    bemarituzumab (AMG 552)
    5ms
    BEMAFLOT: Study Evaluating the Combination of Bemarituzumab + FLOT Chemotherapy in Perioperative Setting for Resectable Stage cT2-T4a or N+ Gastric and GEJ Adenocarcinoma Overexpressing FGFR2b (clinicaltrials.gov)
    P2, N=0, Withdrawn, Institut Cancerologie de l'Ouest | N=49 --> 0 | Trial completion date: Jun 2034 --> Jan 2026 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jun 2029 --> Jan 2026
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date
    |
    FGFR2 overexpression
    |
    docetaxel • oxaliplatin • bemarituzumab (AMG 552)
    5ms
    Bemarituzumab in FGFR2b+ Patients With Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction, Who Failed at Least One Prior Line of Palliative Chemotherapy (clinicaltrials.gov)
    P2, N=126, Active, not recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    paclitaxel • Cyramza (ramucirumab) • irinotecan • Lonsurf (trifluridine/tipiracil) • 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 primary completion date: Jan 2026 --> Oct 2025
    Trial primary completion date
    |
    FGFR2 (Fibroblast growth factor receptor 2)
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • bemarituzumab (AMG 552)