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    DRUG CLASS:

    FGFR2b inhibitor

    Related drugs:
    10d
    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, Not yet recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
    New P2 trial • Metastases
    |
    paclitaxel • Cyramza (ramucirumab) • irinotecan • Lonsurf (trifluridine/tipiracil) • bemarituzumab (AMG 552)
    21d
    A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201) (clinicaltrials.gov)
    P1, N=74, Terminated, Amgen | Completed --> Terminated; Business decision not due to safety concerns
    Trial termination
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    KRAS (KRAS proto-oncogene GTPase) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • KRAS G12C • KRAS G12 • FGFR2 overexpression • FGFR2b overexpression
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    Keytruda (pembrolizumab) • carboplatin • docetaxel • albumin-bound paclitaxel • 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=80, Recruiting, Amgen | Phase classification: P1 --> P1/2
    Phase classification
    |
    FGFR2 overexpression • FGFR2b overexpression
    |
    Opdivo (nivolumab) • capecitabine • oxaliplatin • bemarituzumab (AMG 552)
    5ms
    FORTITUDE-101: Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (clinicaltrials.gov)
    P3, N=516, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    FGFR2 (Fibroblast growth factor receptor 2)
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • bemarituzumab (AMG 552)
    5ms
    A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201) (clinicaltrials.gov)
    P1, N=74, Completed, Amgen | Active, not recruiting --> Completed | N=180 --> 74
    Trial completion • Enrollment change
    |
    KRAS (KRAS proto-oncogene GTPase) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    Keytruda (pembrolizumab) • carboplatin • docetaxel • albumin-bound paclitaxel • bemarituzumab (AMG 552)
    5ms
    Bemarituzumab plus mFOLFOX6 as first-line treatment in East Asian patients with FGFR2b-overexpressing locally advanced or metastatic gastric/gastroesophageal junction cancer: subgroup of FIGHT final analysis. (PubMed, Gastric Cancer)
    In East Asian patients with FGFR2b-positive advanced/metastatic G/GEJC enrolled in the global FIGHT study, bemarituzumab-mFOLFOX6 showed clinically meaningful outcomes over placebo-mFOLFOX6.
    Journal • Metastases
    |
    FGFR2 (Fibroblast growth factor receptor 2)
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • bemarituzumab (AMG 552)
    6ms
    A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201) (clinicaltrials.gov)
    P1, N=180, Active, not recruiting, Amgen | Phase classification: P1b --> P1
    Phase classification
    |
    KRAS (KRAS proto-oncogene GTPase) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • KRAS G12C • KRAS G12 • FGFR2 overexpression • FGFR2b overexpression
    |
    Keytruda (pembrolizumab) • carboplatin • docetaxel • albumin-bound paclitaxel • bemarituzumab (AMG 552)
    7ms
    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, N=80, Recruiting, Amgen | Trial primary completion date: Nov 2026 --> Mar 2026
    Trial primary completion date • Combination therapy • Metastases
    |
    FGFR2 overexpression • FGFR2b overexpression
    |
    Opdivo (nivolumab) • capecitabine • oxaliplatin • bemarituzumab (AMG 552)
    7ms
    New therapeutic target molecules for gastric and gastroesophageal junction cancer. (PubMed, Int J Clin Oncol)
    Phase III and Ib/III trials of the FGFR2-targeted antibody bemarituzumab for G/GEJ cancer overexpressing FGFR2b are ongoing based on the promising result in a phase II trial, especially in cases with an FGFR2b positivity of ≥ 10%...CLDN18.2 is expressed in some G/GEJ tumors but lacks oncogenic driver potential, and the CLDN18.2-targeted antibody zolbetuximab prolonged the survival of CLDN18.2-positive G/GEJ cancer patients in phase III trials...Similarly, targeting of nondriver molecules such as DKK1, TROP2, and CEACAM5 is under investigation in early-stage clinical trials. This shift in focus from target molecules with driver potential to markers for precise drug delivery should increase the number of possible targets in G/GEJ cancer.
    Review • Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • FGFR2 (Fibroblast growth factor receptor 2) • CLDN18 (Claudin 18) • CEACAM5 (CEA Cell Adhesion Molecule 5) • DKK1 (dickkopf WNT signaling pathway inhibitor 1)
    |
    FGFR2 amplification • CLDN18.2 positive • FGFR2 overexpression • FGFR2b overexpression
    |
    Vyloy (zolbetuximab-clzb) • bemarituzumab (AMG 552)
    8ms
    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, N=80, Recruiting, Amgen | Trial completion date: Sep 2027 --> Apr 2028 | Trial primary completion date: May 2026 --> Nov 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    FGFR2 overexpression • FGFR2b overexpression
    |
    Opdivo (nivolumab) • capecitabine • oxaliplatin • bemarituzumab (AMG 552)
    8ms
    Targeted Agents in Esophagogastric Cancer Beyond Human Epidermal Growth Factor Receptor-2. (PubMed, Hematol Oncol Clin North Am)
    Other targeted agents, such as bemarituzumab and DKN-01, are under active investigation. As new agents are incorporated into the treatment continuum, the questions of biomarker overlap, tumor heterogeneity, and toxicity management will need to be addressed.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    sirexatamab (DKN-01) • bemarituzumab (AMG 552)
    9ms
    FORTITUDE-301: A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (clinicaltrials.gov)
    P1/2, N=303, Recruiting, Amgen | Trial completion date: Jul 2026 --> Jun 2027 | Trial primary completion date: Oct 2024 --> Sep 2025
    Trial completion date • Trial primary completion date • Pan tumor
    |
    FGFR2 overexpression • FGFR2b overexpression
    |
    bemarituzumab (AMG 552)
    10ms
    Bemarituzumab as first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma: final analysis of the randomized phase 2 FIGHT trial. (PubMed, Gastric Cancer)
    In FGFR2b-positive advanced GC, the combination of bemarituzumab-mFOLFOX6 led to numerically longer median PFS and OS compared with mFOLFOX6 alone. Efficacy was more pronounced with FGFR2b overexpression in ≥ 10% of tumor cells. Confirmatory phase 3 trials are ongoing (NCT05052801, NCT05111626).
    P2 data • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • FGFR2 (Fibroblast growth factor receptor 2)
    |
    HER-2 negative • FGFR2 overexpression • FGFR2b overexpression • FGFR2b positive
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • bemarituzumab (AMG 552)
    11ms
    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, N=80, Recruiting, Amgen | Phase classification: P1b --> P1 | N=30 --> 80
    Phase classification • Enrollment change • Combination therapy • Metastases
    |
    FGFR2 overexpression • FGFR2b overexpression
    |
    Opdivo (nivolumab) • capecitabine • oxaliplatin • bemarituzumab (AMG 552)