bemarituzumab (AMG 552) / Amgen 
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  • ||||||||||  Review, Journal, IO biomarker:  Targeted and combination immunotherapies using biologics for gastric cancer: the state-of-the-art. (Pubmed Central) -  Sep 24, 2024   
    Additionally, bemarituzumab, ananti-FGFR2b monoclonal antibody, has shown improvements in combination withchemotherapy in those with HER2 negative GAC with FGFR2 overexpression...Lastly, TROP-2 has emergedas an exciting solid tumor target and study is expected in GAC. All three ofthese therapeutic targets have seen an abundance of drug development in recentyears, and we anticipate newer targeted agents driving therapeutic decisions inGAC in the coming years.
  • ||||||||||  Vyloy (zolbetuximab) / Astellas, bemarituzumab (AMG 552) / Amgen
    Review, Journal:  New therapeutic target molecules for gastric and gastroesophageal junction cancer. (Pubmed Central) -  Aug 26, 2024   
    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.
  • ||||||||||  bemarituzumab (AMG 552) / Amgen
    SCR-A002, a novel FGFR2b-targeting antibody-drug-conjugate for solid tumors. () -  Apr 24, 2024 - Abstract #ASCO2024ASCO_4747;    
    Phase classification: P1b --> P1 SCR-A002 showed potent anti-tumor efficacy in preclinical data, which suggest that SCR-A002 is expected to provide a new treatment option as single agent or combo with SoC for patients with FGFR2b-overexpressing solid tumor.
  • ||||||||||  Review, Journal:  FGFR-targeted therapeutics: clinical activity, mechanisms of resistance and new directions. (Pubmed Central) -  Mar 25, 2024   
    The next generation of small-molecule inhibitors, such as lirafugratinib and LOXO-435, and the FGFR2-specific antibody bemarituzumab are expected to have a reduced risk of hyperphosphataemia and the ability to overcome certain resistance mutations. In this Review, we describe the development and current clinical role of FGFR inhibitors and provide perspective on future research directions including expansion of the therapeutic indications for use of FGFR inhibitors, combination of these agents with immune-checkpoint inhibitors and the application of novel technologies, such as artificial intelligence.
  • ||||||||||  Journal:  Advances in targeted therapy for gastric cancer based on tumor driver genes. (Pubmed Central) -  Mar 20, 2024   
    In addition, bemarituzumab targets overexpressed FGFR2, while zolbetuximab targets overexpressed CLDN18.2, significantly extending progression-free survival and overall survival in patients with gastric cancer in clinical trials. This article reviews the roles of tumor driver genes in the progression of gastric cancer; and the treatment strategies for gastric cancer based on targeting HER2, VEGF, FGFR2, CLDN18.2, MET and other tumor driver genes, aiming to provide reference for clinical application of targeted therapy for gastric cancer.
  • ||||||||||  bemarituzumab (AMG 552) / Amgen
    Trial completion date, Trial primary completion date, Monotherapy:  FORTITUDE-301: A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (clinicaltrials.gov) -  Mar 2, 2024   
    P1/2,  N=303, Recruiting, 
    This article reviews the roles of tumor driver genes in the progression of gastric cancer; and the treatment strategies for gastric cancer based on targeting HER2, VEGF, FGFR2, CLDN18.2, MET and other tumor driver genes, aiming to provide reference for clinical application of targeted therapy for gastric cancer. Trial completion date: Jul 2026 --> Jun 2027 | Trial primary completion date: Oct 2024 --> Sep 2025
  • ||||||||||  zolbetuximab (IMAB362) / Astellas, Cyramza (ramucirumab) / Eli Lilly, bemarituzumab (AMG 552) / Amgen
    MODULE 3: Therapeutic Options for Relapsed/Refractory GE Cancers; Novel Investigational Approaches (Hilton Chicago; Grand Ballroom (Level 2)) -  May 26, 2023 - Abstract #ASCO2023ASCO_7077;    
    This activity is supported by educational grants from Astellas, Bristol-Myers Squibb Company, Jazz Pharmaceuticals Inc, Lilly, and Novartis. Optimal integration of ramucirumab into the management of previously treated advanced gastric or GEJ cancer Ongoing investigation of novel ramucirumab-containing combination regimens Biological rationale for targeting claudin 18.2 in GE cancers; mechanism of action of zolbetuximab Design, eligibility criteria and available results from the Phase III SPOTLIGHT and GLOW trials evaluating zolbetuximab with chemotherapy as first-line therapy for advanced gastric or GEJ adenocarcinoma Potential clinical role of zolbetuximab and implications for biomarker assessment Mechanism of action of bemarituzumab; available efficacy and safety data with first-line bemarituzumab/chemotherapy for FGFR2b-positive metastatic gastric/GEJ cancer Mechanistic rationale for, published data with and ongoing evaluation of longitudinal assessment of circulating tumor DNA to monitor for recurrence and inform therapeutic decision-making after potentially curative treatment Available evidence with and ongoing evaluation of other promising agents and strategies for advanced GE cancers
  • ||||||||||  MODULE 3: Selection and Sequencing of Therapy for Relapsed/Refractory Gastric/GEJ Cancer; Novel Investigational Approaches (San Francisco Marriott Marquis, Golden Gate Ballroom, Salon A (B2 Level)) -  Dec 23, 2022 - Abstract #ASCOGI2023ASCO_GI_956;    
    CME Provider and Supporter(s): This event is organized and accredited by Research to Practice and supported through educational grants provided by Astellas, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Daiichi Sankyo Inc, and Lilly. Published findings with and optimal integration of ramucirumab into current clinical algorithms for metastatic gastric/GEJ cancer; role of this agent for patients experiencing disease progression on an immune checkpoint inhibitor Rationale for, available data with and ongoing investigation of novel combination approaches (eg, ramucirumab with TAS-102 or anti-PD-1 antibodies) Biologic rational for targeting claudin 18.2 in gastric/GEJ cancer; mechanism of action of and early efficacy and safety data with zolbetuximab for advanced gastric/GEJ adenocarcinoma with claudin 18.2 expression Emerging positive findings from the Phase III SPOTLIGHT study of first-line zolbetuximab in combination with chemotherapy for patients with claudin 18.2-positive metastatic gastric/GEJ cancer Mechanism of action of bemarituzumab; available efficacy and safety data with and ongoing Phase III evaluation of first-line bemarituzumab/chemotherapy for FGFR2b-positive metastatic gastric/GEJ cancer Other promising novel agents and strategies under investigation for HER2-negative gastric/GEJ cancer
  • ||||||||||  bemarituzumab (AMG 552) / Amgen
    Enrollment change, Trial primary completion date, Monotherapy:  A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201) (clinicaltrials.gov) -  Dec 20, 2022   
    P1b,  N=180, Recruiting, 
    Published findings with and optimal integration of ramucirumab into current clinical algorithms for metastatic gastric/GEJ cancer; role of this agent for patients experiencing disease progression on an immune checkpoint inhibitor Rationale for, available data with and ongoing investigation of novel combination approaches (eg, ramucirumab with TAS-102 or anti-PD-1 antibodies) Biologic rational for targeting claudin 18.2 in gastric/GEJ cancer; mechanism of action of and early efficacy and safety data with zolbetuximab for advanced gastric/GEJ adenocarcinoma with claudin 18.2 expression Emerging positive findings from the Phase III SPOTLIGHT study of first-line zolbetuximab in combination with chemotherapy for patients with claudin 18.2-positive metastatic gastric/GEJ cancer Mechanism of action of bemarituzumab; available efficacy and safety data with and ongoing Phase III evaluation of first-line bemarituzumab/chemotherapy for FGFR2b-positive metastatic gastric/GEJ cancer Other promising novel agents and strategies under investigation for HER2-negative gastric/GEJ cancer N=108 --> 180 | Trial primary completion date: Feb 2024 --> Jul 2024
  • ||||||||||  zolbetuximab (IMAB362) / Astellas, bemarituzumab (AMG 552) / Amgen
    Review, Journal, IO biomarker:  Oesogastric cancer - new therapeutic targets (Pubmed Central) -  Nov 15, 2022   
    FGFR2 is overexpressed in one third of patients, and its targeting with a specific monoclonal antibody bemarituzumab showed a significant improvement in survival...The combination of zolbetuximab and chemotherapy provides a survival benefit, correlated with the intensity of CLDN 18.2 expression...Finally, with the recent advent of immunotherapy, one of the future challenges will be to optimize it through combination strategies with targeted therapies. The combination of anti-angiogenic and immunotherapy seems promising in gastric cancer.
  • ||||||||||  bemarituzumab (AMG 552) / Amgen
    Journal:  Bemarituzumab enters the FIGHT. (Pubmed Central) -  Nov 4, 2022   
    Confirmatory phase 3 trials of bemarituzumab plus mFOLFOX6 powered to demonstrate statistical significance are being investigated in patients with previously untreated, FGFR2b-overexpressing, advanced gastric or gastro-oesophageal junction adenocarcinoma. No abstract available
  • ||||||||||  bemarituzumab (AMG 552) / Amgen
    Review, Journal:  Targeting FGFR2 Positive Gastroesophageal Cancer: Current and Clinical Developments. (Pubmed Central) -  Oct 15, 2022   
    A selective FGFR2b monoclonal antibody bemarituzumab is currently being investigated in the first phase III randomized trial for patients with first line advanced GC, which may change the treatment paradigm for FGFR2b positive GC...Precision medicine is part of the wider approach in gastrointestinal cancers; however, it can be challenging due to heterogeneity and here circulating tumour DNA (ctDNA) for patient selection may have future clinical utility. In our review, we outline the FGFR pathway and focus on the developments and challenges of targeting FGFR2 driven gastroesophageal cancers.