patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD) 
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  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
    Trial completion date, Trial primary completion date:  PARAMETer: A Window of Opportunity Study of Patritumab Deruxtecan in Patients with Brain Metastases (clinicaltrials.gov) -  Nov 21, 2024   
    P1,  N=15, Not yet recruiting, 
    The abstract will be released to the public on January 21, 2025 at 10:00 PM UTC Trial completion date: Jan 2027 --> Apr 2027 | Trial primary completion date: Jan 2025 --> Apr 2026
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
    Biomarker, Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Metastases:  ICARUS-BREAST01: Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) -  Nov 7, 2024   
    P2,  N=99, Active, not recruiting, 
    Trial completion date: Jan 2027 --> Apr 2027 | Trial primary completion date: Jan 2025 --> Apr 2026 Recruiting --> Active, not recruiting | N=170 --> 99 | Trial completion date: Jun 2026 --> Apr 2028 | Trial primary completion date: Jan 2024 --> Apr 2025
  • ||||||||||  Review, Journal:  Novel antibody-drug conjugates based on DXd-ADC technology. (Pubmed Central) -  Aug 31, 2024   
    This review provides a comprehensive assessment of drugs developed with DXd-ADC technology, with a focus on mechanisms of action, pharmacokinetics studies, preclinical data, and clinical outcomes for DS-8201a, U3-1402, DS-1062a, DS-7300a, DS-6157a, and DS-6000a. By integrating existing data, we aim to provide valuable insights into the current therapeutic status and future prospects of these novel agents.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
    Review, Journal:  Long road towards effective HER3 targeting in breast cancer. (Pubmed Central) -  Aug 17, 2024   
    In this review, we discuss the HER3 role in the pathogenesis of breast cancer and its relevance across all subtypes. We also explore the new anti-HER3 treatment strategies, calling into question the significance of HER3 detection as crucial information in breast cancer treatment.
  • ||||||||||  Opportunities for ADC Development in 2L NSCLC Leveraging Predictive Biomarkers (Exhibit Hall) -  Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1567;    
    While T-DXd and HER3-DXd have been tested in HER2 and EGFR mutated cohorts, respectively, Dato-DXd use has not shown to be impacted by any specific biomarker. These results indicate the need to identify predictive biomarkers of response for improved patient population selection.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
    Journal:  Spotlight on Patritumab Deruxtecan (HER3-DXd) from HERTHENA Lung01. Is a Median PFS of 5.5 Months Enough in Light of FLAURA-2 and MARIPOSA? (Pubmed Central) -  Jul 16, 2024   
    This prioritization by the FDA is grounded in compelling results from the global Phase II HERTHENA-Lung01 trial, wherein HER3-DXd exhibited clinically meaningful efficacy, achieving a median progression-free survival (mPFS) of 5.5 months in patients with heavily treated EGFR-mutated NSCLC. A pivotal question remains: Is a mPFS of 5.5 months sufficient in the context of the evolving first-line landscape observed in the FLAURA-2 and MARIPOSA trials?
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
    Is knowledge of HER3 as a prospective therapeutic biomarker necessary for pathologists? (Volta) -  Jun 28, 2024 - Abstract #ECP2024ECP_668;    
    In HER2-overexpressing (HER2 3+) tumor tissues, we found a potential correlation between HER3 overexpression and HER2 overexpression. However, whether HER3 expression is associated with disease progression and poor prognosis requires further in-depth analysis.HER3-Dxd has ignited the flames of anti-HER3 therapy, and we need to study HER3 more deeply and extensively in the laboratory.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
    Enrollment open, Trial completion date, Trial primary completion date, Metastases:  U31402-A-U102: HER3-DXd in Metastatic or Unresectable Non-Small Cell Lung Cancer (clinicaltrials.gov) -  May 14, 2024   
    P1,  N=309, Recruiting, 
    Trial primary completion date: Apr 2024 --> Dec 2025 Active, not recruiting --> Recruiting | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Jan 2022 --> Mar 2026
  • ||||||||||  DM002 / Doma Pharma, Biocytogen
    Preclinical Efficacy of DM002, a bispecific HER3 (Section 2) -  Mar 5, 2024 - Abstract #AACR2024AACR_5573;    
    DM002-BLD1102 also showed strong anti-tumor activity in DM002-vcMMAE resistant PDX models, suggesting the superiority of this new DNA topoisomerase I inhibitor linker/payload over the classical vcMMAE linker/payload. In conclusion, the HER3
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD), R3Mab / Roche, seribantumab (MM-121) / Elevation Oncology
    Therapeutic potential of a HER3 antibody-drug conjugate for the treatment of HER3-expressing cancers (Section 21) -  Mar 5, 2024 - Abstract #AACR2024AACR_5289;    
    Results from in vitro and in vivo studies highlight the promising therapeutic potential of a seribantumab-based ADC for patients with HER3-expressing cancers. Additional results on the optimization and characterization of HER3-ADC1 will be presented.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
    Review, Journal:  Targeting HER3 to overcome EGFR TKI resistance in NSCLC. (Pubmed Central) -  Jan 23, 2024   
    Preliminary results indicate combining HER3-specific treatments with EGFR TKIs enhances antitumor effects, leading to an increased objective response rate (ORR) and prolonged overall survival (OS) in resistant cases. Embracing HER3-targeting therapies represents a transformative approach against EGFR TKI resistance and emphasizes the importance of further research to optimize patient stratification and understand resistance mechanisms.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
    A phase 2 study of HER3-DXd in patients (pts) with metastatic breast cancer (MBC). () -  Jan 22, 2024 - Abstract #YIR2024YIR_124;    
    P2
    HER3-DXd had an acceptable safety profile, and the data further confirm the clinical activity in MBC in heavy pre-tx MBC across the broad range of HER3 expression levels. Parts B and Z are ongoing and data from this report support the potential entry of HER3-DXd into the therapeutic paradigm in MBC
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD), lumretuzumab (RG7116) / Roche, seribantumab (MM-121) / Elevation Oncology
    Review, Journal:  The Therapeutic Significance of HER3 in Non-small Cell Lung Cancer (NSCLC): A Review Study. (Pubmed Central) -  Jan 17, 2024   
    Additionally, antibody-drug conjugates (ADCs) like HER3-DXd (patritumab deruxtecan) are new drug candidates that have demonstrated selective delivery of cytotoxic chemicals to NSCLC cells by exploiting HER3's widespread expression, minimizing cytotoxicity. This review aims to evaluate the efficacy of current HER3 therapeutics in development and their therapeutic potential in NSCLC, incorporating evidence from clinical trials.