patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD) 
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  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo
    HER3-DXd (Twitter) -  May 3, 2022   
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Tagrisso (osimertinib) / AstraZeneca
    Phase 1 study of patritumab deruxtecan (HER3-DXd; U3-1402) in combination with osimertinib in patients with advanced EGFR-mutated NSCLC. (Available On Demand; 147b) -  Apr 28, 2022 - Abstract #ASCO2022ASCO_5196;    
    P1
    If the RCD includes an osimertinib dose of 80 mg PO QD, ≈30 pts with advanced EGFRm NSCLC without prior treatment will be enrolled and treated at the RCD in a separate cohort; the primary objective is to assess safety and tolerability. A tumor sample after progression with osimertinib (or prior to entry) is required for pts enrolled in dose expansion for retrospective evaluation of HER3 and biomarker analyses.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo
    HER3 expression in metastatic colorectal cancer: Defining the clinicomolecular profile of an emerging target. (Available On Demand; 382) -  Apr 28, 2022 - Abstract #ASCO2022ASCO_1389;    
    For example, patritumab deruxtecan (U3-1402; HER3-DXd) is a HER3-directed antibody drug conjugate that has demonstrated clinically meaningful antitumor activity and acceptable safety profiles in metastatic breast cancer and EGFR-mutated non-small cell lung cancer... In this large cohort of mCRC, HER3 expression was observed in 92.8% of patients and across diverse clinical and molecular features, supporting HER3 as a promising targetable biomarker in a large subset of mCRC.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo
    A Phase II Study of HER3-DXD in Patients (pts) with Metastatic Breast Cancer (MBC) (Exhibition area) -  Mar 19, 2022 - Abstract #ESMOBC2022ESMO_BC_401;    
    P2
    Part B will enroll ∼60 pts (20 pts in up to 3 subgroups) as defined from the biomarker expression pattern and preliminary efficacy findings from Part A. Pts from the same biomarker subgroups in Parts A and B will be pooled for the final efficacy analysis. Enrollment to Part A was initiated in November 2020.
  • ||||||||||  Review, Journal:  Antibody-Drug Conjugates Targeting the Human Epidermal Growth Factor Receptor Family in Cancers. (Pubmed Central) -  Mar 18, 2022   
    In this review article, we summarize the three approved ADCs (T-DM1, DS-8201a and RC48), together with the investigational EGFR-directed ADCs (ABT-414, MRG003 and M1231), HER2-directed ADCs (SYD985, ARX-788, A166, MRG002, ALT-P7, GQ1001 and SBT6050) and HER3-directed ADC (U3-1402). Lastly, we discuss the major challenges associated with the development of ADCs, and highlight the possible future directions to tackle these challenges.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, patritumab (U3-1287) / Amgen, Daiichi Sankyo
    HER3 is an actionable target in advanced prostate cancer (Section 32) -  Mar 9, 2022 - Abstract #AACR2022AACR_4583;    
    HER3 is commonly expressed in advanced PC and has clinical relevance in this setting. Our data indicate that HER3 is a valid target for clinical trials for men suffering from high HER3 expressing advanced PC.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo
    Journal:  EGFR inhibition enhances the cellular uptake and antitumor-activity of the HER3 antibody drug conjugate HER3-DXd. (Pubmed Central) -  Feb 19, 2022   
    We further developed a preclinical strategy to enhance the efficacy of HER3-DXd through osimertinib pre-treatment, which increased membrane expression of HER3 and led to enhanced internalization and efficacy of HER3-DXd. The combination of osimertinib and HER3-DXd may be an effective treatment approach and should be evaluated in future clinical trials in EGFR-mutant NSCLC patients.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo
    Journal:  Antibody-Drug Conjugates: A New Addition to the Treatment Landscape of EGFR-Mutant Non-Small Cell Lung Cancer. (Pubmed Central) -  Feb 11, 2022   
    Haikala and colleagues have developed a unique strategy using patritumab deruxtecan, an antibody-drug conjugate targeting human epidermal growth factor receptor 3 (HER3) linked to exatecan derivatives, for treating EGFR-mutant NSCLC...In parallel, Jänne and colleagues reported the clinical activity of patrimumab deruxtecan in patients with EGFR-mutant NSCLC with prior EGFR TKI treatment. These two studies provide the grounds for hopeful anticipation for a novel strategy that concurrently targets compensatory feedback loops in addition to oncogenic signaling pathways.See related article by Haikala et al., p. 130.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo
    Journal:  Patritumab Deruxtecan: Paving the Way for EGFR-TKI-Resistant NSCLC. (Pubmed Central) -  Feb 8, 2022   
    HER3 is ubiquitously expressed in EGFR-mutant non-small cell lung cancer (NSCLC) irrespective of resistant mechanisms to EGFR tyrosine kinase inhibitors, thus garnering attention as a valuable therapeutic target. In this issue of Cancer Discovery, Jänne and colleagues highlight early clinical data supporting patritumab deruxtecan as a potentially appreciable agent for previously treated EGFR-mutant NSCLC.See related article by Jänne et al., p. 74.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo
    Journal:  HER3 is an Actionable Target in Advanced Prostate Cancer. (Pubmed Central) -  Jan 7, 2022   
    Targeting HER3, especially with the HER3 directed antibody-drug conjugate U3-1402, exhibited antitumor activity against HER3-expressing PC. Overall, this data indicates that HER3 is commonly overexpressed in lethal PC and can be activated by NRG1 secreted by myelomonocytic cells in the tumor microenvironment, supporting HER3-targeted therapeutic strategies for treating HER3-expressing advanced CRPC.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Metastases:  A Study to Evaluate U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer (clinicaltrials.gov) -  Nov 19, 2021   
    P2,  N=40, Terminated, 
    N=80 --> 40 | Trial completion date: May 2023 --> Nov 2021 | Recruiting --> Terminated | Trial primary completion date: Feb 2023 --> Nov 2021; Study was terminated early given the Interim Analysis for Part 1 (signal finding) did not meet pre-specified criteria and will not proceed to Part 2. Sponsor will proceed closing the study.