patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD) 
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 0 Diseases   8 Trials   8 Trials   181 News 


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  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo
    The impact of HER3 dynamics on the efficacy of HER3-DXd, a novel HER3 directed antibody-drug conjugate (Section 19; Poster Board #19) -  Mar 14, 2023 - Abstract #AACR2023AACR_6070;    
    HER3 expression was dynamically changed by HER3-DXd dosing regimen and by RTKi treatment, resulting in a substantial impact on payload release. These findings support our strategy of clinical studies using HER3-DXd after drugs that increase HER3 expression including EGFR TKI and indicate that HER3 dynamics may play a key role in achieving optimal efficacy of HER3-DXd.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
    Enrollment closed, Metastases:  U31402-A-U102: HER3-DXd in Metastatic or Unresectable Non-Small Cell Lung Cancer (clinicaltrials.gov) -  Feb 16, 2023   
    P1,  N=271, Active, not recruiting, 
    This new platform opens a new era of quantitative pharmacokinetic analysis, facilitating drug discovery and development. Recruiting --> Active, not recruiting
  • ||||||||||  HER3-DXd (U3-1402) / Daiichi Sankyo, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, telisotuzumab vedotin (ABBV-399) / AbbVie
    Review, Journal:  Antibody-drug conjugates in lung cancer: dawn of a new era? (Pubmed Central) -  Jan 12, 2023   
    In this review, we discuss the structure and mechanism of action of ADCs, including insights from pre-clinical work; we summarize the ADCs' recent progress in lung cancer, describe toxicity profiles of ADCs, and explore strategies designed to enhance ADC potency and overcome resistance. In addition, we discuss novel ADC strategies of interest in lung cancer, including non-cytotoxic payloads, such as immunomodulatory and anti-apoptotic agents.
  • ||||||||||  HER3-DXd (U3-1402) / Daiichi Sankyo, Dato-DXd (DS-1062a) / Daiichi Sankyo, AstraZeneca
    Exploring Daiichi Sankyo’sExtensive ADC Clinical Programme,Including HER3-DXd & Dato-DXd () -  Jan 2, 2023 - Abstract #ADCLondon2023ADC_London_143;    
    In addition, we discuss novel ADC strategies of interest in lung cancer, including non-cytotoxic payloads, such as immunomodulatory and anti-apoptotic agents. • HER3-DXd is an antibody-drug conjugate targeting HER-3 in Phase III trials • Dato-DXd is a Phase III ADC targeting HER-2 • Exploring the clinical updates of- DSI’s antibody-drug conjugate development pipeline
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Rybrevant (amivantamab-vmjw) / Genmab, J&J, Tagrisso (osimertinib) / AstraZeneca
    Review, Journal, IO biomarker:  New Strategies and Novel Combinations in EGFR TKI-Resistant Non-small Cell Lung Cancer. (Pubmed Central) -  Oct 28, 2022   
    In this review, we outline our proposed approach to current clinical practice for patients with EGFR mutant, osimertinib-resistant NSCLC which includes the following potential strategies: - Continuation of osimertinib beyond progression following local ablative treatment of oligoprogressive disease, - Tissue rebiopsy of progressive site and possibly concurrent liquid biopsy to evaluate for mechanism of resistance utilizing comprehensive genomic profiling, -Discussion at a molecular tumor board for assessment for enrollment in clinical trials/expanded access program if available with innovative drugs or possible off-label use of available targeted agents, based on the results of molecular profiling, -If no mechanism of resistance identified, administration of platinum-based chemotherapy with antiangiogenic agents. The role of immunotherapy will also be addressed given the uncertain benefit.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo
    PK/PD data, Journal:  Population Pharmacokinetics of Patritumab Deruxtecan in Patients With Solid Tumors. (Pubmed Central) -  Sep 3, 2022   
    Effects of these covariates on the exposure metrics were generally mild and did not require dose adjustment for subpopulations in subsequent development. Further PK characterization for patritumab deruxtecan will evolve with emerging data.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo
    SOLTI-1805 TOT-HER3 trial: A window-of-opportunity trial of patritumab deruxtecan (HER3-DXd) in patients with treatment-naïve, early breast cancer (Poster Area, Hall 4) -  Jul 28, 2022 - Abstract #ESMO2022ESMO_1913;    
    P1
    The primary objective of the part A was to evaluate the mean change in the CelTIL score (Nuciforo P., Annals Oncol 2018) between pre- and post-treatment tumor samples. Secondary objectives in the overall trial population and in part B include: variation in CelTIL score between paired tumor samples; overall response rate at C1D21; correlation between CelTIL change and baseline expression of ERBB3 and HER3 IHC; ERBB3 and HER3 dynamics; CelTIL variation across PAM50 subtypes; safety; and additional pharmacokinetic, genomic and circulating biomarkers.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
    Enrollment open, Metastases:  U31402-A-U102: HER3-DXd in Metastatic or Unresectable Non-Small Cell Lung Cancer (clinicaltrials.gov) -  Jul 8, 2022   
    P1,  N=264, Recruiting, 
    Secondary objectives in the overall trial population and in part B include: variation in CelTIL score between paired tumor samples; overall response rate at C1D21; correlation between CelTIL change and baseline expression of ERBB3 and HER3 IHC; ERBB3 and HER3 dynamics; CelTIL variation across PAM50 subtypes; safety; and additional pharmacokinetic, genomic and circulating biomarkers. Active, not recruiting --> Recruiting