Tepezza (teprotumumab-trbw) / Roche, Amgen 
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 18 Diseases   3 Trials   3 Trials   723 News 


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  • ||||||||||  teprotumumab (RG1507) / Horizon Therapeutics, Genmab
    Review, Journal:  Thyroid Eye Disease: How A Novel Therapy May Change The Treatment Paradigm. (Pubmed Central) -  Dec 10, 2019   
    Recent advances in the understanding of the molecular basis of TED have facilitated the development of targeted molecular therapies such as teprotumumab, an insulin-like growth factor-1 receptor inhibiting monoclonal antibody...The advent of effective medical therapy can lead to a paradigm shift in the clinical management of TED. This review will provide an overview of TED, its epidemiology, insight into the molecular biology of the disease, clinical characteristics and diagnosis, and current and emerging treatment modalities.
  • ||||||||||  teprotumumab (RG1507) / Horizon, Genmab
    Journal:  IGF-I receptor and thyroid-associated ophthalmopathy. (Pubmed Central) -  Oct 30, 2019   
    A recently completed therapeutic trial of teprotumumab, a human IGF-IR inhibiting antibody, in patients with moderate to severe, active TAO, indicates the potential effectiveness and safety of the drug. It is possible that other autoimmune diseases might benefit also benefit from this treatment strategy.
  • ||||||||||  teprotumumab (RG1507) / Horizon, Genmab
    Teprotumumab, a Novel Biologic for Active Thyroid Eye Disease (B302-B303) -  Oct 7, 2019 - Abstract #ACRARHP2019ACR_2817;    
    P2, P3
    In the largest placebo-controlled evaluation of active TED thus far conducted, teprotumumab reduced inflammation, proptosis, and diplopia resulting in clinical and quality of life improvements as compared with placebo over 24 weeks. Teprotumumab is a promising infused biologic option for TED, with implications for rheumatologists involved in managing patients with TED.
  • ||||||||||  teprotumumab (RG1507) / Horizon, Genmab, Nexavar (sorafenib) / Bayer, Amgen
    Discovery of highly potent and selective covalent inhibitors of FGFR4 (Board 72: Level 2 - Hall D) -  Sep 18, 2019 - Abstract #AACRNCIEORTC2019AACR_NCI_EORTC_505;    
    Sorafenib is currently the standard of care for advanced disease, provides a response rate of ~2% and median survival <11 months...BGS2219 was tested in a combo therapy regimen with R1507 (anti-IGFR1 mab) in RMS (rhabdomyosarcoma) xenograft model in mice and showed that BG2219 plus R1507 significantly reduce the tumor volume in comparison with R1507 alone...Tumor regression was achieved at high dose treatment. BGS22 treatment in vivo in HCC tumor bearing mice caused alteration of CYP7A1 and FGF19 expression, which were utilized as biomarkers for FGFR4 inhibition.
  • ||||||||||  Herceptin (trastuzumab) / Roche, Ultomiris IV (ravulizumab IV) / Alexion Pharma
    Journal:  Antibodies to watch in 2019. (Pubmed Central) -  Aug 1, 2019   
    In addition, our data show that 3 product candidates (leronlimab, brolucizumab, polatuzumab vedotin) may enter regulatory review by the end of 2018, and at least 12 (eptinezumab, teprotumumab, crizanlizumab, satralizumab, tanezumab, isatuximab, spartalizumab, MOR208, oportuzumab monatox, TSR-042, enfortumab vedotin, ublituximab) may enter regulatory review in 2019...Of these, 7 (tremelimumab, spartalizumab, BCD-100, omburtamab, mirvetuximab soravtansine, trastuzumab duocarmazine, and depatuxizumab mafodotin) are being evaluated in clinical studies with primary completion dates in late 2018 and in 2019, and are thus 'antibodies to watch'. We look forward to documenting progress made with these and other 'antibodies to watch' in the next installment of this article series.
  • ||||||||||  teprotumumab (RG1507) / Horizon, Genmab
    Journal:  The insulin-like growth factor-I receptor and its role in thyroid-associated ophthalmopathy. (Pubmed Central) -  Jul 6, 2019   
    We look forward to documenting progress made with these and other 'antibodies to watch' in the next installment of this article series. Should the current study yield similarly encouraging results, it is possible that teprotumumab will emerge as a paradigm-shifting medical therapy for TAO.
  • ||||||||||  Review, Journal:  Interruption of autoimmunity for thyroid eye disease: B-cell and T-cell strategy. (Pubmed Central) -  Jul 6, 2019   
    Infliximab might be useful in severe TED with optic nerve compression resistant to steroid and decompression. Indeed, the actual incidence of adverse effects is not well assessed yet, therefore the use should be limited at those cases that really need an alternative therapy to steroid, handled by an expert multidisciplinary team.
  • ||||||||||  teprotumumab (RG1507) / Horizon, Genmab
    Journal:  Insulin-like growth factor-I receptor and thyroid-associated ophthalmopathy. (Pubmed Central) -  May 16, 2019   
    Results of that trial in active, moderate to severe disease revealed dramatic and rapid reductions in disease activity and severity. Targeting IGF-IR with specific biologic agents may represent a paradigm shift in the therapy of TAO.
  • ||||||||||  teprotumumab (RG1507) / Horizon, Genmab
    Journal:  Update Graves' disease 2019 (Pubmed Central) -  May 5, 2019   
    Targeting IGF-IR with specific biologic agents may represent a paradigm shift in the therapy of TAO.  TRAb measurement can also be used for outcome prediction.
  • ||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma, Rituxan (rituximab) / Roche, Biogen
    Review, Journal:  Current and Emerging Treatment Strategies for Graves' Orbitopathy. (Pubmed Central) -  Apr 5, 2019   
    Use of new biologic agents, mainly teprotumumab and tocilizumab, have demonstrated impressive reductions in disease activity and severity...Finally, there are several novel immunotherapies being investigated for Graves' disease, which may have treatment implications for Graves' orbitopathy as well. Overall, there are many encouraging advances in the therapy of Graves' orbitopathy that are making the future more promising for patients suffering from this disease.
  • ||||||||||  Tepezza (teprotumumab) / Roche, Amgen
    Enrollment change, Trial primary completion date:  A Study of R1507 in Participants With Recurrent or Refractory Sarcoma (clinicaltrials.gov) -  Apr 4, 2017   
    P2,  N=317, Completed, 
    Active, not recruiting --> Completed N=228 --> 317 | Trial primary completion date: Jun 2010 --> Feb 2014
  • ||||||||||  Tepezza (teprotumumab-trbw) / Roche, Amgen
    Trial initiation date:  Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease (clinicaltrials.gov) -  Nov 25, 2016   
    P2,  N=84, Active, not recruiting, 
    N=228 --> 317 | Trial primary completion date: Jun 2010 --> Feb 2014 Initiation date: Apr 2013 --> Jul 2013
  • ||||||||||  Tepezza (teprotumumab-trbw) / Roche, Amgen
    Enrollment closed, Trial primary completion date:  Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease (clinicaltrials.gov) -  Sep 22, 2015   
    P2,  N=84, Active, not recruiting, 
    Trial primary completion date: Oct 2015 --> Aug 2016 Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2015 --> Mar 2016
  • ||||||||||  Tepezza (teprotumumab) / Roche, Amgen
    Enrollment open, Trial initiation date, Trial primary completion date:  A Phase 1, Open-Label Study of Teprotumumab in Patients With Diabetic Macular Edema (DME) (clinicaltrials.gov) -  Nov 4, 2014   
    P1,  N=10, Recruiting, 
    Trial primary completion date: Sep 2011 --> Jun 2010 Not yet recruiting --> Recruiting | Initiation date: Apr 2014 --> Oct 2014 | Trial primary completion date: Jun 2015 --> Oct 2015
  • ||||||||||  Tepezza (teprotumumab) / Roche, Amgen
    Trial primary completion date:  A Study of R1507 in Participants With Recurrent or Refractory Sarcoma (clinicaltrials.gov) -  Oct 17, 2014   
    P2,  N=228, Completed, 
    Not yet recruiting --> Recruiting | Initiation date: Apr 2014 --> Oct 2014 | Trial primary completion date: Jun 2015 --> Oct 2015 Trial primary completion date: Feb 2014 --> Jun 2010