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  • ||||||||||  Bekemv (eculizumab biosimilar) / Amgen
    Journal:  Functional similarity of ABP 959 and eculizumab in simulated serum models of aHUS and NMOSD. (Pubmed Central) -  Nov 13, 2023   
    This work presents a full comparison of the effect of C5 inhibition across five complement functional assays. Using this approach to confirm functional similarity of ABP 959 with eculizumab RP contributes to the TOE for biosimilarity and provides support for extrapolation based on inhibition of C5 function to other rare disease indications approved for eculizumab RP.
  • ||||||||||  Tavneos (avacopan) / Kissei, Amgen, Otsuka, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
    Journal, Immunomodulating:  The plethora of immunomodulatory drugs: opportunities for immune-mediated kidney diseases. (Pubmed Central) -  Nov 13, 2023   
    This new understanding challenges the clinical investigator to translate new knowledge into novel therapies leading to better disease outcomes. This review highlights promising immunomodulatory therapies tested for immune-mediated kidney diseases as a primary indication, detail current clinical trials and discuss pathways that could be targeted in the future.
  • ||||||||||  efruxifermin (AKR-001) / Amgen
    Journal:  Efruxifermin in non-alcoholic steatohepatitis. (Pubmed Central) -  Nov 13, 2023   
    This review highlights promising immunomodulatory therapies tested for immune-mediated kidney diseases as a primary indication, detail current clinical trials and discuss pathways that could be targeted in the future. No abstract available
  • ||||||||||  Review, Journal:  A narrative review of potential drug treatments for nephritis in children with IgA vasculitis (HSP). (Pubmed Central) -  Nov 13, 2023   
    Pegfilgrastim may decrease the incidence of aGVHD by boosting MDSCs, which need further investigation. Novel drugs that may be considered for use in early nephritis include TRF-budesonide; B-cell inhibiting agents including belimumab, telitacicept, blisibimod, VIS649, and BION-1301; B-cell depleting agents such as rituximab, ofatumumab, and bortezomib; sparsentan; angiotensin converting enzyme inhibitors (ACE-Is); and complement pathway inhibitors including avacopan, iptacopan, and narsoplimab.
  • ||||||||||  Praluent (alirocumab) / Sanofi, Regeneron, Repatha (evolocumab) / Amgen, Astellas
    Journal, Adverse events, Real-world evidence, Real-world:  Psychiatric disorders associated with PCSK9 inhibitors: A real-world, pharmacovigilance study. (Pubmed Central) -  Nov 11, 2023   
    The results of this study facilitate the prioritization of psychiatric AE signals by healthcare professionals with the goal of mitigating the risk of PCSK9i-related psychiatric AEs. However, as an exploratory study, our findings need to be confirmed in large-scale prospective studies.
  • ||||||||||  Krazati (adagrasib) / Mirati, Lumakras (sotorasib) / Amgen, garsorasib (D-1553) / InventisBio
    Retrospective data, Review, Journal:  Efficacy and toxicity of drugs targeting KRAS mutation in non-small cell lung cancer: a meta-analysis. (Pubmed Central) -  Nov 11, 2023   
    The most common grade???3 AEs were Alaninetransaminase (ALT) or Aspartatetransaminase (AST) increased and diarrhea. Sotorasib, Adagrasib, and Garsorasib as the drugs of choice for patients with KRAS mutation NSCLC, have definite efficacy and acceptable safety, especially for patients with advanced or metastatic disease and within posterior line therapy.
  • ||||||||||  Ibrance (palbociclib) / Pfizer, Kadcyla (ado-trastuzumab emtansine) / Roche
    Radiation myelopathy after standard dose radiation: potential radiation sensitizing effects of systemic therapy (Exhibit Hall A/B) -  Nov 11, 2023 - Abstract #SNO2023SNO_1106;    
    One began trastuzumab emtansine nine days after finishing radiation and the other started palbociclib three months afterwards, which was switched to capecitabine at disease progression...Both were treated with high-dose corticosteroid, vitamin E, and pentoxifylline...These cases are similar to recently reported instances of radiation myelopathy after standard dose spinal radiation followed by chemotherapy or immunotherapy. Recognition of the potential radiation sensitizing effects of systemic therapy should lead clinicians to consider radiation myelopathy early if spinal cord symptoms develop and to consider the timing of initiation of potential sensitizing drugs when spinal radiation has been given.
  • ||||||||||  Stivarga (regorafenib) / Bayer
    Assessment of response to regorafenib in recurrent glioma patients using FET PET and MRI including ADC values (Exhibit Hall A/B) -  Nov 11, 2023 - Abstract #SNO2023SNO_962;    
    Multivariate survival analyses revealed that relative mean TBR changes were most potent in predicting response to regorafenib (P=0.038; HR, 0.246) and absolute mean TBR values for prognostication (P < 0.001; HR, 0.005). Conclusion In contrast to MRI metrics, FET PET parameters are clinically valuable for identifying responders to regorafenib early after treatment initiation and helpful for prognostication.
  • ||||||||||  Avastin (bevacizumab) / Roche, Rintega (rindopepimut) / Celldex, Stivarga (regorafenib) / Bayer
    Targeted agents in patients with recurrent glioblastoma (Exhibit Hall A/B) -  Nov 11, 2023 - Abstract #SNO2023SNO_698;    
    Even though some studies revealed a benefit either for OS and/or PFS, results have to be critically reviewed regarding initial distribution of prognostic factors, underlying molecular mechanisms, sample size and trial design. There is a need for more specific and personalized study designs using newly obtained tumor tissue and close monitoring of treatment responses to allow for potential modification of treatment if needed.
  • ||||||||||  Lumakras (sotorasib) / Amgen
    The efficacy of sotorasib in KRAS-mutated NSCLC patients with brain metastases: a retrospective cohort study (Exhibit Hall A/B) -  Nov 11, 2023 - Abstract #SNO2023SNO_600;    
    There is a need for more specific and personalized study designs using newly obtained tumor tissue and close monitoring of treatment responses to allow for potential modification of treatment if needed. The results of this study indicate that while sotorasib does have intracranial activity, a multimodal approach to BM therapy is still warranted, as are future studies with larger patient samples, controls, and extended follow up.
  • ||||||||||  Stivarga (regorafenib) / Bayer
    Association of hand-foot skin reactions with survival in recurrent glioblastoma patients treated with regorafenib (Exhibit Hall A/B) -  Nov 11, 2023 - Abstract #SNO2023SNO_408;    
    Cox proportional hazards regression analysis confirmed that HFSR were associated with longer OS (P=0.039; HR, 0.438), independent of age, Karnofsky performance status, and the number of previous treatment lines (all P >0.05). ConclusionOur data suggest that the occurrence of HFSR following regorafenib is associated with longer OS in recurrent glioblastoma patients.
  • ||||||||||  Stivarga (regorafenib) / Bayer
    Assessment of response to regorafenib in recurrent glioma patients using FET PET and MRI including ADC values (Exhibit Hall A/B) -  Nov 11, 2023 - Abstract #SNO2023SNO_345;    
    Multivariate survival analyses revealed that relative mean TBR changes were most potent in predicting response to regorafenib (P=0.038; HR, 0.246) and absolute mean TBR values for prognostication (P < 0.001; HR, 0.005). Conclusion In contrast to MRI metrics, FET PET parameters are clinically valuable for identifying responders to regorafenib early after treatment initiation and helpful for prognostication.
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    BIOMARKERS AND CLINICAL OUTCOMES AFTER CESSATION OF TEZEPELUMAB AFTER 2 YEARS OF TREATMENT (DESTINATION) (St James, 4th floor) -  Nov 11, 2023 - Abstract #BTSWM2023BTS_WM_346;    
    P3
    From week 110, ACQ-6 score increased, and BEC and FeNO levels gradually increased in parallel with pre-BD FEV1 reductions. All measures continued to worsen over the extended follow-up, but did not return to baseline 36 weeks post treatment cessation (figure 1) Conclusion Biomarker suppression and improved clinical outcomes in patients gradually waned after cessation of tezepelumab, although, on average, none returned to baseline during the extended follow-up.
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    TEZEPELUMAB REDUCED OCS USE IN OCS-DEPENDENT PATIENTS WITH SEVERE ASTHMA: PHASE 3B WAYFINDER STUDY INTERIM RESULTS (St James, 4th floor) -  Nov 11, 2023 - Abstract #BTSWM2023BTS_WM_344;    
    P2, P3, P3
    All measures continued to worsen over the extended follow-up, but did not return to baseline 36 weeks post treatment cessation (figure 1) Conclusion Biomarker suppression and improved clinical outcomes in patients gradually waned after cessation of tezepelumab, although, on average, none returned to baseline during the extended follow-up. Methods Patients (18
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    THE PROPORTION OF PATIENTS ACHIEVING LOW BIOMARKER LEVELS WITH TEZEPELUMAB TREATMENT IN THE PHASE 3 NAVIGATOR STUDY (Cambridge, 5th floor) -  Nov 11, 2023 - Abstract #BTSWM2023BTS_WM_308;    
    P3
    At week 52, a greater proportion of tezepelumab recipients achieved BEC <150 cells/mL and <300 cells/mL, and FeNO levels <25 ppb and <50 ppb versus placebo recipients (figure 1). Conclusion At week 52, most tezepelumab recipients in NAVIGATOR had maintained or reduced their biomarker levels to below those associated with an increased risk of asthmarelated morbidity.
  • ||||||||||  Dupixent (dupilumab) / Sanofi, Regeneron, Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    CHANGE IN FENO WITH DUPILUMAB AND TEZEPELUMAB IN SEVERE EOSINOPHILIC ASTHMA (Cambridge, 5th floor) -  Nov 11, 2023 - Abstract #BTSWM2023BTS_WM_304;    
    In both cohorts, the majority of patients had evidence of persistent T2 inflammation with a FeNO >25ppb. The clinical implications of this residual inflammation and the longer term impact of continued treatment with either dupilumab or tezepelumab on FeNO requires further assessment.
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    INITIAL RESPONSES TO TEZEPELUMAB IN A COMPLEX SEVERE ASTHMA POPULATION (Westminster, 4th floor) -  Nov 11, 2023 - Abstract #BTSWM2023BTS_WM_267;    
    Conclusions In a complex, real world, severe asthma population, 8 weeks of Tezepelumab affords patients clinically significant improvements in ACQ-6 scores, a mean FEV1 improvement of 150 ml and, continued suppression of type 2 inflammation biomarkers. Whether this impact is sustained and leads to a reduction in OCS and annualised rate of asthma exacerbations requires further longitudinal studies.