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  • ||||||||||  Risk of Clostridioides difficile infection in patients with inflammatory bowel disease (Poster exhibition) -  Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_2005;    
    For RHEUMA-Bio, the biologics included were infliximab, adalimumab, golimumab, certolizumab, ustekinumab, secukinumab, etanercept, abatacept, tocilizumab, rituximab, guselkumab and ixekizumab...Biologic therapy was not associated with a higher risk of CDI. In IBD patients on biologic therapy, the number of biologics received increased the risk of CDI.
  • ||||||||||  Traficet-EN (vercirnon) / Amgen, AZD7798 / AstraZeneca
    First-time-in-human visualisation of CCR9 expression in the gut by positron emission tomography. (Poster exhibition) -  Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1276;    
    P1
    Conclusion We have developed a CCR9-specific PET tracer which potentially enables repeatable quantification of CCR9 expression in the gut. Ongoing studies will assess the effects of AZD7798 on CCR9+ cell depletion/repletion in the gut, providing critical data to support the clinical development programme.
  • ||||||||||  Tavneos (avacopan) / Kissei, Amgen, Otsuka
    Journal:  Avacopan for ANCA-associated vasculitis with hypoxic pulmonary haemorrhage. (Pubmed Central) -  Jan 25, 2024   
    We report the use of avacopan as a component of the treatment for pulmonary haemorrhage with hypoxia in AAV. Despite the life-threatening presentations all patients recovered, but attribution of the positive outcomes to avacopan is limited by the concomitant therapies and retrospective observational design.
  • ||||||||||  Ibrance (palbociclib) / Pfizer
    Trial primary completion date:  EORTC 1745-ETF-BCG: Adjuvant Palbociclib in Elderly Patients With Breast Cancer (clinicaltrials.gov) -  Jan 24, 2024   
    P2,  N=366, Active, not recruiting, 
    Not yet recruiting --> Recruiting | Initiation date: Nov 2023 --> Feb 2024 Trial primary completion date: Sep 2027 --> Jun 2026
  • ||||||||||  Lumakras (sotorasib) / Amgen, BMS-986466 / BridgeBio, BMS
    Journal:  Discovery of 1H-pyrazolo[3,4-b]pyrazine derivatives as selective allosteric inhibitor of protein tyrosine phosphatase SHP2 for the treatment of KRAS-mutant non-small cell lung cancer. (Pubmed Central) -  Jan 23, 2024   
    In this study, we used the previously reported SHP2 allosteric inhibitor IACS-13909 as a lead drug for structural derivation and modification, and synthesized three SHP2 inhibitors...Furthermore, the combination therapy of compound 4b and KRAS inhibitor sotorasib would play a strong synergistic effect against NCI-H358 cells...Molecular docking study predicted that compound 4b bound to the allosteric site of SHP2 and formed H-bond interactions with key residues Thr108, Glu110, Arg111, and Phe113. In summary, this study aims to provide new ideas for the development of SHP2 allosteric inhibitors for the treatment of KRAS mutant non-small cell lung cancer.Communicated by Ramaswamy H. Sarma.
  • ||||||||||  Review, Journal:  Hyperammonemic encephalopathy after tyrosine kinase inhibitors: A literature review and a case example. (Pubmed Central) -  Jan 23, 2024   
    More preclinical evidence is required to unveil the biochemical mechanisms responsible involved in this process and clinical studies are necessary to shed light on the prevalence, risk factors, management and prevention of this adverse event. It is important to monitor neurological symptoms and to measure ammonia levels when manifestations are detected.
  • ||||||||||  Krazati (adagrasib) / BMS, Avastin (bevacizumab) / Roche, Lumakras (sotorasib) / Amgen
    Review, Journal:  KRASG12C mutant lung adenocarcinoma: unique biology, novel therapies and new challenges. (Pubmed Central) -  Jan 23, 2024   
    Similar to other target therapies, clinical administration of KRASG12C inhibitors (sotorasib and adagrasib) resulted in acquired resistance due to various genetic changes not only in KRAS but in other oncogenes as well. Recent clinical studies are aiming to increase the efficacy of G12C inhibitors by novel combination strategies.
  • ||||||||||  Review, Journal:  Exploring the Spectrum of VEGF Inhibitors' Toxicities from Systemic to Intra-Vitreal Usage in Medical Practice. (Pubmed Central) -  Jan 23, 2024   
    The presentation and mechanisms of adverse effects resulting from VEGFi depend primarily on this distinction and the route of drug administration (systemic or intra-vitreal). This review provides a thorough examination of the causes, recognition, management, and preventive strategies for VEGFi toxicities with the goal of offering support to oncologists in both clinical practice and the design of clinical trials.
  • ||||||||||  tarlatamab (AMG 757) / Amgen
    Journal:  Second-Line Treatment Options for Small-Cell Lung Cancer: A Light at the End of the Tunnel. (Pubmed Central) -  Jan 23, 2024   
    Tarlatamab is a novel promising therapeutic antibody currently under investigation for its potential use in previously treated SCLC patients. This mini-review will explore the current state of second-line treatment options for SCLC, their clinical efficacy, and future directions.
  • ||||||||||  Enrollment change, Trial withdrawal:  SMMART Adaptive Clinical Treatment (ACT) Trial (clinicaltrials.gov) -  Jan 23, 2024   
    P1,  N=0, Withdrawn, 
    This mini-review will explore the current state of second-line treatment options for SCLC, their clinical efficacy, and future directions. N=25 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio
    Enrollment closed:  Effects of GRA in Patients With Type 1 (clinicaltrials.gov) -  Jan 23, 2024   
    P2,  N=30, Active, not recruiting, 
    N=25 --> 0 | Not yet recruiting --> Withdrawn Recruiting --> Active, not recruiting
  • ||||||||||  Aimovig (erenumab-aooe) / Amgen, Novartis
    Trial completion:  CHERUB01: Efficacy of Erenumab in Chronic Cluster Headache (clinicaltrials.gov) -  Jan 23, 2024   
    P2,  N=101, Completed, 
    Recruiting --> Active, not recruiting Active, not recruiting --> Completed
  • ||||||||||  Ibrance (palbociclib) / Pfizer
    Trial completion date, Trial primary completion date, Metastases:  PalboSarc: Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression. (clinicaltrials.gov) -  Jan 23, 2024   
    P2,  N=40, Recruiting, 
    Active, not recruiting --> Completed Trial completion date: Dec 2023 --> Sep 2024 | Trial primary completion date: Dec 2023 --> Sep 2024
  • ||||||||||  Ibrance (palbociclib) / Pfizer, Verzenio (abemaciclib) / Eli Lilly
    CDK4/6 inhibition is a potential vulnerability in NF1-depleted ER+ breast cancer () -  Jan 22, 2024 - Abstract #YIR2024YIR_137;    
    These data support a model whereby ER and RAS signaling converge upon CDK4/6, and CDK4/6 activation is a key survival mechanism when ER signaling is attenuated by treatment in NF1-depleted ER+ breast cancer cells. This apparent addiction for CDK4/6 activity makes NF1-depleted ER+ breast tumors vulnerable to CDK4/6 inhibition, thus creating a potential therapeutic opportunity to match CDK4/6 inhibition with patients who can benefit the most.
  • ||||||||||  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
  • ||||||||||  Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, Organon, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
    Retrospective data, Journal, Real-world evidence, Real-world:  Characteristics associated with response to subcutaneously administered anti-CGRP monoclonal antibody medications in a (Pubmed Central) -  Jan 22, 2024   
    Randomized clinical trials in individuals with more advanced CKD would be well posed to expand treatment options for this debilitating condition. In this real-world setting, anti-CGRP preventives reduced MDM persistently and had similar and large effect sizes on MDM reduction; however, clinical and genetic factors influenced response.
  • ||||||||||  Tepezza (teprotumumab) / Roche, Amgen
    Journal:  Aktuelle Therapieans (Pubmed Central) -  Jan 22, 2024   
    The management of these cases provides evidence of this new chemo-free regimen as an efficient approach for relapsed or refractory(R/R)Ph+ ALL. Teprotumumab (an inhibitory IGF1R antibody) has already been approved in the USA and the therapeutic effects are enormous, especially with regard to the reduction of exophthalmos...No abstract available
  • ||||||||||  Ibrance (palbociclib) / Pfizer
    Trial completion date, Trial primary completion date:  A Study of the Use of Text Message Reminders to Take Palbociclib (clinicaltrials.gov) -  Jan 22, 2024   
    P=N/A,  N=45, Active, not recruiting, 
    Teprotumumab (an inhibitory IGF1R antibody) has already been approved in the USA and the therapeutic effects are enormous, especially with regard to the reduction of exophthalmos...No abstract available Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024