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  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Kisqali (ribociclib) / Novartis
    Disseminated Invasive Lobular Carcinoma Metastasis of the Gastrointestinal Tract: An Oncologic Anomaly (Exhibit Hall) -  Jul 29, 2023 - Abstract #ACG2023ACG_2162;    
    An adjuvant therapy of Letrozole + Ribociclib was immediately initiated, and patient was discharged to follow up with oncology...Due to presence of skeletal metastasis, Denosumab was added for suppression of skeletal metastasis and secondary fracture prevention...Figure: Endoscopy and Colonoscopy evaluation of lesions: Endoscopy demonstrated Schatzki ring at the gastroesophageal junction (a), scattered inflammation and erythema in stomach (b), and severe intrinsic stenosis of pylorus (c). Colonoscopy demonstrating intrinsic stenosis of proximal rectum (d), and nodular erythematous mucosa of the transverse colon (e) and cecum (f).
  • ||||||||||  Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Aimovig (erenumab-aooe) / Amgen, Novartis
    What (Exhibit Hall) -  Jul 29, 2023 - Abstract #ACG2023ACG_1836;    
    These two cases of CGRP antagonist induced gastroparesis highlight important side effects to consider when deciding on a treatment plan for patients with migraines as well as a differential diagnosis to include for patients with gastroparesis. Figure: Figure 1 - Food residue noted on EGD Figure 2A - Nuclear medicine GES results with anterior and posterior views showing moderate retention of food in the stomach after 4 hours indicative of grade 2 gastroparesis Figure 2B - Graphic representation of GES results showing 50% gastric emptying time of 148 minutes and 21% retention at 4 hours
  • ||||||||||  Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
    Risankizumab for the Treatment of Moderate to Severe Crohn (Exhibit Hall) -  Jul 29, 2023 - Abstract #ACG2023ACG_1214;    
    The following doses of Risankizumab were studied: 200mg, 600mg, 1200mg IV and 180 mg SC. Clinical remission % (defined by CDAI score < 150) was less with 200 mg (15/41 - 37%) in phase 2 trial and was similar for 600mg and 1200mg dosing in the two phase 3 trials (42% vs 40%; 45% vs 42%).
  • ||||||||||  Taltz (ixekizumab) / Eli Lilly, Japan Tobacco, Enbrel (etanercept) / Pfizer, Amgen
    Recurrent Candida Esophagitis in a Patient With Psoriatic Arthritis Transitioning Immunologic Agents (Exhibit Hall) -  Jul 29, 2023 - Abstract #ACG2023ACG_977;    
    She was also recently transitioned from the IL-17a antagonist Ixekizumab to the TNFa inhibitor Etanercept for her poorly controlled psoriatic arthritis prior to admission, completing a total of 3 Etanercept doses...She was started on oral Fluconazole and discharged with resolution of her dysphagia...Middle (B): Middle Third of the Esophagus. Bottom (C): Lower Third of the Esophagus.
  • ||||||||||  Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, Enbrel (etanercept) / Pfizer, Amgen, Humira (adalimumab) / AbbVie
    Pyoderma Gangrenosum Masquerading as a Post Pancreatitis Fluid Collection (Exhibit Hall) -  Jul 29, 2023 - Abstract #ACG2023ACG_628;    
    Glucocorticosteroids are usually effective, but some patients may require immunosuppressants such as cyclosporine and dapsone. In refractory cases, biologics such as infliximab, adalimumab, and etanercept may be used.
  • ||||||||||  omecamtiv mecarbil (AMG 423) / Amgen, Servier
    Preclinical, Journal:  Phosphorylation Mimetic of Myosin Regulatory Light Chain Mitigates Cardiomyopathy-Induced Myofilament Impairment in Mouse Models of RCM and DCM. (Pubmed Central) -  Jul 29, 2023   
    The effects of the phosphomimetic S15D-RLC were compared with those observed for Omecamtiv Mecarbil (OM), a myosin activator shown to bind to the catalytic site of cardiac myosin and increase myocardial contractility...Additionally, treatment with OM resulted in significantly higher maximal pCa 4 force per cross-section of muscle fibers in both cardiomyopathy models. Our results suggest that both treatments with S15D-RLC and OM may improve the function of myosin motors and cardiac muscle contraction in RCM-ELC and DCM-RLC mice.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Review, Journal:  Harnessing the Immune System: Current and Emerging Immunotherapy Strategies for Pediatric Acute Lymphoblastic Leukemia. (Pubmed Central) -  Jul 29, 2023   
    The incorporation of these novel immunotherapies into ALL treatment, either as monotherapy or in combination with cytotoxic chemotherapy, has demonstrated promising potential to augment outcomes while decreasing toxicity. However, we also highlight the many challenges we still face and the research critically needed to achieve our goals for cure in children.
  • ||||||||||  Review, Journal:  MDM2 Inhibition in the Treatment of Glioblastoma: From Concept to Clinical Investigation. (Pubmed Central) -  Jul 29, 2023   
    While some MDM2 inhibitors have progressed to early phase clinical trials in GBM, their efficacy, alone and in combination, is yet to be confirmed. In this article, we present an overview of MDM2 inhibitors currently under preclinical and clinical investigation, with a specific focus on the drugs being assessed in ongoing clinical trials for GBM patients.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal, Surgery:  Sixty-Month Follow Up of Clinical MRONJ Cases Treated with CGF and Piezosurgery. (Pubmed Central) -  Jul 29, 2023   
    A comprehensive preoperative evaluation and collaboration among dental, endocrinology, and oncology specialists are crucial for personalized and multidisciplinary management. Ongoing research efforts are necessary to explore new therapeutic modalities and improve our understanding of MRONJ management, providing better support to patients dealing with this complex condition.
  • ||||||||||  olpasiran (AMG 890) / Amgen, pelacarsen (AKCEA-APO(a)-LRx) / Ionis, Novartis
    Review, Journal:  LP(a): Structure, Genetics, Associated Cardiovascular Risk, and Emerging Therapeutics. (Pubmed Central) -  Jul 28, 2023   
    Expected final online publication date for the Annual Review of Pharmacology and Toxicology, Volume 64 is January 2024. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.
  • ||||||||||  Repatha (evolocumab) / Amgen, Astellas
    Trial completion date, Trial primary completion date:  Lipid Management in Renal Transplant Recipients Using Evolocumab. (clinicaltrials.gov) -  Jul 28, 2023   
    P4,  N=120, Recruiting, 
    Trial completion date: Oct 2025 --> Mar 2026 | Trial primary completion date: Oct 2024 --> Mar 2025 Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Mar 2023 --> Mar 2024
  • ||||||||||  Vectibix (panitumumab) / Amgen
    Trial completion date, Trial primary completion date:  Women's MoonShot: Neoadjuvant Treatment With PaCT for Patients With Locally Advanced TNBC (clinicaltrials.gov) -  Jul 28, 2023   
    P2,  N=37, Recruiting, 
    Trial completion date: Aug 2023 --> Aug 2024 | Trial primary completion date: Aug 2023 --> Aug 2024 Trial completion date: Aug 2023 --> Aug 2025 | Trial primary completion date: Aug 2023 --> Aug 2025
  • ||||||||||  Neupogen (filgrastim) / Kyowa Kirin, Amgen
    Enrollment change:  Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors (clinicaltrials.gov) -  Jul 27, 2023   
    P3,  N=60000, Recruiting, 
    We describe herein our preliminary observation of one HR+HER2- advanced metastatic breast cancer patient diagnosed with vitiligo-like lesions after 10 N=40000 --> 60000
  • ||||||||||  Aimovig (erenumab-aooe) / Amgen, Novartis
    Enrollment closed:  CHERUB01: Efficacy of Erenumab in Chronic Cluster Headache (clinicaltrials.gov) -  Jul 27, 2023   
    P2,  N=101, Active, not recruiting, 
    Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting
  • ||||||||||  Vectibix (panitumumab) / Amgen
    Enrollment closed, Trial completion date, Trial primary completion date:  FOLFOXIRI Plus Panitumumab in Metastatic RAS Wild-type, Left-sided Colorectal Cancer (clinicaltrials.gov) -  Jul 27, 2023   
    P2,  N=27, Active, not recruiting, 
    Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Jan 2025 | Trial primary completion date: Mar 2023 --> Dec 2024
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Trial completion, Trial completion date, Trial primary completion date:  Study of TVEC in Patients With Cutaneous Squamous Cell Cancer (clinicaltrials.gov) -  Jul 27, 2023   
    P2,  N=11, Completed, 
    Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial completion date: Sep 2026 --> Jul 2023 | Trial primary completion date: Mar 2026 --> Jul 2023
  • ||||||||||  Enbrel (etanercept) / Pfizer, Amgen, Humira (adalimumab) / Eisai, AbbVie
    Journal:  Apical fibrobullous lung disease in spondyloarthritis patients with biological DMARD indication. (Pubmed Central) -  Jul 27, 2023   
    Active, not recruiting --> Completed As the radiological findings of AFLD can be confused with those of TB, special attention should be paid to differentiating between TB and the disease in males and in patients who have had long disease duration.
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    Review, Journal:  Efficacy and Potential Positioning of Tezepelumab in the Treatment of Severe Asthma. (Pubmed Central) -  Jul 27, 2023   
    Six clinical trials that included 2187 patients with uncontrolled asthma, with 2 or more exacerbations in the previous year, on medium/high-dose inhaled corticosteroids and at least 1 other controller, have demonstrated - irrespective of T2 endotype (and possibly also non-T2 endotype) - the efficacy and safety of tezepelumab, as it significantly reduces exacerbations (61.7%-66%) and bronchial hyperresponsiveness, and improves lung function, disease control, and quality of life. Tezepelumab could be indicated for the treatment of patients with, independently of the T2 phenotype (eosinophilic and non-eosinophilic), and may even be the only biologic available for treatment of non-T2 SUCA.
  • ||||||||||  Are bone targeted agents (BTAs) still useful in times of immunotherapy? The SAKK 80/19 BTA study () -  Jul 27, 2023 - Abstract #ESMO2023ESMO_3603;    
    Methods Pts with BM treated with IO within the Alpine Tumor Immunology Registry who received an additional BTA (denosumab, zoledronic acid) were compared with pts who have not received a BTA...Results In total, 197 pts with BM and treated with IO such as nivolumab (48%), pembrolizumab (40%), atezolizumab (12%), ipilimumab (9%) and other IO (5%) were included...Based on these retrospective results the indication of BTAs in cancer pts under treatment with IO must be challenged. Further prospective evaluation in a larger patient cohort is on the way.
  • ||||||||||  Systemic therapy for KIT/PDGFRA wild-type GIST () -  Jul 27, 2023 - Abstract #ESMO2023ESMO_3420;    
    Conclusions This retrospective series of KPWT GIST is one of the largest with this rare disease. Although there was no response to first line TKI imatinib, some long responders are reported with anti-angiogenic TKI and warrant additional investigation through prospective trials to validate those results.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Extending the interval of denosumab treatment for unresectable giant cell tumor of bone () -  Jul 27, 2023 - Abstract #ESMO2023ESMO_3411;    
    Conclusions 12-weekly de-escalated treatment of denosumab can sustain symptomatic relief, tumor reduction, and new bone formation achieved with standard treatment, resulting in effective maintenance treatment in patients with unresectable GCTB. 24-weekly treatment can also be selected, with careful attention to local recurrence.