Erbitux (cetuximab) / Eli Lilly 
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  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Biomarker, Review, Journal, Tumor microenvironment, PD(L)-1 Biomarker, IO biomarker:  The Role of Cytokinome in the HNSCC Tumor Microenvironment: A Narrative Review and Our Experience. (Pubmed Central) -  Nov 27, 2022   
    In recent years, many predictive and prognostic biomarkers have been studied in the HNSCC TME, but none of them alone can select the best candidates for response to ICIs or targeted therapy (e.g., Cetuximab)...An immune response against HNSCC results in the production of some cytokines that induce a pro-inflammatory response and attract cells, such as neutrophils, macrophages, and T cell effectors, to enhance the innate and adaptive anti-tumor response. We revised the role of a group of cytokines as biomarkers for treatment response in HNSCC.
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Biomarker, Review, Journal:  Pharmacogenetics Role of Genetic Variants in Immune-Related Factors: A Systematic Review Focusing on mCRC. (Pubmed Central) -  Nov 27, 2022   
    The remaining published data are sparse and mainly hypothesis-generating but suggest potentially interesting topics for future pharmacogenetic studies, including innovative gene-drug interactions in a clinical context. Besides the tumor immune escape pathway, genetic markers belonging to cytokines/interleukins (IL-8 and its receptors) and angiogenic mediators (IGF1) seem to be the best investigated and hopefully most promising to be translated into clinical practice after validation.
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Journal:  A fluorescent photoimmunoconjugate for imaging of cholesteatoma. (Pubmed Central) -  Nov 21, 2022   
    This study investigates a novel application of the photosensitizer immune conjugate (PIC) cetuximab-benzoporphyrin derivative (Cet-BPD) for in vitro localization of human cholesteatoma tissue, coupled with an in vivo safety study for middle ear application of Cet-BPD in a murine model...Applied to the murine middle ear, Cet-BPD does not demonstrate any deleterious effect on murine hearing when assessed by any of auditory brainstem response (ABR) thresholds, distortion product otoacoustic emission thresholds, or ABR wave I amplitudes. These findings demonstrate the technical promise and encouraging safety profile for the use of PICs for intraoperative localization and treatment of cholesteatoma.
  • ||||||||||  ASP3082 / Astellas
    Enrollment change, Metastases:  A Study of ASP3082 in Adults With Previously Treated Solid Tumors (clinicaltrials.gov) -  Nov 21, 2022   
    P1,  N=240, Recruiting, 
    These findings demonstrate the technical promise and encouraging safety profile for the use of PICs for intraoperative localization and treatment of cholesteatoma. N=136 --> 240
  • ||||||||||  Journal:  KRAS inhibitors: Going non-covalent. (Pubmed Central) -  Nov 18, 2022   
    Informed by the structure of the KRAS inhibitor adagrasib, Hallin et al have now, through multiple rounds of structure-based drug design, identified and validated a potent, selective, and non-covalent KRAS inhibitor, MRTX1133. This study demonstrated that MRTX1133 inhibited both the inactive and active state of KRAS and showed potent anti-tumor activity in several pre-clinical models of pancreatic and colorectal cancer, especially when combined with cetuximab, a monoclonal antibody against the EGFR, or BYL-719, a potent PI3Kα inhibitor.
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Journal:  Platycodin D sensitizes KRAS-mutant colorectal cancer cells to cetuximab by inhibiting the PI3K/Akt signaling pathway. (Pubmed Central) -  Nov 18, 2022   
    Our results confirmed that platycodin-D increased the cytotoxic effects of cetuximab, including inhibition of growth, migration, and invasion, via downregulation of PI3K and Akt phosphorylation in HCT116 and LoVo cells both in vitro and in vivo. Given these data, platycodin-D may sensitize KRAS-mutant colorectal cancer cells to cetuximab via inhibition of the PI3K/Akt signaling pathway.
  • ||||||||||  Dupixent (dupilumab) / Sanofi, Regeneron
    Journal:  The Combination of Dupilumab with Other Monoclonal Antibodies. (Pubmed Central) -  Nov 16, 2022   
    Because the evidence is modest, the question remains open as to whether dupilumab can be safely combined with other monoclonal antibodies. Dupilumab does not exert immunosuppressive effects and does not impair the activity of cytochrome P450 isozymes.
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Journal:  Stereotactic body radiotherapy plus cetuximab for previously irradiated un-resectable head and neck cancer. (Pubmed Central) -  Nov 16, 2022   
    The extent of the loss of skin barrier function may be important for determining the severity of skin toxicity development. SBRT plus cetuximab provides a promising salvage strategy for those patients with previously irradiated but unresectable rHNSCC, especially those with a re-irradiation interval >12 months or GTV ≦ 50 ml.
  • ||||||||||  TheraCIM (nimotuzumab) / Daiichi Sankyo, Oncoscience, Biocon, Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Journal:  Efficacy and safety of a treatment in patients with locoregionally advanced nasopharyngeal carcinoma (LANC) involving carotid artery invasion. (Pubmed Central) -  Nov 15, 2022   
    In LANC patients whose carotid artery invasion was < 270°, induction chemotherapy (IC) followed by helical tomotherapy (HT) and concurrent chemoradiotherapy (CCRT) with EGFR (epidermal growth factor receptor) inhibitor had mild and tolerable side effects, better PFS and DMFS, with no massive hemorrhage. In patients whose primary tumor was pharyngeal recess with carotid artery invasion ≥ 270°, poorly controlled diabetes or re-radiotherapy led to a higher risk of massive hemorrhage after radiotherapy.
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Journal:  Cetuximab-Based vs Carboplatin-Based Chemoradiotherapy for Patients With Head and Neck Cancer. (Pubmed Central) -  Nov 15, 2022   
    In this cohort study of a US veteran population with HNSCC undergoing treatment with CRT, almost a third of patients were ineligible to receive treatment with cisplatin and received cetuximab-based or carboplatin-based radiosensitization. After propensity score matching, carboplatin-based systemic therapy was associated with 15% improvement in overall survival compared with cetuximab, suggesting that carboplatin may be the preferred radiosensitizer, particularly in oropharynx cancers.
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono, Gilotrif (afatinib) / Boehringer Ingelheim
    Circulating tumor DNA (ctDNA) kinetics predict progression-free and overall survival in EGFR TKI-treated patients with EGFR-mutant NSCLC (SWOG S1403) () -  Nov 15, 2022 - Abstract #SWOGFall2022SWOG_Fall_140;    
    Experimental design: Serial plasma ctDNA (baseline, 8 weeks, and at progression) was prospectively incorporated into the SWOG S1403 clinical trial of afatinib ± cetuximab in tyrosine kinase inhibitor-naïve, EGFR mutation tissue-positive non-small cell lung cancer. Plasma clearance of mutant EGFR ctDNA at 8 weeks was highly and significantly predictive of PFS and OS, outperforming RECIST response for predicting long-term benefit.
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Journal:  EGFR-induced suppression of HPV E6/E7 is mediated by microRNA-9-5p silencing of BRD4 protein in HPV-positive head and neck squamous cell carcinoma. (Pubmed Central) -  Nov 13, 2022   
    Inhibition of EGFR by cetuximab restored the expression of BRD4 leading to increased HPV E6 and E7 transcription...These results suggest a novel mechanism for EGFR inhibition of HPV E6/E7 oncoprotein expression through an epigenetic pathway, independent of MAPK, but mediated through microRNA-9-5p/BRD4 regulation. Therefore, targeting EGFR may not be the best course of therapy for certain cancer types including HPV-positive HNSCC, while targeting specific signalling pathways such as BRD4 could provide a better and potentially new treatment to improve HNSCC therapeutic outcome.
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Journal:  Resistance Mechanisms to Anti-EGFR Therapy in RAS/RAF Wildtype Colorectal Cancer Vary by Regimen and Line of Therapy. (Pubmed Central) -  Nov 10, 2022   
    These findings support a model of resistance whereby transcriptomic mechanisms of resistance predominate in the presence of active cytotoxic chemotherapy combined with EGFRi, with a greater predominance of acquired MAPK mutations after single-agent EGFRi. The proposed model has implications for prospective studies evaluating EGFRi rechallenge strategies guided by acquired MAPK mutations, and highlights the need to address transcriptional mechanisms of resistance.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Erbitux (cetuximab) / Eli Lilly, EMD Serono, Opdivo (nivolumab) / Ono Pharma, BMS
    Journal, PD(L)-1 Biomarker, IO biomarker:  Emerging tyrosine kinase inhibitors for head and neck cancer. (Pubmed Central) -  Nov 9, 2022   
    The design of clinical trials of TKIs has been hampered by a lack of understanding of biomarkers that can be used to define patient populations most likely to respond. Further preclinical and translational studies to define biomarkers of TKI response will be critically important.
  • ||||||||||  Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Journal, PARP Biomarker, IO biomarker:  Gene interaction perturbation network deciphers a high-resolution taxonomy in colorectal cancer. (Pubmed Central) -  Nov 9, 2022   
    Here, we introduce an individual-specific gene interaction perturbation network-based (GIN) approach and identify six GIN subtypes (GINS1-6) with distinguishing features: (i) GINS1 (proliferative, 24%~34%), elevated proliferative activity, high tumor purity, immune-desert, PIK3CA mutations, and immunotherapeutic resistance; (ii) GINS2 (stromal-rich, 14%~22%), abundant fibroblasts, immune-suppressed, stem-cell-like, SMAD4 mutations, unfavorable prognosis, high potential of recurrence and metastasis, immunotherapeutic resistance, and sensitive to fluorouracil-based chemotherapy; (iii) GINS3 (KRAS-inactivated, 13%~20%), high tumor purity, immune-desert, activation of EGFR and ephrin receptors, chromosomal instability (CIN), fewer KRAS mutations, SMOC1 methylation, immunotherapeutic resistance, and sensitive to cetuximab and bevacizumab; (iv) GINS4 (mixed, 10%~19%), moderate level of stromal and immune activities, transit-amplifying-like, and TMEM106A methylation; (v) GINS5 (immune-activated, 12%~24%), stronger immune activation, plentiful tumor mutation and neoantigen burden, microsatellite instability and high CpG island methylator phenotype, BRAF mutations, favorable prognosis, and sensitive to immunotherapy and PARP inhibitors; (vi) GINS6, (metabolic, 5%~8%), accumulated fatty acids, enterocyte-like, and BMP activity. Overall, the novel high-resolution taxonomy derived from an interactome perspective could facilitate more effective management of CRC patients.
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Journal, Tumor Mutational Burden, PD(L)-1 Biomarker, IO biomarker:  Amino acid metabolism-based molecular classification of colon adenocarcinomavia in silico analysis. (Pubmed Central) -  Nov 8, 2022   
    To provide perspectives on cell-specific metabolism for further investigation, we explored metabolic activity in different cell types including lymphocytes, mast cells, myeloid cells stromal cells, and epithelial cells via colorectal cancer single-cell data. Additionally, to assist in clinical decision-making and prognosis prediction, a 60-AAMRG-based classifier was generated and validated in an independent cohort.
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono, Gilotrif (afatinib) / Boehringer Ingelheim
    Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy, EGFR exon 20:  AFACET: Afatinib and Cetuximab in Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Positive Non-small-cell Lung Cancer (clinicaltrials.gov) -  Nov 8, 2022   
    P2,  N=37, Active, not recruiting, 
    Additionally, to assist in clinical decision-making and prognosis prediction, a 60-AAMRG-based classifier was generated and validated in an independent cohort. Recruiting --> Active, not recruiting | Trial completion date: Feb 2022 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022