Libtayo (cemiplimab-rwlc) / Regeneron 
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  • ||||||||||  Libtayo (cemiplimab) / Regeneron
    Real world experience of immunotherapy in an elderly trial-ineligible cohort of patients with advanced cutaneous squamous cell carcinoma (Hall C) -  Oct 6, 2022 - Abstract #SITC2022SITC_1566;    
    The cemiplimab registrational study, which established immunotherapy as the standard of care for advanced CSCC, enrolled patients with a median age of 71 years (73% over 65 years, n=43)...With a median follow up of 7.9 months, median OS was 20.5 months (95%CI 11-NA) (Figure 1) and median DSS 25.6 months (95%CI 20.5-NA) (Figure 2). Conclusions Immunotherapy is effective and well tolerated among elderly trial-ineligible patients with advanced CSCC with no increase in toxicity and a comparable efficacy to what has been demonstrated in current clinical trials.
  • ||||||||||  Libtayo (cemiplimab) / Regeneron
    Prediction of HCC response to neoadjuvant immunotherapy using multiparametric magnetic resonance imaging: a preliminary study. (Hall C) -  Oct 6, 2022 - Abstract #SITC2022SITC_1007;    
    Methods In this prospective IRB-approved single-center study, we included 17 patients (M/F 14/3, mean age 65y) with resectable HCC who underwent mpMRI including T1 mapping, 3D MR elastography (MRE), diffusion-weighted imaging (DWI), and dynamic contrast-enhanced (DCE)-MRI with a hepatobiliary contrast agent (gadoxetic acid, Eovist/Primovist, Bayer), at pre-treatment and after completion of anti PD-1 immunotherapy (cemiplimab) as part of a trial...Conclusions Our results demonstrate the potential utility of native T1 and upslope measured with DCE-MRI for predicting HCC response to neoadjuvant immunotherapy. These findings require validation in an independent study.
  • ||||||||||  Libtayo (cemiplimab) / Regeneron, T-cell receptor therapy / Regeneron, 2seventy bio
    Comprehensive single cell sequencing analysis of paired tissue and blood samples from HCC patients treated with neoadjuvant anti-PD-1 therapy reveals treatment-induced clonal T cell dynamics (Hall C) -  Oct 6, 2022 - Abstract #SITC2022SITC_905;    
    P2
    In a single-arm, open label phase 2 study, 21 patients with resectable (stage Ib, II, and IIIb) hepatocellular carcinoma (HCC) were treated with anti-PD-1 antibody, cemiplimab, in the neoadjuvant setting...Methods Single cell RNA (scRNA) and T cell receptor (TCR) sequencing were performed on tumor, normal adjacent tissues (NAT), tumor draining lymph node (tdLN), and blood from 20/21 patients at the time of resection...Our study suggests that tumor-expanded T cells are frequently found in the periphery, and peripheral expansion might correlate with response to neoadjuvant anti-PD-1 therapy. Trial Registration NCT03916627
  • ||||||||||  ISA101 / ISA Pharma
    Trial completion date, Trial primary completion date:  OpcemISA: A Randomized Phase 2 Study of Cemiplimab  (clinicaltrials.gov) -  Sep 27, 2022   
    P2,  N=194, Recruiting, 
    Table: 318P Conclusions In pts with advanced NSCLC, 1L cemiplimab+chemo demonstrated clinically meaningful and statistically significant improvement in OS, PFS, ORR and DOR vs chemo alone, with a safety profile consistent with cemiplimab monotherapy and platinum-based chemo. Trial completion date: Nov 2022 --> Dec 2024 | Trial primary completion date: Jun 2022 --> Dec 2022
  • ||||||||||  ASP8374 / Astellas
    Enrollment closed, Enrollment change:  ASP8374 + Cemiplimab in Recurrent Glioma (clinicaltrials.gov) -  Sep 26, 2022   
    P1,  N=14, Active, not recruiting, 
    Trial completion date: Nov 2022 --> Dec 2024 | Trial primary completion date: Jun 2022 --> Dec 2022 Recruiting --> Active, not recruiting | N=24 --> 14
  • ||||||||||  Biomarker, Review, Journal, Tumor Mutational Burden, PD(L)-1 Biomarker, IO biomarker:  Dermatologic Disease-Directed Targeted Therapy (DT): The Application of Biomarker-Based Precision Medicine for the Personalized Treatment of Skin Conditions-Precision Dermatology. (Pubmed Central) -  Sep 21, 2022   
    Advanced/metastatic basal and cutaneous squamous cell cancers often have a high tumor mutational burden (which predicts immunotherapy response); immune checkpoint blockade with cemiplimab, a programmed cell death protein 1 (PD1) inhibitor, is now approved for these malignancies...In the realm of rare neoplasms, PEComas-which can originate in the skin, albeit uncommonly-have tuberous sclerosis complex 1 (TSC1)/tuberous sclerosis complex 2 (TSC2) gene alterations, which activate mammalian target of rapamycin (mTOR) signaling, and can be suppressed by nab-sirolimus, now approved for this condition. In summary, precision dermatologic techniques/strategies are an important emerging approach for evaluation and management of skin disorders and cutaneous neoplasms, and may serve as a paradigm for the application of precision medicine beyond dermatology.