Libtayo (cemiplimab-rwlc) / Regeneron 
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 1 Disease   67 Trials   67 Trials   1555 News 


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  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Enrollment closed, Trial completion date, Trial primary completion date:  PRIME-CUT: REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer (clinicaltrials.gov) -  Sep 25, 2023   
    P2,  N=20, Active, not recruiting, 
    Further investigations are needed to get additional information. Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Apr 2028 | Trial primary completion date: Dec 2022 --> Mar 2024
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Journal:  European consensus-based interdisciplinary guideline for invasive cutaneous squamous cell carcinoma: Part 2. Treatment-Update 2023. (Pubmed Central) -  Sep 14, 2023   
    For patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiotherapy, anti-PD-1 agents are the first-line systemic treatment, with cemiplimab being the first approved systemic agent for advanced cSCC by the Food and Drugs Administration/European Medicines Agency. Second-line systemic treatments for advanced cSCC, include epidermal growth factor receptor inhibitors (cetuximab) combined with chemotherapy or radiotherapy...Patients should be engaged in informed, shared decision-making on management and be provided with the
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Journal:  Cemiplimab-Induced Alopecia Areata. (Pubmed Central) -  Sep 13, 2023   
    Second-line systemic treatments for advanced cSCC, include epidermal growth factor receptor inhibitors (cetuximab) combined with chemotherapy or radiotherapy...Patients should be engaged in informed, shared decision-making on management and be provided with the No abstract available
  • ||||||||||  linvoseltamab (REGN5458) / Regeneron
    Trial in Progress: Linvoseltamab, a BCMAxCD3 bispecific antibody, in a Phase 1b multi-cohort study of combination regimens for patients with relapsed/refractory multiple myeloma (Trianti Upper Foyer; In Person) -  Sep 10, 2023 - Abstract #IMW2023IMW_319;    
    P1/2, P1b
    LINKER-MM2 (NCT05137054) is a global, Phase 1b, open-label, multi-cohort study designed to assess the safety, tolerability, and efficacy of linvoseltamab in combination with nine different agents (daratumumab, carfilzomib, lenalidomide, bortezomib, pomalidomide, isatuximab, fianlimab, cemiplimab, or nirogacestat) in separate cohorts of participants with RRMM. Analyses from the LINKER-MM2 study will provide important information on the tolerability and preliminary clinical efficacy of linvoseltamab when given in combination with other cancer therapies, aiming to improve care for patients with RRMM.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Journal, Metastases:  Cemiplimab for advanced cutaneous squamous cell carcinoma in kidney transplant recipients. (Pubmed Central) -  Sep 8, 2023   
    Low grade skin toxicity was seen in one patient of the cohort. The present case series shows that the use of cemiplimab in KTR with advanced cSCC who failed to respond to previous surgery, chemo - and/or radiotherapy treatment is associated with an ORR of 42.8% with minimal risk of graft rejection (14.3%) and good tolerance.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Clinical data, Review, Journal, Metastases:  The effect of gender on the clinical outcome of PD-1/PD-L1 inhibitor in advanced lung cancer patients. (Pubmed Central) -  Sep 7, 2023   
    The clinical benefit of PD-1/PD-L1 inhibitors was not statistically significant between males and females during the treatment of lung cancer. In the future, researchers who are designing new immunotherapy studies should ensure a larger inclusion of women in trials, to avoid erroneously extending to women results that are obtained mainly in male patients.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Journal:  Immunogenicity of cemiplimab: low incidence of antidrug antibodies and cut point suitability across tumor types. (Pubmed Central) -  Sep 1, 2023   
    Moreover, no neutralizing antibodies to cemiplimab were detected in patients with ADA-positive samples, and there was no observed impact of cemiplimab ADAs on pharmacokinetics. Study-specific cut points may be required in some diseases such as immune and inflammatory diseases, however, based on this analysis, in-study cut points are not required for each new oncology disease indication for cemiplimab.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Erivedge (vismodegib) / Roche
    Long-standing basal cell carcinoma developed into squamous cell carcinoma. A case report (e-Poster Hall) -  Aug 30, 2023 - Abstract #EADV2023EADV_3304;    
    The current hypothesis regarding the origin of the disease favors a combination of chronic inflammation, immunologic factors, and genetic factors, although the ultimate etiology remains the subject of current research. The surgical approach was excluded, thus we decided to initiate systemic treatment with vismodegib, an inhibitor of the
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Advanced cutaneous SCC: Italian multicentric retrospective analysis of patient profiles and therapeutic approaches (e-Poster Hall) -  Aug 30, 2023 - Abstract #EADV2023EADV_3290;    
    The aim of the present study is to describe clinical characteristics and therapeutic strategies of a real-life Italian cohort of aCSCC patients managed at the beginning of cemiplimab approval as compassionate use in Italy... our study outlines the complex and heterogeneous clinical and therapeutic landscape of aCSCC patients at the beginning of ICI era, highlighting the need of a standardized care for this fragile and high need patient population.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Cancer testis antigens in cutaneous squamous cell carcinomas from patients receiving anti-PD-1 therapy (e-Poster Hall) -  Aug 30, 2023 - Abstract #EADV2023EADV_3285;    
    our study outlines the complex and heterogeneous clinical and therapeutic landscape of aCSCC patients at the beginning of ICI era, highlighting the need of a standardized care for this fragile and high need patient population. Our study focuses on cSCC patients treated with cemiplimab, aiming to compare CTA expression levels in responders and non-responders of the therapy in therapy-na
  • ||||||||||  taladegib (ENV 101) / Roche, Endeavor BioMed
    Metastatic Basal Cell Carcinoma: Treatment with a potentially best in class Hedgehog Inhibitor, Taladegib (e-Poster Hall) -  Aug 30, 2023 - Abstract #EADV2023EADV_3152;    
    Patient was further treated by vismodegib for 12 months followed by Cemiplimab. For the first time we report here that mBCC patients who were refractory to current standard of care treatments responded to taladegib with a duration of response of around one year with fewer and manageable adverse effects.
  • ||||||||||  Immune checkpoint inhibitors-related psoriasis  (e-Poster Hall) -  Aug 30, 2023 - Abstract #EADV2023EADV_2790;    
    There are three distinct groups of ICIs, namely CTLA-4 inhibitors (Ipilimumab and Tremelimumab), PD-1 inhibitors (Nivolumab, Pembrolizumab, and Cemiplimab) and PD-L1 inhibitors (Atezolimumab, Durvalumab and Avelumab),#whose desired effect consists of activating T-lymphocytes, hence stimulating the immune system in order to attack tumor cells. Our aim is to** highlight the importance and the increasing need in knowing how to correctly manage these fragile, often with multiple morbidities, highly prone to immunotherapy-related relapses oncologic patients, keeping in mind the real challenge that is, due to limited therapeutic options as well as the negative impact that almost all dermatologic adverse events have on the quality of life.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
    Journal, Metastases:  PD-1 Inhibitors in Elderly and Immunocompromised Patients with Advanced or Metastatic Cutaneous Squamous Cell Carcinoma. (Pubmed Central) -  Aug 26, 2023   
    The disease control rate was 91.4%, the complete response rate was 17.1%, the partial response rate was 51.4%, the stable disease rate was 23%, and the progressive disease rate was 8.7%. Based on this study, cemiplimab and pembrolizumab for the treatment of locally advanced or metastatic cSCC in elderly, immunocompromised patients are efficacious, with acceptable safety profiles.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Opdivo (nivolumab) / Ono Pharma, BMS
    Scalp Volumetric Modulated Arc Therapy Using 3D Milled Bolus: Dosimetry, Toxicity and Outcome (Hall B2; In Person Only; Screen: 5) -  Aug 22, 2023 - Abstract #ASTRO2023ASTRO_1265;    
    VMAT planning with 3D milled bolus permits technically sound radiotherapy for scalp targets with an acceptable toxicity profile and relatively favorable clinical outcomes. This approach warrants further evaluation in a larger prospective study.
  • ||||||||||  Libtayo (cemiplimab) / Regeneron
    Review, Journal, Metastases:  Cemiplimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma: Appropriate Patient Selection and Perspectives. (Pubmed Central) -  Aug 15, 2023   
    Severe adverse events were primarily immune-mediated, including pneumonitis, myocarditis, myositis, and autoimmune hepatitis; the risk of treatment-related death was 3% in clinical trials. Further research on cemiplimab therapy in cutaneous squamous cell carcinoma is needed, and trials are now underway to obtain Phase IV long-term real-world data, further data on adjuvant and neoadjuvant use, and additional data in special populations such as stem cell and solid organ transplant recipients.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, SAR439459 / Sanofi
    Trial completion date, Trial termination, Trial primary completion date, IO biomarker:  SAR439459 and Cemiplimab for the Treatment of Advanced or Unresectable Solid Tumors, Strategic Alliance, TACTIC TRIAL (clinicaltrials.gov) -  Aug 14, 2023   
    P1b,  N=3, Terminated, 
    Further research on cemiplimab therapy in cutaneous squamous cell carcinoma is needed, and trials are now underway to obtain Phase IV long-term real-world data, further data on adjuvant and neoadjuvant use, and additional data in special populations such as stem cell and solid organ transplant recipients. Trial completion date: Nov 2025 --> Dec 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2025 --> Dec 2022; The industry supporter discontinued the study and lead drug, SAR439459, due to toxicity.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Enrollment change, Trial withdrawal:  Cemiplimab/Peg-Interferon-? in Advanced CSCC (clinicaltrials.gov) -  Aug 9, 2023   
    P1,  N=0, Withdrawn, 
    The scenario analysis showed that when the price of cemiplimab was reduced to less than $184.09/100 N=21 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  Review, Journal, Metastases:  The abscopal effect of immune-radiation therapy in recurrent and metastatic cervical cancer: a narrative review. (Pubmed Central) -  Aug 8, 2023   
    The most recent years have seen the development of the use of immune checkpoint inhibitors (ICIs) (pembrolizumab, cemiplimab and others) in patients with CC...Another emerging drug is tisotumab vedotin, an antibody-drug conjugate targeting tissue factor...Today, there is a growing consensus that combining RT with ICIs may boost abscopal response or cure rates for various cancers. Here we will review the potential abscopal effect of immune-radiation therapy in metastatic cervical cancer.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Paraneoplastic bullous pemphigoid secondary to cutaneous squamous cell carcinoma (e-Poster Hall) -  Aug 8, 2023 - Abstract #EADV2023EADV_1897;    
    It is associated with tissue-bound and circulating autoantibodies directed against BP antigen 180 and BP antigen 230. The diagnosis is based on a combination of criteria encompassing clinical features, compatible light microscopy findings and positive direct immunofluorescence microscopy (DIF) findings.
  • ||||||||||  pegenzileukin (SAR444245) / Sanofi, Libtayo (cemiplimab-rwlc) / Regeneron
    Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date:  Phase 2 Study of Neoadjuvant SAR444245 Plus Cemiplimab in HPV Related Oropharynx Squamous Cell Carcinoma (clinicaltrials.gov) -  Aug 2, 2023   
    P2,  N=0, Withdrawn, 
    Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024 N=26 --> 0 | Trial completion date: Apr 2027 --> Jul 2023 | Suspended --> Withdrawn | Trial primary completion date: Apr 2027 --> Jul 2023
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Dupixent (dupilumab) / Sanofi, Regeneron
    New P2 trial:  PD-1 +/- IL-4 Inhibition in ER+ Breast Cancer (clinicaltrials.gov) -  Aug 1, 2023   
    P2,  N=20, Not yet recruiting,