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


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  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    FDA event, NCCN guideline, Review, Journal, Checkpoint inhibition:  Review of Indications of FDA-Approved Immune Checkpoint Inhibitors per NCCN Guidelines with the Level of Evidence. (Pubmed Central) -  Apr 6, 2020   
    PD-1 inhibitors nivolumab, pembrolizumab, cemiplimab and PD-L1 inhibitors atezolizumab, avelumab, and durvalumab are in the current list of the approved agents in addition to ipilimumab. In this review paper, we discuss the role of each immune checkpoint inhibitor (ICI), the landmark trials which led to their FDA approval, and the strength of the evidence per National Comprehensive Cancer Network (NCCN), which is broadly utilized by medical oncologists and hematologists in their daily practice.
  • ||||||||||  prednisone / Generic mfg., Libtayo (cemiplimab) / Sanofi, Regeneron
    Immune Check Point Inhibitor Associated Endothelialitis () -  Mar 27, 2020 - Abstract #NKFCSM2020NKF_CSM_40;    
    Endothelialitis can be added to spectrum of ICI associated renal pathology. Work up for possible ICI-AKI including serology and kidney biopsy should be strongly considered in this population.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    PK/PD data, Review, Journal, PD(L)-1 Biomarker, IO Biomarker:  Pharmacodynamics of current and emerging PD-1 and PD-L1 inhibitors for the treatment of non-small cell lung cancer. (Pubmed Central) -  Mar 13, 2020   
    However, apart from currently approved, recommended and employed agents (nivolumab, pembrolizumab, atezolizumab, durvalumab), several new agents are currently under development and investigation both in monotherapy and in combinational settings.Areas covered: This paper aims to discuss both the current state of the art and the most interesting emerging PD-1 and PD-L1 inhibitors and their present and future role in metastatic NSCLC treatment.Expert opinion: Great scientific interest lies in combinational settings, involving both already developed FDA and EMA approved and not approved agents and anti PD-1 and PD-L1 inhibitors, that will certainly provide data about pharmacodynamic and clinical properties of these associations, enhancing our understanding of ICIs and cancer immunotherapy. Moreover, new potential predictive biomarkers are much needed, especially considering the less decisive role of PD-L1 in treatment algorithms involving chemo-immune combinations and the current lack of other validated predictive biomarkers.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, REGN4659 / Regeneron
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  Study of REGN4659 in Combination With Cemiplimab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) -  Mar 13, 2020   
    P1,  N=17, Terminated, 
    Moreover, new potential predictive biomarkers are much needed, especially considering the less decisive role of PD-L1 in treatment algorithms involving chemo-immune combinations and the current lack of other validated predictive biomarkers. N=134 --> 17 | Trial completion date: Jun 2021 --> Dec 2019 | Recruiting --> Terminated | Trial primary completion date: Jun 2021 --> Dec 2019; Program reprioritization
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    Monitoring and Incidence of Immune-related Adverse Events (irAEs) () -  Mar 9, 2020 - Abstract #HOPA2020HOPA_317;    
    Patients included are adults 19 years or older that received treatment with ipilimumab, pembrolizumab, nivolumab, cemiplimab, atezolizumab, avelumab, or durvalumab during January 1, 2014 to December 31, 2018. To be determined
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    Evaluating Patient Response to Immunotherapy (anti-PD1/CTLA-4 agents) and Status of Menopause in Melanoma (PRISMM) () -  Mar 9, 2020 - Abstract #HOPA2020HOPA_229;    
    Background/Rationale: First line agents for treatment of melanoma are immunotherapy (ipilimumab, pembrolizumab, and nivolumab)...Exclusion criteria include patients who received cemiplimab, atezolizumab, or durvalumab and pregnant patients... Menopausal status does not appear to impact response, but data may be immature to show a significant difference.
  • ||||||||||  Pexa-Vec (pexastimogene devacirepvec) / SillaJen
    Enrollment change, Trial completion date, Trial primary completion date:  JX594-REN026: A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma (clinicaltrials.gov) -  Mar 2, 2020   
    P1b,  N=116, Recruiting, 
    The parametric and spline-based models were the most common methods for curve fitting, and Gompertz, Weibull, and 2nd order FPs were the most common methods for conducting NMA in case of PH violation. N=89 --> 116 | Trial completion date: Sep 2020 --> Nov 2023 | Trial primary completion date: Nov 2019 --> Aug 2022
  • ||||||||||  ISA101 / ISA Pharma
    Trial completion date, Trial primary completion date:  OpcemISA: A Randomized Phase 2 Study of Cemiplimab  (clinicaltrials.gov) -  Jan 31, 2020   
    P2,  N=194, Recruiting, 
    N=22 --> 44 | Trial completion date: Jan 2020 --> Jul 2021 | Trial primary completion date: Jan 2020 --> Jul 2021 Trial completion date: Feb 2022 --> Nov 2022 | Trial primary completion date: Feb 2020 --> Nov 2020
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Trial completion:  Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies (clinicaltrials.gov) -  Jan 27, 2020   
    P1,  N=398, Completed, 
    Prospective clinical trials are needed to assess the outcomes of this treatment modalit Active, not recruiting --> Completed
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    Serio - Side Effect Registry in Immuno-Oncology (atrium) -  Jan 25, 2020 - Abstract #DKK2020DKK_2436;    
    Shared experiences will enable better management of side effects and better patient information with regard to outcome of side effects thus reducing patient morbidity and mortality. Eventually, it will enable to better understand pathogenesis and prediction of irAEs.
  • ||||||||||  Libtayo (cemiplimab) / Sanofi, Regeneron
    Journal, Checkpoint inhibition, Tumor Mutational Burden, PD(L)-1 Biomarker, IO biomarker:  Immune Checkpoint Inhibitors for Treating Advanced Cutaneous Squamous Cell Carcinoma. (Pubmed Central) -  Jan 23, 2020   
    Compared to prior systemic therapies with scant data for efficacy and safety, cemiplimab is a breakthrough therapy, the first systemic drug approved for advanced CSCCs. Other immune checkpoint inhibitors have shown promise through case reports and series, and are currently in clinical development for CSCCs.
  • ||||||||||  Biomarker, Trial primary completion date, PARP Biomarker, PD(L)-1 Biomarker:  I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) -  Jan 22, 2020   
    P2,  N=1920, Recruiting, 
    Other immune checkpoint inhibitors have shown promise through case reports and series, and are currently in clinical development for CSCCs. Trial primary completion date: Dec 2020 --> Dec 2025
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Trial primary completion date:  EMPOWER-Cervical 1: Study of Cemiplimab in Adults With Cervical Cancer (clinicaltrials.gov) -  Jan 14, 2020   
    P3,  N=534, Recruiting, 
    Trial completion date: Dec 2022 --> Aug 2022 Trial primary completion date: Apr 2023 --> May 2021
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Journal:  Systemic therapy for advanced cutaneous squamous cell carcinoma. (Pubmed Central) -  Dec 23, 2019   
    Despite these advances, the preferred regimen for systemic treatment of cSCC remains unclear, particularly in immunocompromised populations. Herein we provide a review of the literature supporting the use of these modalities and a discussion of their clinical utility.