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


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  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Review, Journal:  Multidisciplinary management of locally advanced and metastatic cutaneous squamous cell carcinoma. (Pubmed Central) -  Jun 8, 2021   
    A new systemic therapy, cemiplimab, has been approved for the treatment of locally advanced and metastatic cscc. In the present review, we provide recommendations for patient classification and staging based on current guidelines, direction for determining patient eligibility for surgery and rt, and an overview of the available systemic treatment options for advanced cscc and of the benefits of a multidisciplinary approach to patient management.
  • ||||||||||  Avastin (bevacizumab) / Roche, Opdivo (nivolumab) / Ono Pharma, BMS
    [VIRTUAL] Long-Term Management of Metastatic NSCLC without a Targetable Tumor Mutation () -  Jun 5, 2021 - Abstract #ASCO2021ASCO_5883;    
    In the present review, we provide recommendations for patient classification and staging based on current guidelines, direction for determining patient eligibility for surgery and rt, and an overview of the available systemic treatment options for advanced cscc and of the benefits of a multidisciplinary approach to patient management. Published efficacy and safety outcomes from the Phase III trial of cemiplimab monotherapy versus chemotherapy as first-line treatment for patients with PD-L1-positive locally advanced or metastatic NSCLC; recent FDA approval of cemiplimab and optimal integration into current clinical management Clinical trial database supporting the FDA approvals of pembrolizumab and atezolizumab administered as monotherapy and combined with chemotherapy as first-line treatment for metastatic NSCLC Updated results from the Phase III CheckMate 9LA and CheckMate 227 trials leading to the FDA approvals of first-line nivolumab/ ipilimumab with and without chemotherapy for patients with metastatic NSCLC Recently presented findings from the Phase III KEYNOTE-598 trial revealing a lack of benefit with ipilimumab in combination with pembrolizumab versus pembrolizumab alone as first-line therapy for patients with PD-L1-positive (TPS ≥50%) metastatic NSCLC Clinical and biologic factors affecting the selection of anti-PD-1/PD-L1 monotherapy versus combined chemoimmunotherapy or dual immune checkpoint inhibition for patients with nonsquamous and squamous metastatic NSCLC Rationale for the design of the ongoing Phase III KEYLYNK-008 trial of pembrolizumab in combination with chemotherapy followed by pembrolizumab with or without maintenance olaparib in the first-line treatment of squamous metastatic NSCLC Management of disease that has progressed on anti-PD-1/PD-L1-based therapy in the first-line setting; current role of approved agents and regimens (eg, ramucirumab, afatinib, bevacizumab) Mechanisms of action of tislelizumab and ociperlimab; ongoing Phase III trial comparing tislelizumab/ociperlimab to single-agent pembrolizumab or ociperlimab as first-line therapy for patients with PD-L1-selected unresectable, locally advanced or metastatic NSCLC Other novel immune checkpoint inhibitor-based combination strategies (eg, co-formulated vibostolimab with pembrolizumab) under investigation for patients with metastatic NSCLC Mechanism of action of sintilimab; ongoing Phase II SUCCESS trial of sintilimab in combination with docetaxel for previously treated, locally advanced or metastatic NSCLC Ongoing Phase III trials evaluating immunotherapy-based combinations for patients with previously untreated or pretreated metastatic NSCLC (eg, ZEAL-1L, LEAP-008)
  • ||||||||||  [VIRTUAL] Cervical Cancer (CC) () -  Jun 5, 2021 - Abstract #ASCO2021ASCO_5877;    
    Published efficacy and safety outcomes from the Phase III trial of cemiplimab monotherapy versus chemotherapy as first-line treatment for patients with PD-L1-positive locally advanced or metastatic NSCLC; recent FDA approval of cemiplimab and optimal integration into current clinical management Clinical trial database supporting the FDA approvals of pembrolizumab and atezolizumab administered as monotherapy and combined with chemotherapy as first-line treatment for metastatic NSCLC Updated results from the Phase III CheckMate 9LA and CheckMate 227 trials leading to the FDA approvals of first-line nivolumab/ ipilimumab with and without chemotherapy for patients with metastatic NSCLC Recently presented findings from the Phase III KEYNOTE-598 trial revealing a lack of benefit with ipilimumab in combination with pembrolizumab versus pembrolizumab alone as first-line therapy for patients with PD-L1-positive (TPS ≥50%) metastatic NSCLC Clinical and biologic factors affecting the selection of anti-PD-1/PD-L1 monotherapy versus combined chemoimmunotherapy or dual immune checkpoint inhibition for patients with nonsquamous and squamous metastatic NSCLC Rationale for the design of the ongoing Phase III KEYLYNK-008 trial of pembrolizumab in combination with chemotherapy followed by pembrolizumab with or without maintenance olaparib in the first-line treatment of squamous metastatic NSCLC Management of disease that has progressed on anti-PD-1/PD-L1-based therapy in the first-line setting; current role of approved agents and regimens (eg, ramucirumab, afatinib, bevacizumab) Mechanisms of action of tislelizumab and ociperlimab; ongoing Phase III trial comparing tislelizumab/ociperlimab to single-agent pembrolizumab or ociperlimab as first-line therapy for patients with PD-L1-selected unresectable, locally advanced or metastatic NSCLC Other novel immune checkpoint inhibitor-based combination strategies (eg, co-formulated vibostolimab with pembrolizumab) under investigation for patients with metastatic NSCLC Mechanism of action of sintilimab; ongoing Phase II SUCCESS trial of sintilimab in combination with docetaxel for previously treated, locally advanced or metastatic NSCLC Ongoing Phase III trials evaluating immunotherapy-based combinations for patients with previously untreated or pretreated metastatic NSCLC (eg, ZEAL-1L, LEAP-008) Current indications for and timing of PD-L1 testing for patients with advanced CC; definition of PD-L1 positivity based on the combined positive score and its implications for treatment decision-making Available research data with pembrolizumab for patients with recurrent CC; impact of PD-L1 positivity on outcomes FDA approval of pembrolizumab for advanced CC; patient selection and integration into clinical algorithms Spectrum and management of toxicities with pembrolizumab for CC Design, eligibility criteria and key efficacy and safety endpoints of the Phase III EMPOWER Cervical-1 trial evaluating cemiplimab versus investigator’s choice of chemotherapy for platinum-refractory metastatic CC Incidence and severity of toxicities reported with cemiplimab in the EMPOWER Cervical-1 trial Biologic rationale for combining immune checkpoint inhibitors with agents targeting the VEGF pathway Response rates, efficacy and safety data with the combination of balstilimab and zalifrelimab for metastatic CC; FDA fast track designation and potential clinical role for this regimen Design, eligibility criteria and key efficacy and safety endpoints of ongoing trials evaluating anti-PD-1/PD-L1 antibodies for advanced CC (eg, CALLA, KEYNOTE-826) Available clinical research data with tisotumab vedotin for relapsed/refractory CC (innovaTV 201 trial); FDA priority review status and potential clinical role Spectrum and incidence of adverse events with tisotumab vedotin; recommended algorithms for the prevention and management of ocular side effects Design, eligibility criteria, and key efficacy and safety endpoints being evaluated in the pivotal Phase II innovaTV 204 study of tisotumab vedotin monotherapy for recurrent and/or metastatic CC; other ongoing research with tisotumab vedotin
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    [VIRTUAL] What General Medical Oncologists Want to Know About Immunotherapy and Other Nontargeted Approaches for Lung Cancer () -  Jun 5, 2021 - Abstract #ASCO2021ASCO_5845;    
    Recognize the recent FDA approvals of nivolumab in combination with ipilimumab with and without chemotherapy as first-line treatment for patients with metastatic NSCLC, and appropriately incorporate these novel regimens into current treatment algorithms. Review recent therapeutic advances related to the use of anti-PD-1/PD-L1 antibodies as monotherapy or in combination with chemotherapy or chemobiologic therapy for metastatic NSCLC, and discern how these approaches can be optimally employed in the management of this disease.
  • ||||||||||  REGN6569 / Regeneron, Libtayo (cemiplimab-rwlc) / Regeneron
    Enrollment open, Trial completion date, Trial primary completion date, Metastases:  Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov) -  Jun 2, 2021   
    P1,  N=85, Recruiting, 
    Trial completion date: Jun 2021 --> Dec 2021 | Trial primary completion date: Jun 2021 --> Dec 2021 Suspended --> Recruiting | Trial completion date: Oct 2025 --> Jun 2026 | Trial primary completion date: Oct 2025 --> Jun 2026
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    Journal, Checkpoint inhibition:  Psoriasis and psoriasiform reactions secondary to Immune Checkpoint Inhibitors. (Pubmed Central) -  May 26, 2021   
    ICIs-related skin toxicity is a well-established phenomenon, presenting with several conditions, sustained by an immune background based on the activity of some cells (CD4+/CD8+ T-cells, neutrophils, eosinophils, plasmocytes), inflammatory mediators, chemokines and tumor-specific antibodies. In this setting, psoriasis represents probably the most paradigmatic model of these reactions, thus requiring adequate recognition as no guidelines on management are now available.
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Review, Journal:  Molecular genetics of cutaneous squamous cell carcinoma: perspective for treatment strategies. (Pubmed Central) -  May 15, 2021   
    This review focuses on molecular findings involved in the pathogenesis of cSCC and their implications for the future development of new treatment strategies. In addition, current and ongoing treatments on targeted therapies and/or immunotherapy are illustrated.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    Review, Journal:  Pattern of response of unresectable and metastatic cutaneous squamous cell carcinoma to Programmed death-1 inhibitors: a review of the literature. (Pubmed Central) -  May 15, 2021   
    Programmed death-1 (PD-1) inhibitors (pembrolizumab, nivolumab, and cemiplimab) are an innovative immunologic treatment that now has been shown to be useful for the treatment of advanced cSCC...Moreover, the number of cases is too small to express the beneficial effects of these treatments, although most data reported in literature show quite good response rates. This review focused on some of the studies and associated results through an interesting research on search engines of all the cases about these systemic drugs, analyzing effects and side effects and the research has been conducted considering published cases since March 2016 to October 2019.
  • ||||||||||  Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
    [VIRTUAL] A Virtual CSCC Case Challenge () -  May 8, 2021 - Abstract #ASCO2021ASCO_5718;    
    The virtual audience will be uniquely engaged in a case-based simulation (ie, MedSims) and will control the direction of their journey at key decision points (assessment, diagnosis, and treatment) . Audience polling will be used to vote on clinical actions, such as ordering tests, choosing a diagnosis, and selecting treatment.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    New P2 trial, Metastases:  Cemiplimab for Secondary Angiosarcomas (clinicaltrials.gov) -  May 4, 2021   
    P2,  N=18, Not yet recruiting, 
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
    [VIRTUAL] Online CME closes gaps in CSCC management revealed in a virtual patient simulation. () -  Apr 29, 2021 - Abstract #ASCO2021ASCO_5543;    
    These results demonstrate the effectiveness of curriculum-based education for oncologists to address specific gaps in care as identified in a virtual patient simulation . This series of CME-certified online educational activities resulted in significant improvements in knowledge and competence in the assessment and treatment of patients with CSCC.