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


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  • ||||||||||  Odomzo (sonidegib) / Sun Pharma, Libtayo (cemiplimab-rwlc) / Regeneron, Erivedge (vismodegib) / Roche
    Review, Journal, Metastases:  Immunotherapy and Its Timing in Advanced Basal Cell Carcinoma Treatment. (Pubmed Central) -  Nov 22, 2023   
    In this review, we revisit the therapeutic decisions considering a switch from HHI to immunotherapy with anti-PD-1 agent cemiplimab and we highlight the place of cemiplimab in the therapeutic ladder for patients with advanced BCC. We discuss the evidence on the efficacy and safety of anti-PD-1 agents as second-line systemic monotherapy, or in combination with other treatments, and the emergence of checkpoint immunotherapy as a neoadjuvant treatment.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
    Review, Journal, Metastases:  Advanced Cutaneous Squamous Cell Carcinoma Management in Immunotherapy Era: Achievements and New Challenges. (Pubmed Central) -  Nov 22, 2023   
    Several questions related to the activity and the safety of immunotherapy in the real-world setting still remain without answer, and several points need to be better explored. In the current review we will explore the updated literature on the use of immunotherapy in cSCC, and we will show the current challenges in its use.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Enrollment change, Trial completion date, Trial primary completion date:  Intralesional Cemiplimab for Adult Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma (clinicaltrials.gov) -  Nov 22, 2023   
    P1,  N=109, Recruiting, 
    In the current review we will explore the updated literature on the use of immunotherapy in cSCC, and we will show the current challenges in its use. N=61 --> 109 | Trial completion date: Jan 2024 --> Nov 2027 | Trial primary completion date: Oct 2023 --> Sep 2027
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Trial completion, Trial primary completion date:  EMPOWER-CSCC-1 : Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) -  Nov 18, 2023   
    P2,  N=432, Completed, 
    N=61 --> 109 | Trial completion date: Jan 2024 --> Nov 2027 | Trial primary completion date: Oct 2023 --> Sep 2027 Active, not recruiting --> Completed | Trial primary completion date: Oct 2023 --> Apr 2023
  • ||||||||||  Journal, Adverse events, Checkpoint inhibition:  Survival Among Veterans Receiving Steroids for Immune-Related Adverse Events After Immune Checkpoint Inhibitor Therapy. (Pubmed Central) -  Nov 4, 2023   
    Eligible patients in the steroid group received at least 1 dose (intravenous, intramuscular, or oral) of dexamethasone, hydrocortisone, methylprednisolone, prednisone, or prednisolone...This study suggests that steroids for irAE management may not abrogate irAE-associated survival benefits. However, early steroid administration within 2 months of ICI initiation is associated with shorter survival despite continuation of ICI therapy.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Enrollment closed:  CASE: CemiplimAb Survivorship Epidemiology (clinicaltrials.gov) -  Oct 30, 2023   
    P=N/A,  N=287, Active, not recruiting, 
    Trial primary completion date: Dec 2023 --> Dec 2024 Recruiting --> Active, not recruiting
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Enrollment open, IO biomarker:  DISCERN: Deep sequencIng in Cutaneous Squamous CEll caRciNomas (clinicaltrials.gov) -  Oct 27, 2023   
    P2,  N=10, Recruiting, 
    Suspended --> Recruiting Not yet recruiting --> Recruiting
  • ||||||||||  BNT112 / BioNTech
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Monotherapy:  PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy) (clinicaltrials.gov) -  Oct 25, 2023   
    P1/2,  N=75, Active, not recruiting, 
    Baseline tumor load (i.e., MTV and TLG) and metabolic response at 12 weeks may have a prognostic impact in cSCC patients treated with cemiplimab. Recruiting --> Active, not recruiting | N=115 --> 75 | Trial completion date: Jul 2023 --> Oct 2024 | Trial primary completion date: Jul 2023 --> Jan 2024
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Opdivo (nivolumab) / Ono Pharma, BMS
    Journal:  Scalp Volumetric Modulated Arc Therapy Using 3D Milled Bolus: Dosimetry, Toxicity and Outcome. (Pubmed Central) -  Oct 3, 2023   
    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-rwlc) / Regeneron
    Enrollment change:  CASE: CemiplimAb Survivorship Epidemiology (clinicaltrials.gov) -  Oct 1, 2023   
    P=N/A,  N=300, Recruiting, 
    Recruiting --> Active, not recruiting N=500 --> 300
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Infliximab for decompensated diabetes following immune checkpoint inhibitor therapy (Exhibit Hall B) -  Sep 27, 2023 - Abstract #SITC2023SITC_1569;    
    Results A 71-year-old man with metastatic squamous cell carcinoma of the jaw and a history of diet-controlled diabetes acutely developed weight loss, polyuria, and polydipsia with a rise of his serum glucose to 398 mg/dL following a 9th dose of cemiplimab, an anti PD-1 monoclonal antibody...At seven months of follow-up, he continued on metformin and dulaglutide with a hemoglobin A1C of 5...If true, this would save patients substantial morbidity. We believe this preliminary data warrants further study including randomized controlled trials.
  • ||||||||||  Safety of Immune checkpoint inhibitors in elderly patients over 75 years (Exhibit Hall B) -  Sep 27, 2023 - Abstract #SITC2023SITC_1533;    
    Conclusions Our study demonstrates that elderly patients with cancer who receive ICI treatment are not at increased risk of irAE compared to younger patients. These findings suggest that age alone should not preclude older adults from receiving ICI therapy, and that these treatments can be safely and effectively used in older adults.
  • ||||||||||  Safety of immune checkpoint inhibitors in cancer patients with HIV  (Exhibit Hall B) -  Sep 27, 2023 - Abstract #SITC2023SITC_809;    
    Conclusions Our study demonstrates that HIV patients who receive ICI treatment have similar risk of irAE compared to non-HIV patients, indicating that ICI treatment is safe in this population. Eligibility criteria for clinical trials should be expanded to include HIV patients to improve health outcomes in this population.