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


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  • ||||||||||  Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
    Review, Journal:  The Role of Systemic Therapy in Advanced Cutaneous Squamous Cell Carcinoma. (Pubmed Central) -  Nov 29, 2021   
    Adjuvant postoperative chemoradiation with platinum has been called into question based on recent data. Programmed cell death protein 1 receptor immune checkpoint inhibitors have demonstrated profound activity in HNCSCC, and cemiplimab and pembrolizumab now are approved for use for unresectable/metastatic disease.
  • ||||||||||  Libtayo (cemiplimab) / Sanofi, Regeneron
    RESPONSE TO CEMIPLIMAB IN SYNCHRONOUS METASTATIC PLEOMORPHIC DERMAL SARCOMA AND SQUAMOUS CELL CARCINOMA OF THE SKIN ([VIRTUAL]) -  Nov 26, 2021 - Abstract #CTOS2021CTOS_174;    
    There are few reports of efficacy, however, and no prospective data establishes the best systemic treatment in the context of locally advanced, recurrent or metastatic disease, although there are reports of successful treatment with immune checkpoint inhibitors. This case report illustrates the clinical response of a patient with two metastatic primary synchronic skin tumors to distant lymph nodes when treated with cemiplimab in the first line, in view of being a therapeutic option with significant activity for metastatic skin SCC and with potential activity for metastatic PDS.
  • ||||||||||  Libtayo (cemiplimab) / Sanofi, Regeneron, Sarclisa (isatuximab-irfc) / Sanofi
    A Phase 1/2, Open-Label, Multicenter Study of Isatuximab in Combination with Cemiplimab in Patients with Lymphoma () -  Nov 24, 2021 - Abstract #ASH2021ASH_6763;    
    P1/2
    Clinical efficacy was observed in pts with cHL, with increased responses observed in pts who had not previously received anti-PD-1/PD-L1 therapy compared with those who progressed on anti-PD-1/PD-L1 therapy. For Cohorts B (DLBCL) and C (PTCL), results of the interim efficacy analysis did not meet prespecified criteria to continue enrollment in Phase 2 Stage 2.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Trial completion date, Trial primary completion date:  Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC) (clinicaltrials.gov) -  Nov 24, 2021   
    P2,  N=44, Not yet recruiting, 
    For Cohorts B (DLBCL) and C (PTCL), results of the interim efficacy analysis did not meet prespecified criteria to continue enrollment in Phase 2 Stage 2. Trial completion date: Jun 2025 --> Jan 2025 | Trial primary completion date: Jun 2025 --> Jan 2025
  • ||||||||||  Libtayo (cemiplimab) / Sanofi, Regeneron
    Clinical, Journal:  IsAb: a computational protocol for antibody design. (Pubmed Central) -  Nov 24, 2021   
    As a proof of concept, we redesigned antibody D44.1 and compared it with previously reported data in order to validate IsAb protocol. To further illustrate our proposed protocol, we used cemiplimab antibody, a PD-1 checkpoint inhibitor, as an example to showcase a step-by-step tutorial.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Trial completion, IO biomarker:  EMPOWER-lung 4: A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer (clinicaltrials.gov) -  Nov 17, 2021   
    P2,  N=28, Completed, 
    This meta-analysis confirmed that anti-PD-1 and anti-PD-L1 inhibitors had a lower incidence of irAEs compared with anti-CTLA-4 inhibitors. Active, not recruiting --> Completed
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    Final Results of Controlled IL-12 Monotherapy and in Combination with PD-1 inhibitor in Adult Subjects with Recurrent Glioblastoma (Exhibit Hall D) -  Nov 16, 2021 - Abstract #SNO2021SNO_332;    
    P1, P2
    Ad-RTS-hIL-12(Ad) is a gene therapy candidate conditionally expressing IL-12 under the transcriptional control of veledimex(V) acting via the RheoSwitch Therapeutic System® gene switch...Ziopharm has conducted 3 phase-I (NCT02026271/NCT03679754 (monotherapy), NCT03636477 (combination with nivolumab)) and one phase-ll (NCT04006119) multicenter, open-label, single-arm trial in subjects with rGBM is evaluating Ad (single intratumoral injection, 2 x 10 11 -viral-particles, Day0) with oral V dosing (20mg, Days 0-14) with cemiplimab infusions (350 mg IV) on Days -7, 15, then Q3W...Final survival data and results from neoepitope analysis will be presented. Further investigation is warranted to understand the impact of monotherapy vs. combination, concurrent steroids use and unifocal vs. multifocal disease on overall survival in subjects with rGBM receiving Controlled-IL-12.
  • ||||||||||  ASP8374 / Astellas
    Trial initiation date:  ASP8374 + Cemiplimab in Recurrent Glioma (clinicaltrials.gov) -  Nov 15, 2021   
    P1,  N=65, Not yet recruiting, 
    Further investigation is warranted to understand the impact of monotherapy vs. combination, concurrent steroids use and unifocal vs. multifocal disease on overall survival in subjects with rGBM receiving Controlled-IL-12. Initiation date: Sep 2021 --> Dec 2021
  • ||||||||||  Libtayo (cemiplimab) / Sanofi, Regeneron
    Clinical, Journal, Real-world evidence:  Real world safety outcomes using cemiplimab for cutaneous squamous cell carcinoma. (Pubmed Central) -  Oct 27, 2021   
    Prospective comparison may be warranted. In our cohort, safety seemed to be worse than in phase II trial with more treatment discontinuations due to cemiplimab toxicity, probably reflecting the distinct demographic and medical characteristics of patients in daily care.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    Journal, Adverse events, Checkpoint inhibition:  Cutaneous Immune-Related Adverse Events (irAEs) to Immune Checkpoint Inhibitors: A Dermatology Perspective on Management. (Pubmed Central) -  Oct 22, 2021   
    There is limited literature available on the management of the cutaneous irAEs and most studies present anecdotal evidence. We review the management strategies and provide recommendations for psoriatic, immunobullous, maculopapular, lichenoid, acantholytic eruptions, vitiligo, alopecias, vasculitides, SJS/toxic epidermal necrolysis, and other related skin toxicities.
  • ||||||||||  Libtayo (cemiplimab) / Sanofi, Regeneron
    Journal:  Cemiplimab removed from reimbursable drugs in France. (Pubmed Central) -  Oct 22, 2021   
    We review the management strategies and provide recommendations for psoriatic, immunobullous, maculopapular, lichenoid, acantholytic eruptions, vitiligo, alopecias, vasculitides, SJS/toxic epidermal necrolysis, and other related skin toxicities. No abstract available
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Enrollment change, Trial completion date, Trial primary completion date:  CASE: CemiplimAb Survivorship Epidemiology (clinicaltrials.gov) -  Oct 8, 2021   
    P=N/A,  N=500, Recruiting, 
    Not yet recruiting --> Recruiting N=350 --> 500 | Trial completion date: Dec 2023 --> Sep 2025 | Trial primary completion date: Dec 2023 --> Sep 2025
  • ||||||||||  Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD), Tecentriq (atezolizumab) / Roche
    Telomerase-Driven Telomeric DNA Modification in Cancer Cells Leads to Efficient Induction of cGAS-mediated Innate and Adoptive Immune Responses (Poster Hall) -  Oct 1, 2021 - Abstract #SITC2021SITC_533;    
    Combinations with other immune checkpoint inhibitors (cemiplimab; pembrolizumab) were also highly effective Conclusions In summary, our findings demonstrate the importance of cancer cell telomeric DNA structural and functional integrity, as well as a therapeutically attractive opportunity to induce telomerase-mediated telomere replication stress. THIO modified telomeres increase innate sensing and adaptive antitumor immunity via “cancer cell self-produced” chemical modification of telomeres.
  • ||||||||||  Libtayo (cemiplimab) / Sanofi, Regeneron, Opdivo (nivolumab) / Ono Pharma, BMS, vusolimogene oderparepvec (RP1) / Replimune
    CERPASS: A randomized, controlled, open-label, phase 2 study of cemiplimab ± RP1 in patients with advanced cutaneous squamous cell carcinoma (Poster Hall) -  Oct 1, 2021 - Abstract #SITC2021SITC_466;    
    P2
    In preclinical studies, RP1 induced immunogenic tumor cell death and provided potent systemic anti-tumor activity, which is further improved by combining anti-PD-1 therapy.3 Preliminary results from IGNYTE, a phase I/II clinical study of RP1 in combination with nivolumab showed a high rate of deep and durable responses in patients (pts) with CSCC.4 The objective of this trial is to evaluate the safety and efficacy of cemiplimab + RP1 versus cemiplimab alone in advanced CSCC...This trial is currently enrolling pts. Trial Registration NCT04050436
  • ||||||||||  Libtayo (cemiplimab) / Sanofi, Regeneron, Avastin (bevacizumab) / Roche
    Phase 3 recurrent/metastatic cervical carcinoma trial: subgroup efficacy analysis of cemiplimab versus individual investigator’s choice chemotherapy () -  Oct 1, 2021 - Abstract #ESGO2021ESGO_433;    
    P3
    Adult females (age ≥18 years) were enrolled regardless of PD-ligand 1 expression and received cemiplimab 350 mg intravenously every 3 weeks or IC chemotherapy for up to 96 weeks; and were stratified by histology (squamous cell carcinoma/adenocarcinoma or adenosquamous), geographic region (North America/Asia/rest of world), prior bevacizumab, and ECOG performance status (0/1)...OS, PFS and ORR ( table 1 ) demonstrated improvements with cemiplimab vs each IC chemotherapy treatment similar to those observed with cemiplimab vs pooled IC chemotherapy. View this table: View inline View popup Download powerpoint Abstract 164 Table 1 Conclusion* Improvements in OS, PFS and ORR with cemiplimab trended consistently with the results for the overall population regardless of IC chemotherapy drug.