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


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  • ||||||||||  IMMUNE-RELATED ADVERSE EVENTS FOLLOWING IMMUNE CHECKPOINT INHIBITORS IN PATIENTS WITH HEPATOCELLULAR CARCINOMA (ePoster - DDW Online Platform) -  Mar 23, 2023 - Abstract #DDW2023DDW_639;    
    Of the included patients, 8,582 (1.7%) patients received ICIs, whereas 496,709 (98.3%) did not receive ICIs. Within one year follow-up, patients who received ICIs was associated with increased new onset immune-related side effects, including hypopituitarism (HR, 7.31; 95% CI, 4.49-11.92, P<0.01), hypothyroidism (HR, 6.18; 95% CI, 5.65-6.76, P<0.01), hyperthyroidism (HR, 5.55; 95% CI, 4.56-6.75, P<0.01), Cushing syndrome (HR, 2.81; 95% CI, 1.39-5.72, P<0.01), myocarditis (HR, 4.68; 95% CI, 3.11-7.03, P<0.01), pneumonitis (HR, 2.16; 95% CI, 1.83-2.55, P< 0.01), pleural plaque (HR, 6.19; 95% CI, 4.92-7.79, P<0.01), pleural effusion (HR, 3.60; 95% CI, 3.10-4.19, P<0.01), ulcerative colitis (HR, 2.38; 95% CI, 1.66-3.41, P<0.01), Crohn's disease (HR, 1.79; 95% CI, 1.25-2.56, P<0.01), gastroenteritis (HR, 3.50; 95% CI, 3.17-3.86, P<0.01), vitiligo (HR, 3.90; 95% CI, 2.62-5.80, P<0.01) and primary adrenal insufficiency (HR, 7.61; 95% CI, 5.21-11.12, P<0.01).
  • ||||||||||  Libtayo (cemiplimab) / Regeneron
    Frequent discordance in PD-L1 and PD-L2 protein expression in breast cancer (Exhibition area) -  Mar 22, 2023 - Abstract #ESMOBC2023ESMO_BC_340;    
    P2
    Clinical trial identification Tumor specimens from diagnostic core biopsies from our ongoing phase II clinical trial (NCT04243616) of neoadjuvant chemotherapy and PD-1 inhibitor (cemiplimab; Regeneron Pharmaceuticals Inc) were used for these analyses Legal entity responsible for the study The authors...Discordant PD-L2 and PD-L1 expression may be more common in ER+ BC than in TNBC. This progress justifies efforts to explore PD-L2 as a complementary marker to PD-L1 for improved prediction of responses to PD-1 inhibitors, which may also benefit pts with aggressive ER+ BC.
  • ||||||||||  HST-1011 / HotSpot Therap
    Phase 1/2 study of HST-1011, an oral CBL-B inhibitor, alone and in combination with anti-PD1 in patients with advanced solid tumors (Section 46; Poster Board #14) -  Mar 14, 2023 - Abstract #AACR2023AACR_7140;    
    P1/2
    Ph1, Part B: HST-1011 dose escalation in combination with cemiplimab, as in Part A1 with a BOIN design and optional dosing cohorts.Biomarkers: Target engagement and PD will be assessed via a) serial monitoring of cytokines/chemokines and transcriptional profiles; b) peripheral immune cell profiling; and c) in-depth analysis of screening and on-treatment tumor biopsies. The study is open with competitive enrollment.
  • ||||||||||  Libtayo (cemiplimab) / Regeneron, fianlimab (REGN3767) / Regeneron, Sanofi
    LAG-3 PET imaging in patients with cancer before immune checkpoint inhibitor therapy (Section 42; Poster Board #2) -  Mar 14, 2023 - Abstract #AACR2023AACR_7097;    
    P1/2
    Optimal imaging results were achieved with the 40 mg protein dose and imaging on day 7. 89Zr-DFO-REGN3767 shows specific accumulation in LAG-3 rich tissues and tumor lesions.
  • ||||||||||  Total toxicity burden of FDA approved immune checkpoint inhibitors in USA (Section 38; Poster Board #30) -  Mar 14, 2023 - Abstract #AACR2023AACR_5853;    
    There are risks of respiratory and urinary system toxicity in male patients and reproductive system toxicity in female patients when they receive the treatment of ICIs. Studies such as this one provide the statistical data for understanding patients at risk of developing irAEs, which will underscore the importance of further exploring research strategies to predict, detect, and mitigate toxicities from ICIs.
  • ||||||||||  Libtayo (cemiplimab) / Regeneron
    Fast de novo antibody structure prediction with atomic accuracy (Section 32; Poster Board #27) -  Mar 14, 2023 - Abstract #AACR2023AACR_5743;    
    Its improvement on both accuracy and efficiency makes it a valuable tool for de novo antibody design, and could make further improvement in immuno-theory. Experimental results on immune antibody dataset with 95% confidence interval.MethodRMSDTMScoreGDTTSGDTHAAlphaFold23.1254
  • ||||||||||  Sarclisa (isatuximab-irfc) / Sanofi
    Trial termination:  A Study of Isatuximab-based Therapy in Participants With Lymphoma (clinicaltrials.gov) -  Mar 14, 2023   
    P1/2,  N=58, Terminated, 
    Completed --> Terminated; Study was stopped after interim analysis for all 4 cohorts with results either not fulfilling the pre-planned interim analysis criteria or fulfilling the criteria but as per sponsor decision. It was not due to any safety concern
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Trial completion date, Trial primary completion date:  Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer (clinicaltrials.gov) -  Mar 9, 2023   
    P2,  N=25, Active, not recruiting, 
    Trial completion date: Oct 2029 --> Feb 2030 | Trial primary completion date: Oct 2029 --> Feb 2030 Trial completion date: Sep 2023 --> May 2023 | Trial primary completion date: Sep 2023 --> May 2023
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Enrollment closed:  Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer (clinicaltrials.gov) -  Mar 8, 2023   
    P2,  N=25, Active, not recruiting, 
    Further research is required on utilities of Japanese patients with recurrent cervical cancer. Recruiting --> Active, not recruiting
  • ||||||||||  Stelara (ustekinumab) / J&J, Libtayo (cemiplimab) / Regeneron, Dupixent (dupilumab) / Sanofi, Regeneron
    Immune profiling of immune checkpoint inhibitor-induced lichen planus and vitiligo in the setting of pathogenesis-directed therapy () -  Mar 4, 2023 - Abstract #ISID2023ISID_1687;    
    We report the immune profile of ICI-induced lichen planus (LP) and vitiligo in a prostate cancer patient on cemiplimab...Given these findings, the patient received ustekinumab for Th1/Th17 blockade and dupilumab for Th2 blockade...This case provides insights into the immunophenotypes of ICI-induced LP and vitiligo, and explores the potential for treatment of cirAEs with pathogenesis-directed therapy. Further study of potential immune profile differences between cirAEs and their idiopathic counterparts is warranted.
  • ||||||||||  Libtayo (cemiplimab) / Regeneron
    Review, Journal, Cytokine release syndrome:  Cemiplimab-induced cytokine-release syndrome: second case reported and review of the literature. (Pubmed Central) -  Feb 27, 2023   
    The authors report the case of a 62-year-old treated by cemiplimab for a cutaneous squamous-cell carcinoma of the diaper fold with iliac and inguinal lymph node extension. He presented with severe cytokine-release syndrome, concluding with the discontinuation of cemiplimab.
  • ||||||||||  Libtayo (cemiplimab) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
    Journal, Checkpoint inhibition:  Immune checkpoint inhibitors for treatment of periorbital squamous cell carcinoma. (Pubmed Central) -  Feb 27, 2023   
    He presented with severe cytokine-release syndrome, concluding with the discontinuation of cemiplimab. Our findings support the emerging role of anti-PD-1 immunotherapy in the management of locally advanced periorbital cutaneous squamous cell carcinoma.
  • ||||||||||  Retrospective data, Journal:  Treatments for brain metastases from EGFR/ALK-negative/unselected NSCLC: A network meta-analysis. (Pubmed Central) -  Feb 23, 2023   
    For newly diagnosed BMs, adding chemotherapy, EGFR-TKIs, and other innovative systemic agents (temozolomide, nitroglycerin, endostar, enzastaurin, and veliparib) to radiotherapy did not significantly prolong OS than radiotherapy alone; whereas radiotherapy + nitroglycerin showed significantly better CNS-PFS and ORR...For previously treated BMs, pembrolizumab + chemotherapy, nivolumab + ipilimumab, and cemiplimab significantly prolonged OS than chemotherapy alone...The value of surgery should also be emphasized. The result should be further confirmed by RCTs.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    New P1 trial:  Cemiplimab/Peg-Interferon-? in Advanced CSCC (clinicaltrials.gov) -  Feb 15, 2023   
    P1,  N=21, Not yet recruiting, 
  • ||||||||||  Libtayo (cemiplimab) / Regeneron
    Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: longer follow-up results from the Phase 3 EMPOWER-Lung 3 trial (Auditorium 1) -  Feb 10, 2023 - Abstract #ELCC2023ELCC_282;    
    P3
    Table: 5O CI, confidence interval; DOR, duration of response; HR, hazard ratio; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; TEAEs, treatment-emergent adverse events. Conclusions At 28.4 months of follow-up, the EMPOWER-3 Lung trial continues to show an improvement in benefit of cemiplimab in combination with chemo, compared to chemo alone, for patients with advanced squamous and non-squamous NSCLC, regardless of PD-L1 expression level and without EGFR, ALK or ROS1 aberrations.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Enrollment closed, Trial completion date, Trial primary completion date:  Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer (clinicaltrials.gov) -  Feb 10, 2023   
    P1,  N=13, Active, not recruiting, 
    Conclusions At 28.4 months of follow-up, the EMPOWER-3 Lung trial continues to show an improvement in benefit of cemiplimab in combination with chemo, compared to chemo alone, for patients with advanced squamous and non-squamous NSCLC, regardless of PD-L1 expression level and without EGFR, ALK or ROS1 aberrations. Recruiting --> Active, not recruiting | Trial completion date: Sep 2024 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Dec 2024