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


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  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Prognostic Utility of Peripheral Myeloid Cells for Clinical Outcomes in Patients with NSCLC Treated with Cemiplimab (Exhibit Hall) -  Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1428;    
    P3
    Conclusions : This analysis shows that peripheral blood cell count parameters, including putative immunosuppressive neutrophils and monocytes as well as protective lymphocytes and eosinophils, may predict outcomes with anti-PD-1 therapy in patients with advanced NSCLC. While the variables in the nomogram were statistically significant and enhanced the ability to discern difference over the baseline model, overall discrimination was moderate, indicating that more data are needed to better predict clinical outcomes in this setting.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
    Phase 2 Peri-Operative Study of Fianlimab+Cemiplimab+Chemotherapy vs Cemiplimab+Chemotherapy in Resectable Early-Stage NSCLC (Exhibit Hall) -  Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1369;    
    P1, P2, P2
    The key secondary endpoints are event-free survival by investigator assessment, major pathological response by BIPR, tumor response by investigator assessment, safety, pharmacokinetics, immunogenicity, and patient-reported outcomes. In addition, there are two Phase 2/3 studies (NCT05785767 and NCT05800015) exploring fianlimab + cemiplimab
  • ||||||||||  fianlimab (REGN3767) / Regeneron
    Fianlimab-Based Combination Therapies in Patients with Advanced Non-Small Cell Lung Cancer: Trials in Progress Updates (Exhibit Hall) -  Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1223;    
    P1, P2, P2
    Secondary endpoints for both studies include tolerability, safety, ORR per investigator assessment, disease control rate, time to tumor response, duration of response, progression-free survival, OS (Phase 2), patient-reported outcomes, pharmacokinetics, and immunogenicity. Both studies are currently open for enrollment, along with a third Phase 2 study in which fianlimab + cemiplimab + chemotherapy versus cemiplimab + chemotherapy will be evaluated as perioperative therapy in patients with stage II/III NSCLC (NCT06161441).
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD), Tecentriq (atezolizumab) / Roche
    Review, Journal, PD(L)-1 Biomarker, IO biomarker:  Evolving Precision First-Line Systemic Treatment for Patients with Unresectable Non-Small Cell Lung Cancer. (Pubmed Central) -  Jul 13, 2024   
    Lastly, for the remaining ~50% of patients who are fit and whose tumors have no or low PD-L1 expression (TPS of 0-49%) and no sensitizing EGFR/ALK aberrations, platinum-containing chemotherapy with the addition of a PD-1/L1 inhibitor alone or in combination of a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor improves PFS and OS compared to chemotherapy alone. The objectives of this review are to summarize the current data and perspectives on first-line systemic treatment in patients with unresectable NSCLC and propose a practical algorithm for implementing precision biomarker testing at diagnosis.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Journal, PD(L)-1 Biomarker, IO biomarker:  Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer with PD-L1 (Pubmed Central) -  Jul 6, 2024   
    P3
    Recruiting --> Active, not recruiting In this subgroup analysis from EMPOWER-Lung 3 part 2, cemiplimab plus chemotherapy demonstrated clinical benefit over chemotherapy alone in patients with advanced squamous or non-squamous NSCLC with PD-L1
  • ||||||||||  Mekinist (trametinib) / Novartis, BeiGene, Libtayo (cemiplimab-rwlc) / Regeneron, Tafinlar (dabrafenib) / Novartis
    Trial completion date, Trial primary completion date, IO biomarker:  Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer (clinicaltrials.gov) -  Jul 3, 2024   
    P2,  N=15, Recruiting, 
    No abstract available Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Trial completion date, Trial primary completion date:  Cemiplimab for the Treatment of Untreated Brain Metastases From PD-L1 >= 50% Non-Small Cell Lung Cancer (clinicaltrials.gov) -  Jun 27, 2024   
    P2,  N=34, Recruiting, 
    Moreover, in our population, the clinical benefits were also related to a longer progression-free survival, without any safety alert reported. Trial completion date: Jan 2028 --> Oct 2029 | Trial primary completion date: Jan 2028 --> Oct 2029
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Biomarker, Trial completion date, Trial primary completion date:  BIOSELECT: BIOmarker-guided Study to Evaluate the Efficacy and Safety of cemipLimab for advancEd Cutaneous T-cell Lymphoma (clinicaltrials.gov) -  Jun 14, 2024   
    P1/2,  N=16, Not yet recruiting, 
    Careful consideration should be given to the possibility of an increased risk of diabetes and ketoacidosis after using ICIs, and careful monitoring for diabetes and ketoacidosis is recommended. Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Feb 2024 --> Feb 2025
  • ||||||||||  BHV-1510 / Biohaven
    Enrollment open, Monotherapy:  A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors (clinicaltrials.gov) -  Jun 13, 2024   
    P1/2,  N=170, Recruiting, 
    Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Feb 2024 --> Feb 2025 Not yet recruiting --> Recruiting
  • ||||||||||  Trial completion date, Trial primary completion date, Checkpoint inhibition, IO biomarker:  Exercise to Boost Response to Checkpoint Blockade Immunotherapy (clinicaltrials.gov) -  May 22, 2024   
    P1,  N=32, Recruiting, 
    The incorporation of these guidelines into clinical practice is expected to enhance patient care and address the evolving landscape of CSCC management. Trial completion date: May 2024 --> Sep 2024 | Trial primary completion date: May 2024 --> Sep 2024
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / BMS
    Review, Journal, Metastases:  Metastatic patterns and treatment options for head and neck cutaneous squamous cell carcinoma (Review). (Pubmed Central) -  May 17, 2024   
    Notably, there is an urgent need to identify patients who may benefit from local or systemic cancer treatments. The treatment of lymph node metastasis presents a therapeutic challenge and requires comprehensive management.