Lenvima (lenvatinib) / Eisai, Merck (MSD) 
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  • ||||||||||  Lenvima (lenvatinib) / Eisai, Merck (MSD)
    Trial completion, Enrollment change:  Post-Marketing Surveillance of Lenvima in Korean Patients (clinicaltrials.gov) -  Oct 7, 2021   
    P=N/A,  N=132, Completed, 
    Active, not recruiting --> Completed | N=3000 --> 132
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD)
    Journal:  The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. (Pubmed Central) -  Oct 3, 2021   
    P2, P3
    Thus, lenvatinib plus pembrolizumab is anticipated to be an important potential new regimen for several solid cancers that currently have limited therapeutic options. Clinical Trial Registration: NCT03884101, NCT03713593, NCT03820986, NCT03776136, NCT03797326, NCT03829319, NCT03829332, NCT03976375, NCT04428151, NCT04199104, NCT03898180, NCT04246177 (ClinicalTrials.gov).
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD)
    KEYNOTE-495/KeyImPaCT: interim analysis of a randomized, biomarker-directed, phase 2 trial of pembrolizumab-based combination therapy for non–small cell lung cancer (NSCLC) () -  Oct 1, 2021 - Abstract #SITC2021SITC_1238;    
    P2
    View this table: View inline View popup Download powerpoint Abstract 457 Table 1 Confirmed ORR by Therapy and Biomarker Status Conclusions These data demonstrate the feasibility and clinical usefulness of prospective Tcell inf GEP and TMB assessment to study the clinical activity of three first-line pembrolizumab-based combination therapies in patients with advanced NSCLC. Although sample sizes were small, the Tcell inf GEP high TMB high subgroup demonstrated the best response among the biomarker subgroups for all three combination therapies; further validation is needed to determine additional signals and may be addressed as more mature data become available.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, cadonilimab (AK104) / Akesobio
    Cadonilimab, an anti-PD1/CTLA4 bi-specific antibody with Fc effector null backbone (Poster Hall) -  Oct 1, 2021 - Abstract #SITC2021SITC_350;    
    P1/2, P2
    Conclusions Cadonilimab, an IgG1 antibody with Fc-engineering, exhibits neither Fc effector functions including ADCC, ADCP, CDC, nor activating macrophage to secret IL-6 or IL-8. Possible tumor tissue preferential retention of Cadonilimab over conventional anti-PD-1 and anti-CTLA-4 antibodies noted above could potentially lead to better safety profile.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD)
    ENGOT-en11/GOG-3053/KEYNOTE-B21: phase 3 study of pembrolizumab or placebo + adjuvant chemotherapy ± radiotherapy for high-risk endometrial cancer () -  Oct 1, 2021 - Abstract #ESGO2021ESGO_532;    
    P3
    Introduction/Background* Pembrolizumab, an anti-PD-1 antibody, has demonstrated activity in patients with previously treated mismatch repair (MMR) deficient (dMMR; 57.1% objective response rate [ORR] as monotherapy and 63.6% ORR as combination therapy with lenvatinib) and MMR proficient (pMMR; 36.2% ORR as combination therapy with lenvatinib) endometrial cancer...Approximately 990 patients are randomized to receive pembrolizumab 200 mg or placebo every 3 weeks (Q3W) for 6 cycles plus chemotherapy (carboplatin area under the curve [AUC] 5/6 plus paclitaxel 175 mg/m 2 Q3W or carboplatin AUC 2/2.7 plus paclitaxel 60 mg/m 2 QW) in stage 1...Radiotherapy (external beam radiotherapy [EBRT] and/or brachytherapy) ± radiosensitizing cisplatin 50 mg/m 2 (days 1 and 29) may be administered after completion of chemotherapy...Enrolment began December 2020 and is ongoing at 221 sites in 28 countries. Result(s)* N/A Conclusion* N/A
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen, Nexavar (sorafenib) / Bayer, Amgen
    Journal:  Systemic targeted and immunotherapy for advanced hepatocellular carcinoma. (Pubmed Central) -  Oct 1, 2021   
    As will be presented, clinicians play a critical role in prompt identification and AR-directed management of patients with aEC; such management may potentially reduce treatment interruption(s) and/or lenvatinib dose reduction. Targeted agents and checkpoint inhibitors are the standard of therapy for patients who need systemic therapy for advanced HCC.
  • ||||||||||  Avastin (bevacizumab) / Roche, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen, Nexavar (sorafenib) / Bayer, Amgen
    Clinical, Review, Journal:  Second-Line Treatment Options for Hepatocellular Carcinoma: Current Landscape and Future Direction. (Pubmed Central) -  Sep 30, 2021   
    Most recently, the combination of atezolizumab plus bevacizumab has resulted in the longest overall survival yet known in hepatocellular carcinoma, therefore changing the preferred first-line treatment from the previous options of sorafenib and lenvatinib. The aim of this review is to summarize the available clinical data for the current second-line systemic treatment options and the future perspectives in the treatment landscape of hepatocellular carcinoma.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen, Nexavar (sorafenib) / Bayer, Amgen
    Review, Journal, PD(L)-1 Biomarker, IO biomarker:  How Immunotherapy Has Changed the Continuum of Care in Hepatocellular Carcinoma. (Pubmed Central) -  Sep 29, 2021   
    Future research should include the evaluation of molecular biomarkers that can help patient selection and provide new insight on potential combined approaches. In this review, we provide an overview of the clinical evidence of the use of immune checkpoint inhibitors in HCC, and discuss how immunotherapy has been implemented into the continuum of HCC care.
  • ||||||||||  lenvatinib / Generic mfg.
    Journal:  Lenvatinib: an investigational agent for the treatment of differentiated thyroid cancer. (Pubmed Central) -  Sep 29, 2021   
    According to the SELECT trial, the treatment should be initiated with a dosage of 24 mg/day, subsequently decreasing it in relation to the side effects. The decision making process in patients with aggressive RAI-refractory DTC should be personalized and the potential toxicity should be properly managed.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
    Journal, HEOR:  Cost-Effectiveness of Frontline Treatment for Advanced Renal Cell Carcinoma in the Era of Immunotherapies. (Pubmed Central) -  Sep 28, 2021   
    Materials and A microsimulation model was created to project the healthcare costs and outcomes of six strategies (lenvatinib-plus-pembrolizumab, nivolumab-plus-cabozantinib, nivolumab-plus-ipilimumab, pembrolizumab-plus-axitinib, avelumab-plus-axitinib, and sunitinib monotherapy) for patients with aRCC...The cost of sunitinib drove the model most influentially. For aRCC, the pembrolizumab-plus-axitinib strategy is likely to be the most cost-effective alternative at the willingness-to-pay threshold of $100,000.
  • ||||||||||  lenvatinib / Generic mfg.
    Journal, Checkpoint inhibition, IO biomarker:  Multi-Omics Analysis of the Anti-tumor Synergistic Mechanism and Potential Application of Immune Checkpoint Blockade Combined With Lenvatinib. (Pubmed Central) -  Sep 28, 2021   
    This study verified the potential synergistic mechanisms of ICB combined with lenvatinib at transcriptomics, genomics, protein, and cellular levels and recognized nine tumor types had ≥ 2 positive treatment-related molecular characteristics, which might benefit particularly from this combined strategy. The findings would help to provide clinical insights and theoretical basis for optimizing of targeted therapy-immunotherapy combinations, and for guiding individualized precision-medicine approaches for cancer treatment.
  • ||||||||||  Lenvima (lenvatinib) / Eisai, Merck (MSD)
    Trial completion:  Pharmacokinetic Study of E7080/Lenvatinib in Chinese Subjects With Solid Tumor (clinicaltrials.gov) -  Sep 28, 2021   
    P1,  N=12, Completed, 
    The findings would help to provide clinical insights and theoretical basis for optimizing of targeted therapy-immunotherapy combinations, and for guiding individualized precision-medicine approaches for cancer treatment. Active, not recruiting --> Completed