Lenvima (lenvatinib) / Eisai, Merck (MSD) 
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 53 Diseases   490 Trials   490 Trials   8927 News 


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  • ||||||||||  Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
    Review, Journal:  Multimodal treatment of hepatocellular carcinoma (Pubmed Central) -  Feb 23, 2020   
    While the multityrosine kinase inhibitor sorafenib has been the only agent approved for patients with unresectable HCC for almost a decade, there are now additional systemic treatment options including the tyrosine kinase inhibitors (TKIs) lenvatinib, regorafenib, and cabozantinib as well as the VEGF-receptor inhibitor ramucirumab...Today, treatment of patients with HCC is more challenging than ever owing to the multiple therapeutic options available, demanding strict multidisciplinary cooperation in the treatment selection process. There is an urgent need for clinical studies in order to further optimize the therapy sequence and to identify efficacious mono- and combination therapies.
  • ||||||||||  Lenvima (lenvatinib) / Eisai, Merck (MSD), Nexavar (sorafenib) / Bayer, Amgen
    Journal, IO Biomarker:  Impact of Age-Related Genetic Differences on the Therapeutic Outcome of Papillary Thyroid Cancer. (Pubmed Central) -  Feb 23, 2020   
    Our findings clarify the age-dependent characteristics of pediatric PTC, giving insights into the relationship between young age and poor prognosis. Furthermore, it provides a basis for developing novel therapeutics tailored to the age at diagnosis.
  • ||||||||||  Lenvima (lenvatinib) / Eisai, Merck (MSD)
    Journal:  Body Composition and Leptin/Ghrelin Levels during Lenvatinib for Thyroid Cancer. (Pubmed Central) -  Feb 21, 2020   
    Nevertheless, oral nutritional supplements should be given as early as possible and athletic patients should be encouraged to maintain physical activity. In some circumstances, parenteral nutrition is required for the rehabilitation of these patients.
  • ||||||||||  Lenvima (lenvatinib) / Eisai, Merck (MSD)
    Clinical, Journal:  Post-Progression Treatment Eligibility of Unresectable Hepatocellular Carcinoma Patients Treated with Lenvatinib. (Pubmed Central) -  Feb 21, 2020   
    From March 2018 to June 2019, 156 u-HCC patients with Child-Pugh A were enrolled (median age: 71 years, Child-Pugh score 5:6 = 105:51, BCLC A:B:C = 8:56:92, modified albumin-bilirubin grade (mALBI) 1:2a:2b = 59:42:55, past history of sorafenib:regorafenib = 57:17)...Non-mALBI 1/2a at the start of LEN was a significant risk factor for decline to CPB during LEN treatment (HR 2.552, 95% CI: 1.577-4.129; p < 0.001). Introduction of TKI therapy including LEN for u-HCC patients with better hepatic function (mALBI 1/2a: ALBI score ≤-2.27), when possible, increases the chance of undergoing post-progression treatment, which can improve PPS.
  • ||||||||||  Enrollment open, Trial completion date, Trial primary completion date, PD(L)-1 Biomarker, Metastases:  Immune Checkpoint Therapy vs Target Therapy in Reducing Serum HBsAg Levels in Patients With HBsAg+ Advanced Stage HCC (clinicaltrials.gov) -  Feb 18, 2020   
    P2,  N=30, Recruiting, 
    In a subset analysis of responders who had received subsequent anticancer medication, use of first-line lenvatinib led to a slightly longer median OS; more research is needed on the benefits of using first-line lenvatinib compared with sorafenib. Not yet recruiting --> Recruiting | Trial completion date: Dec 2020 --> Mar 2022 | Trial primary completion date: Oct 2020 --> Dec 2021
  • ||||||||||  Enrollment change, Trial completion date, Trial primary completion date, PD(L)-1 Biomarker:  The Drug Rediscovery Protocol (DRUP Trial) (clinicaltrials.gov) -  Feb 17, 2020   
    P2,  N=950, Recruiting, 
    Patient education and prophylactic medications should be provided at treatment initiation to appropriately manage AEs. N=400 --> 950 | Trial completion date: Dec 2019 --> Dec 2022 | Trial primary completion date: Aug 2019 --> Aug 2022
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
    Journal:  New Systemic Treatments in Advanced Hepatocellular Carcinoma. (Pubmed Central) -  Feb 16, 2020   
    In addition, nivolumab as a second-line agent was approved by the US Food and Drug Administration in 2017 based on improved radiological response data...Although several first-line or second-line treatments have been shown to be effective for HCC, each of these trials was composed of its own specific populations and those with HCC recurrence post-LT were excluded. We have also summarized from a critical and clinical point of view the issues involved in the management of patients who are candidates for systemic treatment in this era of multiple drugs for the same indication.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
    Biomarker, Review, Journal, PD(L)-1 Biomarker, IO Biomarker:  Pharmacogenetics of the systemic treatment in advanced hepatocellular carcinoma. (Pubmed Central) -  Feb 15, 2020   
    Other molecules, such as the selective CDK4/6inhibitors (e.g., palbociclib, ribociclib), are in earlier stages of clinical development, and the c-MET inhibitor tivantinib did not show positive results in a phase III study...Particularly, a number of studies have focused on the role of genetic polymorphisms impacting the drug metabolic pathway and membrane translocation as well as the drug mechanism of action as predictive/prognostic markers of HCC treatment. The aim of this review is to summarize and critically discuss the pharmacogenetic literature evidences, with particular attention to sorafenib and regorafenib, which have been used longer than the others in HCC treatment.
  • ||||||||||  doxorubicin hydrochloride / Generic mfg.
    Review, Journal, PD(L)-1 Biomarker, IO Biomarker:  Novel treatments for anaplastic thyroid carcinoma. (Pubmed Central) -  Feb 15, 2020   
    The standard treatment of ATC includes surgical debulking, accelerated hyperfractionated external beam radiation therapy (EBRT), and chemotherapy, in particular with cisplatin or doxorubicin, achieving about 10 months of median survival...We report interesting results obtained with molecules targeting different pathways: angiogenesis (vandetanib, combretastatin, sorafenib, lenvatinib, sunitinib, CLM94, CLM3, etc.); EGFR (gefitinib, docetaxel); BRAF (dabrafenib/trametinib, vemurafenib); PPARγ agonists (rosiglitazone, pioglitazone, efatutazone); PD-1 and PD-L1 (pembrolizumab); TERT...Furthermore, to increase the therapeutic success and not to use ineffective or even harmful treatments, a real tailored therapy should be pursued, and this can be achieved thanks to the new available genomic analysis methods and to the possibility to test in vitro novel treatments directly in primary cells from each ATC patient. Exploring new treatment strategies is mandatory to improve the survival of these patients, guaranteeing a good quality of life.
  • ||||||||||  Emerging combinations in HCC () -  Feb 15, 2020 - Abstract #PLCECNT2020PLC_ECNT_28;    
    Cell-based therapies are also emerging in HCC with TCR-based approaches targeting AFP and CAR-T cells directed against glypican 3. Whilst the early-phase studies are yet to reported in full, there is a clear rational for combining these with checkpoint inhibition should they be prove to be tolerable as single agents.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
    Biomarker and response prediction in HCC and CCA () -  Feb 15, 2020 - Abstract #PLCECNT2020PLC_ECNT_27;    
    Regarding intrahepatic cholangiocarcinoma (iCCA), a recent positive trial in patients with iCCA enrichment with IDH1 mutations have shown significant outcome benefit. Similarly, a phase II study also pointed towards FGFR2 fusions as predictors of re- sponse to FGFR2 inhibitors, a concept that needs to be validated in the setting of phase III investigations.
  • ||||||||||  Lenvima (lenvatinib) / Eisai, Merck (MSD), Nexavar (sorafenib) / Bayer, Amgen
    Clinical, Journal:  Radioiodine therapy of advanced DTC: clinical considerations and multidisciplinary approach. (Pubmed Central) -  Feb 14, 2020   
    In recent years, new therapeutic agents with molecular targets have become available and two multi-kinase inhibitors, Sorafenib and Lenvatinib, have been licensed for iodine refractory DTC showing an advantage in terms of progression-free survival, although an impact on overall survival has not been proven yet and remarkable side-effects emerged. Management of advanced thyroid cancer can be challenging but a multidisciplinary approach can significantly improve outcomes for this patient population.
  • ||||||||||  Caprelsa (vandetanib) / Sanofi, Lenvima (lenvatinib) / Eisai, Merck (MSD), Nexavar (sorafenib) / Bayer, Amgen
    Clinical, Review, Journal:  Molecular Alterations in Thyroid Cancer: From Bench to Clinical Practice. (Pubmed Central) -  Feb 14, 2020   
    In this review, we will describe the genomic alterations and biological processes intertwined with thyroid cancer development, also providing a thorough overview of targeted drugs already tested or under investigation for these tumors. Furthermore, given the existing preclinical evidence, we will briefly discuss the potential role of immunotherapy as an additional therapeutic strategy for the treatment of thyroid cancer.
  • ||||||||||  Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
    Review, Journal:  Controversies in the management of hepatocellular carcinoma. (Pubmed Central) -  Feb 13, 2020   
    Expectations for immune checkpoint inhibitors are high, with the results of the ongoing phase III trials eagerly awaited. In this review we discuss some of the controversies in the management of HCC, focussing in particular on systemic therapy.
  • ||||||||||  Lenvima (lenvatinib) / Eisai, Merck (MSD)
    Enrollment change:  DEB-TACE Plus Lenvatinib or Sorafenib or PD-1 Inhibitor for Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) -  Feb 11, 2020   
    P3,  N=90, Not yet recruiting, 
    Thyroid dysfunction and appetite loss after the administration of LEN were independent factors associated with shorter PFS, so these AEs should be carefully managed after administering LEN. N=60 --> 90
  • ||||||||||  Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
    Primary Adrenal Insufficiency During Tyrosine Kinase Inhibitors Treatment in Advanced Thyroid Cancer Patients (ENDOExpo) -  Feb 7, 2020 - Abstract #ENDO2020ENDO_3425;    
    The appearance of fatigue, the typical symptom of PAI, could be multifactorial in these pts due also to the direct effect of TKIs treatment. Thus, in these cases is very difficult to recognize the cause of fatigue and to decide the appropriate treatment (cortisone acetate replacement therapy vs TKIs dose reduction).
  • ||||||||||  Thyrogen (thyrotropin alfa) / Sanofi, Lenvima (lenvatinib) / Eisai, Merck (MSD), Tafinlar (dabrafenib) / Novartis
    Complex Thyroid Cancer with Several Recurrences and Metastases (ENDOExpo) -  Feb 7, 2020 - Abstract #ENDO2020ENDO_2577;    
    Subsequent thyrogen stimulated whole-body scan in 2/2016 showed no areas of uptake.However, in 12/2016 he was found to have right supraclavicular lymph nodes positive for recurrence which was resected and given another 168 mCi I-131 and 33 treatments of XRT to R shoulder.A repeat PET in 7/2019 showed persistent hyper metabolic lesion in C7, multiple hyper metabolic nodules throughout the R lung, and a new 1.1 cm left Hilar lymph node suggesting disease progression...Loss of response to I-131, very low serum thyroglobulin levels despite known disease, and high PET avidity provide clinical evidence of dedifferentiation, confirmed with tissue sampling.If feasible targeted systemic therapy remains the best tolerated treatment option.While several studies demonstrate an increase in iodine avidity in approximately 50-60% of patients with dedifferentiated thyroid cancer that were treated with tyrosine kinase inhibitors (TKI), (cite alan Ho's 2013 NEJM article, and the 2015 debrafenib study Rothenberg SM et al, clin cancer res 2015 ), selumetanib remains unavailable for clinical use and dabrafenib may only be beneficial in cases with known BRAF V600E mutations...This patient demonstrated excellent response to I-131 therapy with lenvatinib pretreatment.A number of formal studies of various TKIs for thyroid cancer re-differentiation are currently underway. (cite Brown SR, Hall A, et al BMC cancer 2019; and also cite the CIII trial with cabozatanib) Conclusion This case represents the emerging paradigm for the ability of TKI therapy to redifferentiate advanced thyroid cancer and allow for re-treatment with I-131 targeted therapy.