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    DRUG:

    Lenvima (lenvatinib)

    i
    Other names: E7080, E-7080, E 7080, ER 20349200, ER-203492-00, MK-7902, ER20349200, ER-20349200, MK7902, MK 7902
    Company:
    Eisai, Knight Therap, Merck (MSD)
    Drug class:
    Multi-tyrosine kinase inhibitor
    Related drugs:
    1d
    ACTION-I: TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Sun Yat-sen University
    New P2 trial
    |
    Yervoy (ipilimumab) • Tyvyt (sintilimab) • Lenvima (lenvatinib) • Tabosun (ipilimumab N01 injection)
    5d
    Impact of BRAF, TERT, and novel mutations on the efficacy of lenvatinib for advanced papillary thyroid cancer: A national genomic database analysis. (PubMed, NPJ Precis Oncol)
    Conclusions Lenvatinib showed substantial efficacy in BRAF-mutated PTC, while TERT mutations did not predict poor outcomes. The identification of five genes associated with early treatment failure highlights the potential for genomic biomarkers to guide personalized therapy.
    Journal
    |
    BRAF (B-raf proto-oncogene) • TERT (Telomerase Reverse Transcriptase) • mTOR (Mechanistic target of rapamycin kinase) • KMT2A (Lysine Methyltransferase 2A) • CREBBP (CREB binding protein) • RICTOR (RPTOR Independent Companion Of MTOR Complex 2) • MUTYH (MutY homolog)
    |
    BRAF mutation • MLL mutation
    |
    Lenvima (lenvatinib)
    5d
    Comprehensive multi-platform tyrosine kinase profiling reveals novel actionable FGFR aberrations across sarcomas affecting the young. (PubMed, Mol Cancer Ther)
    We demonstrate marked tumor growth inhibition in all FP-RMS PDXs treated with single agent FGF401 (FGFR4-specific inhibitor) and single agent lenvatinib (multi-kinase FGFR-inhibitor), and report a clinical response to lenvatinib in a relapsed metastatic FP-RMS patient. Altogether, we identified new sarcoma patients who may benefit from FGFR-inhibitors, most notably FP-rhabdomyosarcoma via FGFR4/FGF8 co-expression.
    Journal
    |
    FGFR1 (Fibroblast growth factor receptor 1) • FGFR (Fibroblast Growth Factor Receptor) • FGFR4 (Fibroblast growth factor receptor 4) • FOXO1 (Forkhead box O1) • FGF8 (Fibroblast Growth Factor 8) • PAX3 (Paired Box 3)
    |
    Lenvima (lenvatinib) • roblitinib (FGF401)
    5d
    A Multicenter Clinical Study of Combined Therapy for Unresectable Hepatocellular Carcinoma (clinicaltrials.gov)
    P1/2, N=33, Recruiting, West China Hospital
    New P1/2 trial
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Lenvima (lenvatinib)
    5d
    Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) (clinicaltrials.gov)
    P3, N=450, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Opdivo (nivolumab) • Ibrance (palbociclib) • everolimus • Lenvima (lenvatinib) • Cabometyx (cabozantinib tablet) • Welireg (belzutifan)
    5d
    CONV3RSION: Conversion Therapy With FOLFOX-HAIC Plus Lenvatinib And Tislelizumab For Hepatocellular Carcinoma With Vp3 Portal Vein Tumor Thrombus (clinicaltrials.gov)
    P2, N=38, Not yet recruiting, First Hospital of China Medical University
    New P2 trial
    |
    5-fluorouracil • Lenvima (lenvatinib) • Tevimbra (tislelizumab-jsgr) • oxaliplatin • leucovorin calcium
    6d
    Lenvatinib and Everolimus in Treating Patients With Advanced, Unresectable Carcinoid Tumors (clinicaltrials.gov)
    P2, N=36, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Mar 2026 --> Mar 2028 | Trial primary completion date: Mar 2026 --> Mar 2028
    Trial completion date • Trial primary completion date
    |
    everolimus • Lenvima (lenvatinib)
    6d
    Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98) (clinicaltrials.gov)
    P1/2, N=110, Recruiting, Merck Sharp & Dohme LLC | Trial primary completion date: May 2026 --> Dec 2029
    Trial primary completion date
    |
    Lenvima (lenvatinib) • MK-4830 • favezelimab/pembrolizumab (MK-4280A) • quavonlimab/pembrolizumab (MK-1308A) • raludotatug deruxtecan (DS-6000)
    7d
    KEYNOTE-B59: GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=317, Recruiting, GI Innovation, Inc. | Trial completion date: Dec 2026 --> Jun 2028 | Trial primary completion date: Oct 2026 --> Jun 2028
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • efdelikofusp alfa (GI-101)
    7d
    Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors (clinicaltrials.gov)
    P2, N=29, Recruiting, University of California, San Francisco | Trial completion date: Oct 2027 --> Mar 2028 | Trial primary completion date: Jul 2027 --> Jan 2028
    Trial completion date • Trial primary completion date
    |
    SSTR (Somatostatin Receptor)
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib)
    8d
    Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) (clinicaltrials.gov)
    P3, N=3500, Recruiting, Merck Sharp & Dohme LLC | N=1343 --> 3500
    Enrollment change
    |
    Lynparza (olaparib) • Lenvima (lenvatinib) • favezelimab/pembrolizumab (MK-4280A)
    8d
    A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence (clinicaltrials.gov)
    P3, N=198, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P3 trial
    |
    Lenvima (lenvatinib) • Tevimbra (tislelizumab-jsgr)