Lenvatinib

(Lenvima®)

Lenvima®

Drug updated on 10/31/2024

Dosage FormCapsule (oral; 4 mg, 10 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC)
  • Indicated in combination with pembrolizumab, for the first line treatment of adult patients with advanced renal cell carcinoma (RCC)
  • Indicated in combination with everolimus, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy
  • Indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)
  • Indicated in combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma (EC) that is mismatch repair proficient (pMMR), as determined by an FDA-approved test, or not microsatellite instability-high (MSI-H), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Latest News

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Summary
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  • This summary is based on the review of 62 systematic review(s)/meta-analysis(es). [1-62]
  • In hepatocellular carcinoma (HCC), HAIC-FO (Hepatic artery infusion chemotherapy with oxaliplatin plus fluorouracil) demonstrated notable effectiveness in improving overall survival (OS), particularly in patients with macrovascular invasion (MVI) and extrahepatic spread (EHS), showing the highest effectiveness in this subgroup (SUCRA (Surface Under the Cumulative Ranking Curve) = 0.99). HAIC-FO also achieved superior progression-free survival (PFS) and objective response rate (ORR) compared to anti-VEGF-TKI (vascular endothelial growth factor tyrosine kinase inhibitors) and immune checkpoint inhibitor monotherapies.
  • For renal cell carcinoma (RCC), lenvatinib combined with pembrolizumab presented enhanced OS and PFS benefits, especially for intermediate- and poor-risk patients, with robust evidence from the CLEAR trial showing superiority over sunitinib. The combination was also linked to the highest likelihood of improved ORR compared to other treatments, including nivolumab plus cabozantinib.
  • In endometrial cancer, lenvatinib plus pembrolizumab yielded a median OS ranging from 17.2 months to an undefined upper limit, with a median PFS of up to 258 days and a pooled ORR of 32.7%. Enhanced response rates were noted in the dMMR group compared to the pMMR group, indicating potential subgroup benefits.
  • For thyroid cancer, lenvatinib demonstrated significant OS and PFS improvements in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC) compared to placebo, underscoring its efficacy in this specific cancer type.
  • In hepatocellular carcinoma (HCC), lenvatinib was frequently associated with hypertension and proteinuria but had a lower incidence of hand-foot-skin reactions compared to sorafenib.
  • In renal cell carcinoma (RCC) and endometrial cancer, lenvatinib combined with pembrolizumab showed a high incidence of adverse events, with 80.2% of patients experiencing grade ≥3 events. For endometrial cancer specifically, the pooled proportions of any-grade and grade ≥3 adverse events were 95.8% and 80.2%, respectively.
  • In adenoid cystic carcinoma (ACC), lenvatinib treatment led to notable rates of grade ≥3 adverse events, particularly hypertension and proteinuria.
  • For medullary thyroid cancer, lenvatinib and other tyrosine kinase inhibitors (TKIs) commonly led to grade ≥3 adverse events, including hypertension, decreased appetite, rash, and lymphopenia, highlighting the frequent occurrence of serious side effects across different cancer types treated with lenvatinib.
  • In hepatocellular carcinoma (HCC), tremelimumab combined with durvalumab showed the greatest efficacy in Asian populations (SUCRA = 0.88).
  • For renal cell carcinoma (RCC), lenvatinib combined with pembrolizumab showed numerical overall survival improvement in intermediate- to poor-risk patients. In endometrial cancer, patients with deficient mismatch repair (dMMR) exhibited higher objective response and disease control rates compared to those with proficient mismatch repair (pMMR).

Product Monograph / Prescribing Information

Document TitleYearSource
Lenvima (lenvatinib) Prescribing Information.2024Eisai Inc., Nutley, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of first-line treatments for advanced hepatocellular carcinoma patients: a systematic review and network meta-analysis2024Frontiers in Immunology
Phase I-IV Drug Trials on Hepatocellular Carcinoma in Asian Populations: A Systematic Review of Ten Years of Studies2024International Journal of Molecular Sciences
Lenvatinib plus pembrolizumab for untreated advanced renal cell carcinoma: a systematic review and cost-effectiveness analysis2024Health Technology Assessment
Efficacy and safety of lenvatinib plus pembrolizumab in patients with advanced and recurrent endometrial cancer: a systematic review and meta-analysis2024Frontiers in Immunology
Systemic conversion therapies for initially unresectable hepatocellular carcinoma: a systematic review and meta-analysis2024BMC Cancer
The efficacy and safety of antiangiogenesis tyrosine kinase inhibitors in patients with advanced anaplastic thyroid cancer: A meta-analysis of prospective studies2024Medicine
The Long Journey towards Personalized Targeted Therapy in Poorly Differentiated Thyroid Carcinoma (PDTC): A Case Report and Systematic Review2024Journal of Personalized Medicine
Vascular Endothelial Growth Factor Receptor Inhibitors for Recurrent or Metastatic Adenoid Cystic Carcinoma: A Systematic Review and Meta-Analysis2024JAMA Otolaryngology
The efficacy and safety of the novel combination lenvatinib and pembrolizumab in endometrial cancer: A systematic review and single-arm meta-analysis2024Heliyon
First-line immunotherapy of metastatic renal cell carcinoma: an updated network meta-analysis including triplet therapy2024BJU International
Efficacy and safety of tyrosine kinase inhibitors for advanced metastatic thyroid cancer: A systematic review and network meta-analysis of randomized controlled trials2024Medicine
Efficacy and toxicity of immune checkpoint inhibitors combination therapy for advanced renal cell carcinoma: a systematic review and network meta-analysis2024Frontiers in Immunology
Network meta-analysis of second line and beyond treatment options in metastatic clear cell renal cell carcinoma2024Urologic Oncology
Efficacy of Atezolizumab Plus Bevacizumab Versus Lenvatinib in Patients with Unresectable Hepatocellular Carcinoma: a Meta-analysis2024Journal of Gastrointestinal Cancer
Major adverse cardiovascular events of vascular endothelial growth factor tyrosine kinase inhibitors among patients with different malignancy: A systemic review and network meta-analysis2024Journal of The Chinese Medical Association
Efficacy and safety comparison between Lenvatinib and Sorafenib in hepatocellular carcinoma treatment: a systematic review and meta-analysis of real-world study2024European Journal Of Gastroenterology & Hepatology
Critical Appraisal of Guideline Recommendations on Systemic Therapies for Advanced Hepatocellular Carcinoma: A Review2024JAMA Oncology
Immunotherapy and Targeted Therapies Efficacy in Thymic Epithelial Tumors: A Systematic Review2023Biomedicines
Comparative safety of tyrosine kinase inhibitors in the treatment of metastatic renal cell carcinoma: a systematic review and network meta-analysis2023Frontiers in Pharmacology
Efficacy and safety of atezolizumab plus bevacizumab versus lenvatinib for unresectable hepatocellular carcinoma: a systematic review and meta-analysis2023Journal of Cancer Research and Clinical Oncology
Pembrolizumab plus lenvatinib in advanced endometrial cancer: case report and systematic review of lung toxicity2023Frontiers in Oncology
Efficacy of transarterial therapy combined with first-line tyrosine kinase inhibitors for unresectable hepatocellular carcinoma: a network meta-analysis2023World Journal of Surgical Oncology
Safety and Efficacy of TACE + Lenvatinib in Treating Advanced Hepatocellular Carcinoma: A Systematic Review and Meta- analysis2023Journal of Gastrointestinal And Liver Diseases
Prevalence and Effect of Low Skeletal Muscle Mass among Hepatocellular Carcinoma Patients Undergoing Systemic Therapy: A Systematic Review and Meta-Analysis2023Cancers
First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis2023The Cochrane Database of Systematic Reviews
Comparing efficacy and safety of first-line treatment of metastatic renal cell carcinoma: A Bayesian network meta-regression analysis2023Frontiers in Oncology
Transarterial chemoembolization combined with lenvatinib versus transarterial chemoembolization combined with sorafenib for unresectable hepatocellular carcinoma: A systematic review and meta-analysis2023Frontiers in Oncology
A meta-analysis of the efficacy and toxicity of tyrosine kinase inhibitors in treating patients with different types of thyroid cancer: how to choose drugs appropriately?2023Current Opinion in Oncology
Everolimus and temsirolimus are not the same second-line in metastatic renal cell carcinoma: a systematic review and meta-analysis2023Cost Effectiveness and Resource Allocation
Efficacy of Transarterial Chemoembolization Combined with Tyrosine Kinase Inhibitors for Hepatocellular Carcinoma Patients with Portal Vein Tumor Thrombus: A Systematic Review and Meta-Analysis2023Current Oncology
First-line therapy for elderly patients with advanced renal cell carcinoma in the immuno-oncology era: a network meta-analysis2023Cancer Immunology
Optimizing targeted drug selection in combination therapy for patients with advanced or metastatic renal cell carcinoma: A systematic review and network meta-analysis of safety2023Cancer Medicine
Efficacy and safety of lenvatinib versus sorafenib in first-line treatment of advanced hepatocellular carcinoma: A meta-analysis2022Frontiers In Oncology
Lenvatinib as First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis2022Cancers
Safety of Anti-Angiogenic Drugs in Pediatric Patients with Solid Tumors: A Systematic Review and Meta-Analysis2022Cancers
IO-IO vs IO-TKI efficacy in metastatic kidney cancer patients: A structured systematic review over time2022Seminars in Oncology
Efficacy and safety of targeted therapeutics for patients with radioiodine-refractory differentiated thyroid cancer: Systematic review and network meta-analysis2022Frontiers in Pharmacology
Comparative efficacy of novel combination strategies for unresectable hepatocellular carcinoma: A network metanalysis of phase III trials2022European Journal of Cancer
Evolving landscape of first-line combination therapy in advanced renal cancer: a systematic review2022Therapeutic Advances in Medical Oncology
Prevalence and role of low skeletal muscle mass (LSMM) in hepatocellular carcinoma. A systematic review and meta-analysis2022Clinical Nutrition ESPEN
Incidence and risk of hypertension with lenvatinib in treatment of solid tumors: An updated systematic review and meta-analysis2022Journal of Clinical Hypertension
How Immunotherapy Modified the Therapeutic Scenario of Endometrial Cancer: A Systematic Review2022Frontiers in Oncology
Cost-Effectiveness Analysis of Five Systemic Treatments for Unresectable Hepatocellular Carcinoma in China: An Economic Evaluation Based on Network Meta-Analysis2022Frontiers in Public Health
Efficacy and Safety of First-line Systemic Therapy for Metastatic Renal Cell Carcinoma: A Systematic Review and Network Meta-analysis2022European Urology Open Science
Angiogenesis Inhibitors for Head and Neck Squamous Cell Carcinoma Treatment: Is There Still Hope?2021Frontiers in Oncology
Selection of first-line systemic therapies for advanced hepatocellular carcinoma: A network meta-analysis of randomized controlled trials2021World Journal of Gastroenterology
Clinical efficacy of lenvatinib for the treatment of radioiodine-refractory thyroid carcinoma: A systematic review and meta-analysis of clinical trials2021Clinical Endocrinology
Comparison of Efficacy of Systemic Therapies in Advanced Hepatocellular Carcinoma: Updated Systematic Review and Frequentist Network Meta-Analysis of Randomized Controlled Trials2021Journal of Hepatocellular Carcinoma
First-line Immunotherapy-based Combinations for Metastatic Renal Cell Carcinoma: A Systematic Review and Network Meta-analysis2021European Urology Oncology
Comparative evaluation of cardiovascular risks among nine FDA-approved VEGFR-TKIs in patients with solid tumors: a Bayesian network analysis of randomized controlled trials2021Journal of Cancer Research and Clinical Oncology
Safety and efficacy of pembrolizumab plus lenvatinib versus pembrolizumab and lenvatinib monotherapies in cancers: A systematic review2021International Immunopharmacology
Prognostic value of skeletal muscle mass during tyrosine kinase inhibitor (TKI) therapy in cancer patients: a systematic review and meta-analysis2021Internal and Emergency Medicine
A systematic literature review and network meta-analysis of first-line treatments for unresectable hepatocellular carcinoma based on data from randomized controlled trials2021Expert Review of Anticancer Therapy
Optimizing Survival and the Changing Landscape of Targeted Therapy for Intermediate and Advanced Hepatocellular Carcinoma: A Systematic Review2021Journal Of The National Cancer Institute
Systemic Therapy and Sequencing Options in Advanced Hepatocellular Carcinoma: A Systematic Review and Network Meta-analysis2020JAMA Oncology
Selective internal radiation therapies for unresectable early-, intermediate- or advanced-stage hepatocellular carcinoma: systematic review, network meta-analysis and economic evaluation2020Health Technology Assessment
Comparative efficacy and safety of tyrosine kinase inhibitors for thyroid cancer: a systematic review and meta-analysis2020Endocrine Journal
Targeted and immune therapies among patients with metastatic renal carcinoma undergoing hemodialysis: A systemic review2020Seminars in Oncology
Incidence and risk of proteinuria associated with newly approved vascular endothelial growth factor receptor tyrosine kinase inhibitors in cancer patients: an up-to-date meta-analysis of randomized controlled trials2020Expert Review of Clinical Pharmacology
Lenvatinib and sorafenib for differentiated thyroid cancer after radioactive iodine: a systematic review and economic evaluation2020Health Technology Assessment
Multikinase Inhibitor Treatment in Thyroid Cancer2019International Journal of Molecular Sciences
A systematic review of lenvatinib and sorafenib for treating progressive, locally advanced or metastatic, differentiated thyroid cancer after treatment with radioactive iodine2019BMC Cancer

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