Therapy Detail

Therapy Name Lenvatinib
Therapy Description

Lenvima (lenvatinib) inhibits VEGFR, FGFR, PDGFR, KIT, and RET, and suppresses cell proliferation and angiogenesis (PMID: 21781317, PMID: 25295214, PMID: 17943726). Lenvima (lenvatinib) is FDA approved for use in patients with radioactive iodine-refractory differentiated thyroid cancer, unresectable hepatocellular carcinoma, and in combination with Afinitor (everolimus) for renal cell carcinoma (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Lenvatinib Lenvima E7080 FGFR Inhibitor (Pan) 17 KIT Inhibitor 48 PDGFR Inhibitor (Pan) 27 RET Inhibitor 36 VEGFR Inhibitor (Pan) 29 Lenvima (lenvatinib) inhibits VEGFR, FGFR, PDGFR, KIT, and RET, and suppresses cell proliferation and angiogenesis (PMID: 21781317, PMID: 25295214, PMID: 17943726). Lenvima (lenvatinib) is FDA approved for use in patients with radioactive iodine-refractory differentiated thyroid cancer, unresectable hepatocellular carcinoma, and in combination with Afinitor (everolimus) for renal cell carcinoma (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRAF mut NRAS wild-type melanoma sensitive Lenvatinib Phase I Actionable In a Phase I clinical trial, Lenvima (lenvatinib) treatment resulted in stable disease in 100% (5/5) of melanoma patients harboring BRAF mutations and wild-type NRAS (PMID: 26169970). 26169970
Unknown unknown melanoma not applicable Lenvatinib Phase I Actionable In a Phase I trial, Lenvima (lenvatinib) was demonstrated to be well tolerated and displayed anti-tumor activity in patients with melanoma and renal cell carcinoma (PMID: 22516948). 22516948
Unknown unknown papillary thyroid carcinoma not applicable Lenvatinib Clinical Study Actionable In a clinical study, Lenvima (lenvatinib) treatment resulted in prolonged response in a papillary thyroid carcinoma patient whose disease progressed despite 3 prior therapies including Nexavar (sorafenib), Sutent (sunitinib), and Votrient (pazopanib) (PMID: 29167691). 29167691
FGFR2 W290C Advanced Solid Tumor sensitive Lenvatinib Preclinical - Cell culture Actionable In a preclinical study, Lenvima (lenvatinib) inhibited growth of transformed cells expressing FGFR2 W290C in culture (PMID: 23786770). 23786770
Unknown unknown colon cancer not applicable Lenvatinib Preclinical Actionable In a preclinical study, Lenvima (lenvatinib) induced apoptosis and inhibited proliferation of colorectal cancer cells in culture (PMID: 24255582). 24255582
KDR R1032Q colorectal cancer sensitive Lenvatinib Preclinical - Cell culture Actionable In a preclinical study, expression of KDR (VEGFR2) R1032Q in a colorectal cancer cell line resulted in increased sensitivity to Lenvima (lenvatinib), leading to increased growth inhibition in culture (PMID: 29588308). 29588308
FGFR1 over exp thyroid cancer sensitive Lenvatinib Preclinical Actionable In a preclinical study, Lenvima (lenvatinib) inhibited FGFR1 phosphorylation and signaling in thyroid cancer cells overexpressing FGFR1 (PMID: 25295214). 25295214
RET C634W thyroid cancer sensitive Lenvatinib Preclinical Actionable In a preclinical study, Lenvima (lenvatinib) inhibited RET phosphorylation and signaling in thyroid cancer cells expressing RET C634W (PMID: 25295214). 25295214
Unknown unknown sarcoma not applicable Lenvatinib Phase I Actionable In a Phase I trial, Lenvima (lenvatinib) demonstrated safety and anti-tumor activity in patients with advanced solid tumors, including partial responses in patients with soft-tissue sarcoma (PMID: 22516948). 22516948
BRAF wild-type NRAS mutant melanoma sensitive Lenvatinib Phase I Actionable In a Phase I clinical trial, Lenvima (lenvatinib) treatment resulted in stable disease in 83% (5/6) of melanoma patients harboring NRAS mutations and wild-type BRAF (PMID: 26169970). 26169970
Unknown unknown non-small cell lung carcinoma not applicable Lenvatinib Phase I Actionable In a Phase I clinical trial, Lenvima (lenvatinib) demonstrated anti-tumor activity in patients with several advanced solid tumor types, including patients with non-small cell lung cancer (PMID: 26169970). 26169970
FGFR2 K660E Advanced Solid Tumor sensitive Lenvatinib Preclinical - Cell culture Actionable In a preclinical study, Lenvima (lenvatinib) inhibited growth of transformed cells expressing FGFR2 K660E in culture (PMID: 23786770). 23786770
Unknown unknown renal cell carcinoma not applicable Lenvatinib Phase I Actionable In a Phase I trial, Lenvima (lenvatinib) was demonstrated to be well tolerated and displayed anti-tumor activity in patients with melanoma and renal cell carcinoma (PMID: 22516948). 22516948
Unknown unknown thyroid cancer not applicable Lenvatinib FDA approved Actionable In a Phase III trial that supported FDA approval, treatment with Lenvima (lenvatinib) improved progression free survival and response rates in patients with radioiodine-refractory thyroid cancer (PMID: 25671254). detail... 25671254
Unknown unknown thyroid cancer not applicable Lenvatinib Phase II Actionable In a Phase II clinical trial, Lenvima (lenvatinib) demonstrated partial response in 36% (21/59) of patients, partial response or stable disease in 80% (47/59), and median progression free survival of 9 months in patients with advanced medullary thyroid cancer (PMID: 26311725). 26311725
Unknown unknown thyroid medullary carcinoma not applicable Lenvatinib Phase II Actionable In a Phase II trial, advanced medullary thyroid cancer patients experienced an objective response rate of 36% (21/59, all partial responses) and median progression free survival was 9 months when treated with Lenvima (lenvatinib) (PMID: 26311725). 26311725
BRAF mut NRAS mut melanoma sensitive Lenvatinib Phase I Actionable In a Phase I clinical trial, Lenvima (lenvatinib) treatment resulted in stable disease in 50% (1/2) of melanoma patients harboring both BRAF and NRAS mutations (PMID: 26169970). 26169970
Unknown unknown hepatocellular carcinoma not applicable Lenvatinib Phase I Actionable In a Phase I trial, Lenvima (lenvatinib) resulted in safety and preliminary efficacy in patients with hepatocellular carcinoma, demonstrating a partial response in 15% (3/20) of patients and tumor regression in 70% (14/20) (PMID: 26500236). 26500236
Unknown unknown hepatocellular carcinoma not applicable Lenvatinib Phase II Actionable In a Phase II trial, Lenvima (lenvatinib) treatment resulted in partial response in 37% (17/46) and stable disease in 41% (19/46) of patients with advanced hepatocellular carcinoma, and a median overall survival of 18.7 months (PMID: 27704266). 27704266
Unknown unknown hepatocellular carcinoma not applicable Lenvatinib FDA approved Actionable In a Phase III trial (REFLECT) that supported FDA approval, Lenvima (lenvatinib) demonstrated activity comparable to Nexavar (sorafenib), resulted in a median survival time of 13.6 months in patients with unresectable hepatocellular carcinoma (PMID: 29433850; NCT01761266). 29433850
FGFR2 K660N Advanced Solid Tumor sensitive Lenvatinib Preclinical - Cell culture Actionable In a preclinical study, Lenvima (lenvatinib) inhibited growth of transformed cells expressing FGFR2 K660N in culture (PMID: 23786770). 23786770
BRAF wild-type NRAS wild-type melanoma sensitive Lenvatinib Phase I Actionable In a Phase I clinical trial, Lenvima (lenvatinib) treatment resulted in stable disease in 44% (4/9) and partial response in 22% (2/9) of melanoma patients carrying wild-type BRAF and NRAS (PMID: 26169970). 26169970
Unknown unknown Advanced Solid Tumor not applicable Lenvatinib Phase I Actionable In a Phase I trial, Lenvima (lenvatinib) demonstrated safety and preliminary anti-tumor activity in patients with advanced solid tumors (PMID: 22516948). 22516948
Unknown unknown Advanced Solid Tumor not applicable Lenvatinib Phase I Actionable In a Phase I trial, Lenvima (lenvatinib) treatment resulted in partial response in 11.7% (9/77) and stable disease in 51.9% (40/77) of patients with advanced solid tumors (PMID: 26169970). 26169970
Clinical Trial Phase Therapies Title Recruitment Status
NCT02211222 Phase I Lenvatinib An Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer Approved for marketing
NCT02657369 Phase II Lenvatinib A Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC) Terminated
NCT01877083 Phase II Lenvatinib Study of the Safety and Activity of Lenvatinib (E7080) in Subjects With KIF5B-RET-Positive Adenocarcinoma of the Lung Completed
NCT03008369 Phase II Lenvatinib Lenvatinib in Treating Patients With Metastatic or Advanced Pheochromocytoma or Paraganglioma That Cannot Be Removed by Surgery Recruiting
NCT02702388 Phase II Lenvatinib Phase 2 Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 20 mg or 14 mg Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile Recruiting
NCT02846766 Phase II Lenvatinib Study of Lenvatinib in Patients With Advanced Cancer and Aberrations in FGF/FGFR Signaling Withdrawn
NCT03433703 Phase II Lenvatinib Trial to Evaluate Safety and Efficacy of Treatment of Physician Choice (TPC) Following First-Line Treatment of Lenvatinib in Subjects With Unresectable Hepatocellular Carcinoma (uHCC) Terminated
NCT03506048 Phase II Lenvatinib Lenvatinib and Iodine Therapy in Treating Patients With Radioactive Iodine-Sensitive Differentiated Thyroid Cancer Recruiting
NCT02432274 Phase Ib/II Etoposide Lenvatinib Cyclophosphamide Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies Recruiting
NCT01433991 Phase Ib/II Golvatinib Lenvatinib E7050 in Combination With E7080 in Subjects With Advanced Solid Tumors (Dose Escalation) and in Subjects With Recurrent Glioblastoma or Unresectable Stage III or Stage IV Melanoma After Prior Systemic Therapy (Expansion Cohort and Phase 2) Unknown status
NCT01761266 Phase III Lenvatinib Sorafenib A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable Hepatocellular Carcinoma Active, not recruiting
NCT02780310 Phase II Lenvatinib Testing Lenvatinib in Patients With Adenoid Cystic Carcinoma Active, not recruiting
NCT03713593 Phase III Lenvatinib Lenvatinib + Pembrolizumab Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002) Recruiting
NCT02501096 Phase Ib/II Pembrolizumab Lenvatinib Phase 1b/2 Trial of Lenvatinib (E7080) Plus Pembrolizumab in Subjects With Selected Solid Tumors Recruiting