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Therapy Name Lenvatinib
Synonyms
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, in combination with Keytruda (pembrolizumab) as first line, or with Afinitor (everolimus) for renal cell carcinoma, and in combination with Pembrolizumab for endometrial carcinoma that is not MSI-H or dMMR (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Lenvatinib Lenvima E7080 FGFR Inhibitor (Pan) 26 KIT Inhibitor 57 PDGFR Inhibitor (Pan) 30 RET Inhibitor 53 VEGFR Inhibitor (Pan) 36 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, in combination with Keytruda (pembrolizumab) as first line, or with Afinitor (everolimus) for renal cell carcinoma, and in combination with Pembrolizumab for endometrial carcinoma that is not MSI-H or dMMR (FDA.gov).

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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
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
FGFR2 T370_A371delinsC intrahepatic cholangiocarcinoma predicted - sensitive Lenvatinib Case Reports/Case Series Actionable In a clinical case study, Lenvima (lenvatinib) treatment resulted in a reduction in tumor burden and ongoing response at 11.6 months in a patient with intrahepatic cholangiocarcinoma harboring FGFR2 T370_A371delinsC (PMID: 34480077). 34480077
FGFR2 S372C cholangiocarcinoma predicted - sensitive Lenvatinib Case Reports/Case Series Actionable In a clinical case study, Lenvima (lenvatinib) treatment resulted in a partial response in a patient with cholangiocarcinoma harboring FGFR2 S372C (PMID: 38346946). 38346946
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
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
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
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
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
BRAF wild-type NRAS mut 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
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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04428151 Phase II Lenvatinib + Pembrolizumab Docetaxel Paclitaxel Capecitabine Cetuximab Lenvatinib Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009) Active, not recruiting USA | ROU | NOR | ISR | GBR | FRA | ESP | DNK | CAN | BRA | AUS 4
NCT03878524 Phase I Oxaliplatin Palbociclib Vemurafenib Sirolimus Tretinoin Celecoxib Ipilimumab Ruxolitinib Dasatinib Abiraterone Idelalisib Trametinib Imatinib Erlotinib Carboplatin Olaparib Panobinostat Bortezomib Afatinib Fluorouracil Vorinostat Pembrolizumab Leucovorin Enzalutamide Ponatinib Nivolumab Everolimus Sunitinib Cabazitaxel Cabozantinib Lenvatinib Pertuzumab Sorafenib Venetoclax Bevacizumab A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART) Terminated USA 0
NCT01877083 Phase II Lenvatinib Study of the Safety and Activity of Lenvatinib (E7080) in Subjects With KIF5B-RET-Positive Adenocarcinoma of the Lung Completed USA 4
NCT02432274 Phase Ib/II Etoposide Lenvatinib Cyclophosphamide Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies Completed USA | ITA | GBR | FRA | ESP | DEU 0
NCT05949424 FDA approved Lenvatinib Olaparib Pazopanib Palbociclib Sunitinib OPTI - DOSE: Optimal Dosing of Oral Anticancer Drugs in Older Adults (OPTI-DOSE) Not yet recruiting NLD 0
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) Terminated USA 0
NCT02846766 Phase II Lenvatinib Study of Lenvatinib in Patients With Advanced Cancer and Aberrations in FGF/FGFR Signaling Withdrawn USA 0
NCT03008369 Phase II Lenvatinib Lenvatinib in Treating Patients With Metastatic or Advanced Pheochromocytoma or Paraganglioma That Cannot Be Removed by Surgery Completed USA 0
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 Completed USA | POL | ITA | ISR | GBR | FRA | ESP | DEU | CAN | BEL | AUS 10
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 USA 0
NCT05064280 Phase II Lenvatinib Pembrolizumab Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases Recruiting USA 0
NCT05103904 Phase II Lenvatinib Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant Recruiting USA 0
NCT03477175 Phase II Lenvatinib Study to Assess the Long-term Safety of Lenvatinib Monotherapy, a Lenvatinib Combination Regimen, or a Comparator Treatment Arm to Cancer Patients in Eisai Sponsored Lenvatinib Trials Completed USA | ROU | POL | NLD | ITA | DEU | BEL | AUS 3
NCT05168163 Phase II Atezolizumab + Cabozantinib Cabozantinib Atezolizumab + Lenvatinib Lenvatinib Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer Recruiting USA 0
NCT05822752 Phase II Lenvatinib Sorafenib ABBV-151 + Budigalimab Study to Evaluate Adverse Events, and Change in Disease Activity, When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Budigalimab in Adult Participants With Hepatocellular Carcinoma (HCC) Active, not recruiting USA | ITA | FRA | ESP 3
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) Completed USA | TUR | POL | NZL | ITA | IRL | GBR | FRA | ESP | DEU | CAN | AUS 9
NCT02780310 Phase II Lenvatinib Testing Lenvatinib in Patients With Adenoid Cystic Carcinoma Active, not recruiting USA 0
NCT05901194 Phase Ib/II Lenvatinib Lenvatinib Treatment in Waiting List of Liver Transplantation After TACE Failure in Patients With Hepatocellular Carcinoma (Ta-Len-Tra) Not yet recruiting FRA 0
NCT03506048 Phase II Lenvatinib Lenvatinib and Iodine Therapy in Treating Patients With Radioactive Iodine-Sensitive Differentiated Thyroid Cancer Terminated USA 0
NCT04008797 Phase I Lenvatinib E7386 + Lenvatinib A Study of E7386 in Combination With Other Anticancer Drug in Participants With Solid Tumor Recruiting USA | FRA 3
NCT05171335 Phase II Lenvatinib Neoadjuvant Combination Therapy of Lenvatinib and TACE for Transplant-Eligible Large Hepatocellular Carcinoma Patients Enrolling by invitation USA 0
NCT03976375 Phase III Lenvatinib Lenvatinib + Pembrolizumab Docetaxel Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008) Completed USA | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DEU | CAN | AUS | ARG 6
NCT04194775 Phase III CS1003 + Lenvatinib Lenvatinib A Study of CS1003 in Subjects With Advanced Hepatocellular Carcinoma Active, not recruiting USA | POL | ITA | ESP 2
NCT02211222 Phase I Lenvatinib An Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer Approved for marketing USA 0
NCT05188118 Phase I Cabozantinib Nivolumab Everolimus Ipilimumab Lenvatinib Rapid Sequencing of Approved Therapies in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma Recruiting USA 0
NCT05185739 Phase II Lenvatinib + Pembrolizumab Lenvatinib Pembrolizumab Perioperative Pembrolizumab and Lenvatinib in Resectable Hepatocellular Carcinoma (HCC) (PRIMER-1) Recruiting GBR 0
NCT04447755 Phase II Lenvatinib A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080) (E7080-G000-231) Active, not recruiting USA | TUR | SWE | NZL | ITA | ISR | HUN | HRV | FRA | ESP | CZE | BEL | AUS | ARG 6
NCT02501096 Phase Ib/II Pembrolizumab Lenvatinib Phase 1b/2 Trial of Lenvatinib (E7080) Plus Pembrolizumab in Subjects With Selected Solid Tumors Completed USA | NOR | ESP 0
NCT04193553 Phase II Lenvatinib Multicentre Placebo-controlled Double-blinded Phase II Study of Lenvatinib Efficacy in Patients With Locally Advanced or Metastatic GIST (Gastrointestinal Stromal Tumor) After Imatinib/Sunitinib Failure (LENVAGIST) Completed FRA 0
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 Completed USA | SWE | ROU | POL | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CAN | BEL | AUS 2
NCT04039607 Phase III Lenvatinib Sorafenib Ipilimumab + Nivolumab A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma (CheckMate 9DW) Active, not recruiting USA | ROU | POL | NZL | ITA | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG 9
NCT04321954 Phase II Lenvatinib Lenvatinib in Locally Advanced Invasive Thyroid Cancer Recruiting USA 0
NCT05113186 Phase II Lenvatinib Neoadjuvant and Adjuvant Lenvatinib in HCC Patients Treated by Percutaneous Ablative (LENVABLA) Active, not recruiting FRA 0
NCT02657369 Phase II Lenvatinib A Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC) Terminated USA | ITA | GBR | FRA | AUS 0


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