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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). |
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). |
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 |
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 |