Therapy Detail
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| Therapy Name | Nintedanib |
| Synonyms | |
| Therapy Description |
Ofev (nintedanib) is a triple angiokinase inhibitor that acts by blocking VEGFR, FGFR, RET, and PDGFR, thereby preventing tumorigenesis (PMID: 24947258, PMID: 24561444). Ofev (nintedanib) is FDA approved for use in patients with idiopathic pulmonary fibrosis (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Nintedanib | Ofev | BIBF 1120|Vargatef|BIBF 1120 | FGFR Inhibitor (Pan) 18 PDGFR Inhibitor (Pan) 27 RET Inhibitor 39 VEGFR Inhibitor (Pan) 32 | Ofev (nintedanib) is a triple angiokinase inhibitor that acts by blocking VEGFR, FGFR, RET, and PDGFR, thereby preventing tumorigenesis (PMID: 24947258, PMID: 24561444). Ofev (nintedanib) is FDA approved for use in patients with idiopathic pulmonary fibrosis (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FGFR3 Y375C | urinary bladder cancer | resistant | Nintedanib | Preclinical | Actionable | In a preclinical study, bladder cancer cells harboring FGFR3 Y375C were resistant to growth inhibition by Ofev (Nintedanib) in culture (PMID: 22238366). | 22238366 |
| FGFR2 act mut | Advanced Solid Tumor | decreased response | Nintedanib | Preclinical | Actionable | In a preclinical study, transformed cells expressing constitutively active FGFR2 demonstrated reduced sensitivity to Ofev (Nintedanib) in culture, when compared to other tyrosine kinase inhibitors (PMID: 22238366). | 22238366 |
| FGFR1 amp | estrogen-receptor positive breast cancer | sensitive | Nintedanib | Preclinical | Actionable | In a preclinical study, Ofev (nintedanib) inhibited the growth of ER-positive breast cancer cells harboring FGFR1 amplification in culture (PMID: 22238366). | 22238366 |
| Unknown unknown | pancreatic endocrine carcinoma | not applicable | Nintedanib | Preclinical | Actionable | In a preclinical study, Ofev (nintedanib) induced tumor cell apoptosis, decreased microvessel density, inhibited tumor growth, and improved survival in transgenic mouse models of pancreatic neuroendocrine carcinoma (PMID: 26206868). | 26206868 |
| FGFR2 amp | colon cancer | sensitive | Nintedanib | Preclinical | Actionable | In a preclinical study, Ofev (nintedanib) inhibited growth of colon cancer cells harboring FGFR2 amplification in culture (PMID: 22238366). | 22238366 |
| FGFR2 S252W | endometrial cancer | sensitive | Nintedanib | Preclinical | Actionable | In a preclinical study, Ofev (Nintedanib) inhibited cell proliferation in endometrial cancer cells harboring FGFR2 S252W mutation in culture (PMID: 22238366). | 22238366 |
| Unknown unknown | colorectal cancer | not applicable | Nintedanib | Phase I | Actionable | In a Phase I trial, Ofev (nintedanib) demonstrated safety and efficacy in patients with advanced colorectal cancer (PMID: 25012508). | 25012508 |
| Unknown unknown | pancreatic cancer | not applicable | Nintedanib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Nintedanib, alone or with chemotherapy, inhibited tumor growth in cell line xenograft models of lung and pancreatic cancer but not in cell culture (PMID: 23729403). | 23729403 |
| FGFR2 N549K | endometrial cancer | resistant | Nintedanib | Preclinical | Actionable | In a preclinical study, Ofev (Nintedanib) did not inhibit growth of endometrial cancer cells harboring FGFR2 N549K in cell culture (PMID: 22238366). | 22238366 |
| Unknown unknown | gastric adenocarcinoma | not applicable | Nintedanib | Phase II | Actionable | In a Phase II trial, Ofev (nintedanib) was well tolerated and the study met its primary endpoint, resulted in progression-free survival at 6-months in 19% (6/32) of patients with esophageal/GEJ (n=17) or gastric (n=15) adenocarcinoma, with a median follow-up of 14.5 months and a median overall survival of 14.2 months (PMID: 30952642; NCT02234596). | 30952642 |
| Unknown unknown | esophagus adenocarcinoma | not applicable | Nintedanib | Phase II | Actionable | In a Phase II trial, Ofev (nintedanib) was well tolerated and the study met its primary endpoint, resulted in progression-free survival at 6-months in 19% (6/32) of patients with esophageal/GEJ (n=17) or gastric (n=15) adenocarcinoma, with a median follow-up of 14.5 months and a median overall survival of 14.2 months (PMID: 30952642; NCT02234596). | 30952642 |
| FGFR1 act mut | Advanced Solid Tumor | decreased response | Nintedanib | Preclinical | Actionable | In a preclinical study, transformed cells expressing constitutively active FGFR1 demonstrated reduced sensitivity to Ofev (Nintedanib) in culture, when compared to other tyrosine kinase inhibitors (PMID: 22238366). | 22238366 |
| Unknown unknown | gastroesophageal junction adenocarcinoma | not applicable | Nintedanib | Phase II | Actionable | In a Phase II trial, Ofev (nintedanib) was well tolerated and the study met its primary endpoint, resulted in progression-free survival at 6-months in 19% (6/32) of patients with esophageal/GEJ (n=17) or gastric (n=15) adenocarcinoma, with a median follow-up of 14.5 months and a median overall survival of 14.2 months (PMID: 30952642; NCT02234596). | 30952642 |
| Unknown unknown | Advanced Solid Tumor | not applicable | Nintedanib | Phase I | Actionable | In a Phase I trial, Ofev (nintedanib) demonstrated safety and some preliminary efficacy in patients with advanced solid tumors (PMID: 25795637). | 25795637 |
| FGFR3 act mut | Advanced Solid Tumor | decreased response | Nintedanib | Preclinical | Actionable | In a preclinical study, transformed cells expressing constitutively active FGFR3 demonstrated reduced sensitivity to Ofev (Nintedanib) in culture, when compared to other tyrosine kinase inhibitors (PMID: 22238366). | 22238366 |
| Unknown unknown | lung adenocarcinoma | not applicable | Nintedanib | Phase III | Actionable | In a Phase III clinical trial, the combination of Ofev (nintedanib) and Taxotere (docetaxel) improved progression-free survival and overall survival in patients with lung adenocarcinoma compared to Taxotere (docetaxel) alone (PMID: 24411639). | 24411639 |
| Unknown unknown | lung cancer | not applicable | Nintedanib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Nintedanib, alone or with chemotherapy, inhibited tumor growth in cell line xenograft models of lung and pancreatic cancer but not in cell culture (PMID: 23729403). | 23729403 |
| Unknown unknown | Indication other than cancer | not applicable | Nintedanib | FDA approved | Actionable | Ofev (nintedanib) is FDA approved for use in patients with idiopathic pulmonary fibrosis (FDA.gov). | detail... detail... |
| FGFR3 S249C | urinary bladder cancer | resistant | Nintedanib | Preclinical | Actionable | In a preclinical study, bladder cancer cells harboring FGFR3 S249C were resistant to Ofev (Nintedanib) induced inhibition of cell proliferation in culture (PMID: 22238366). | 22238366 |
| Unknown unknown | brain glioma | not applicable | Nintedanib | Phase II | Actionable | In a Phase II clinical trial, Ofev (nintedanib) failed to show any efficacy in patients with recurrent high-grade glioma, regardless of prior bevacizumab therapy (PMID: 25338318). | 25338318 |
| Unknown unknown | ovarian cancer | not applicable | Nintedanib | Phase I | Actionable | In a Phase I clinical trial, Vargatef (nintedanib) demonstrated safety in patients with ovarian cancers, clinical trials to determine efficacy in these patients are ongoing (PMID: 19889612). | 19889612 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status |
|---|---|---|---|---|
| NCT02299141 | Phase I | Nintedanib | Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer | Active, not recruiting |
| NCT02665143 | Phase Ib/II | Cytarabine + Idarubicin Nintedanib | A Randomized Trial of a Combination of Nintedanib/Placebo in Combination With Induction Chemotherapy for Patients With Refractory or First Relapse Acute Myeloid Leukemia | Suspended |
| NCT02152059 | Phase II | Nintedanib | A Study to Evaluate the Good and Bad Effects of BIBF1120 in Small Cell Lung Cancer Patients Who Have Previously Benefited From First-line Platinum-based Chemotherapy | Withdrawn |
| NCT02149108 | Phase III | Nintedanib | Nintedanib (BIBF 1120) vs Placebo in Refractory Colorectal Cancer | Completed |
| NCT02399215 | Phase II | Nintedanib | Nintedanib in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors | Active, not recruiting |
| NCT02231164 | Phase III | Docetaxel Nintedanib | LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research | Terminated |
| NCT01669798 | Phase II | Nintedanib | BIBF 1120 in Bevacizumab Resistant, Persistent, or Recurrent Epithelial Ovarian Cancer | Completed |
| NCT02780700 | Phase II | Capecitabine + Nintedanib Nintedanib | Nintedanib Alone or in Combination With Capecitabine in Refractory Metastatic Colorectal Cancer [LUME-Colon 2] | Terminated |
| NCT02234596 | Phase II | Nintedanib | Nintedanib in Patients With Advanced Esophagogastric Cancer | Completed |
| NCT02389764 | Phase II | Nintedanib | Nintedanib For HER2-negative Metastatic Inflammatory Breast Cancer (MIBC) | Terminated |
| NCT02452463 | Phase II | Nintedanib | Nintedanib Compared With Placebo in Treating Against Radiation-Induced Pneumonitis in Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery and Are Undergoing Chemoradiation Therapy | Terminated |
| NCT02568449 | Phase II | Nintedanib | Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent | Active, not recruiting |
| NCT02902484 | Phase Ib/II | Gemcitabine + Nab-paclitaxel + Nintedanib Nintedanib | Study of Nintedanib and Chemotherapy for Advanced Pancreatic Cancer | Recruiting |
| NCT01907100 | Phase III | Cisplatin + Pemetrexed Disodium Nintedanib | Nintedanib (BIBF 1120) in Mesothelioma | Terminated |
| NCT01948141 | Phase II | Nintedanib | Nintedanib in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Up to Two Previous Chemotherapy Regimens | Completed |
| NCT03287947 | Phase II | Nintedanib | LCI-GI-APX-NIN-001: Nintedanib in Metastatic Appendiceal Carcinoma | Terminated |
| NCT02496585 | Phase II | Nintedanib Prednisone | Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis | Active, not recruiting |
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