Therapy Detail
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| Therapy Name | Ramucirumab |
| Synonyms | |
| Therapy Description |
Cyramza (ramucirumab) is a monoclonal antibody, which binds and inhibits VEGFR2 (KDR) resulting in decreased angiogenesis (PMID: 24094768). Cyramza (ramucirumab) is approved for gastric and gastroesophageal junction adenocarcinoma, non-small cell lung cancer, hepatocellular carcinoma, and colorectal cancer (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Ramucirumab | Cyramza | LY3009806 | VEGFR2 Antibody 4 | Cyramza (ramucirumab) is a monoclonal antibody, which binds and inhibits VEGFR2 (KDR) resulting in decreased angiogenesis (PMID: 24094768). Cyramza (ramucirumab) is FDA approved for use as a monotherapy or in combination with paclitaxel in patients with gastric or gastroesophageal junction adenocarcinoma who progressed on chemotherapy, in combination with erlotinib as first-line therapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations or L858R, in combination with decetaxel in patients with NSCLC who progressed on prior therapy, in combination with FOLFIRI in patients with colorectal cancer who progressed on prior therapy, and as monotherapy in patients with hepatocellular carcinoma who have received sorafenib (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| KDR wild-type | Advanced Solid Tumor | predicted - sensitive | Ramucirumab | Phase I | Actionable | In a Phase I trial, Cyramza (ramucirumab), an inhibitor of KDR (VEGFR2), demonstrated safety and efficacy (partial response or stable disease) in patients with advanced solid tumors (PMID: 20048182). | 20048182 |
| Unknown unknown | thyroid gland papillary carcinoma | not applicable | Ramucirumab | Phase I | Actionable | In a Phase I trial, Cyramza (ramucirumab) demonstrated safety and efficacy resulting in partial response or stable disease in patients with advanced solid tumors, including papillary thyroid carcinoma (PMID: 20048182). | 20048182 |
| Unknown unknown | ovary epithelial cancer | not applicable | Ramucirumab | Phase II | Actionable | In a Phase II trial, Cyramza (ramucirumab) resulted in antitumor activity in patients with epithelial ovarian cancer (PMID: 25016924). | 25016924 |
| Unknown unknown | duodenum adenocarcinoma | not applicable | Ramucirumab | Phase II | Actionable | In a Phase II study, Cyramza (ramuciramab), in combination with mFOLFOX-6 chemotherapy regimen (Wellcovorin (leucovorin), Adrucil (fluorouracil) and Eloxatin (oxaliplatin)), demonstrated safety and efficacy in metastatic colorectal cancer (PMID: 24674871). | 24674871 |
| Unknown unknown | gastroesophageal junction adenocarcinoma | not applicable | Ramucirumab | FDA approved | Actionable | In a Phase III trial (REGARD) that supported FDA approval, treatment with Cyramza (ramucirumab) improved median overall survival (5.2 vs 3.8 mo, HR=0.776, p=0.047) in aptients with compared to placebo in patients with advanced gastric or gastro-oesophageal junction adenocarcinoma whose disease progressed after chemotherapy (PMID: 24094768; NCT00917384). | 24094768 detail... |
| Unknown unknown | biliary tract cancer | not applicable | Ramucirumab | Phase II | Actionable | In a Phase II trial, Cyramza (ramucirumab) treatment resulted in a progression-free survival of 2.73 months, an overall survival of 6.31 months, 0% objective response rate, and a disease control rate of 44% (15/34) in patients with advanced biliary cancer(J Clin Oncol 36, 2018 (suppl; abstr 4081); NCT02520141). | detail... |
| Unknown unknown | hepatocellular carcinoma | not applicable | Ramucirumab | Phase III | Actionable | In a Phase III trial (REACH), treatment with Cyramza (ramucirumab) did not result in improved overall survival (OS) compared to placebo (9.2 vs. 7.6 months; HR 0.87 [95% CI 0.72-1.05]; p=0.14) in patients with hepatocellular carcinoma (PMID: 26095784). However, potential benefit on OS (HR 0.80, p=0.06) was observed in patients with a Child-Pugh score of 5 (PMID: 27657674; NCT01140347). | 26095784 27657674 |
| Unknown unknown | hepatocellular carcinoma | not applicable | Ramucirumab | FDA approved | Actionable | In a Phase III trial (REACH-2) that supported FDA approval, Cyramza (ramucirumab) treatment resulted in significantly improved overall survival (8.7 vs 7.3 months, HR=0.71, p=0.0199) and progression-free survival (2.8 vs 1.6 months, HR=0.452, p<0.0001) in hepatocellular carcinoma patients with baseline AFP of 400 ng/ml or higher, and progressed on or were intolerant to Nexavar (sorafenib) (PMID: 30665869; NCT02435433). | 30665869 detail... |
| Unknown unknown | gastric adenocarcinoma | not applicable | Ramucirumab | FDA approved | Actionable | In a Phase III trial (REGARD) that supported FDA approval, treatment with Cyramza (ramucirumab) improved median overall survival (5.2 vs 3.8 mo, HR=0.776, p=0.047) in aptients with compared to placebo in patients with advanced gastric or gastro-oesophageal junction adenocarcinoma whose disease progressed after chemotherapy (PMID: 24094768; NCT00917384). | 24094768 detail... |
| Unknown unknown | melanoma | not applicable | Ramucirumab | Phase II | Actionable | In a Phase II trial, Cyramza (ramucirumab), with or without Deticene (dacarbazine), demonstrated safety and efficacy in patients with metastatic melanoma. The combined therapy appeared to be associated with improved progression free survival relative to monotherapy (J Clin Oncol 28:15s, 2010 (suppl; abstr 8519)). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02079636 | Phase I | LY3023414 Abemaciclib Gemcitabine Pemetrexed Disodium Ramucirumab | A Study of LY2835219 in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC) | Completed | USA | 1 |
| NCT02443883 | Phase II | Ramucirumab | A Phase 2 Study of Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Junction (GEJ) Cancer | Completed | USA | 11 |
| NCT02065765 | Phase II | Ramucirumab | International Expanded Access Program to Provide Ramucirumab for the Treatment of Metastatic Gastric Cancer | No longer available | 5 | |
| NCT02520141 | Phase II | Ramucirumab | Ramucirumab for Advanced Pre-treated Biliary Cancers | Active, not recruiting | USA | 0 |
| NCT03904108 | Phase II | Ramucirumab | Platinum-Based Chemotherapy Plus Ramucirumab in Patients With Advanced NSCLC Who Have Progressed on First Line Anti-PD-1 Immunotherapy | Recruiting | USA | 0 |
| NCT02597036 | Phase I | LY3127804 Ramucirumab | A Study of LY3127804 With Ramucirumab in Participants With Advanced Solid Tumors | Completed | USA | 3 |
| NCT02314117 | Phase III | Capecitabine Fluorouracil Cisplatin Ramucirumab | A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer | Completed | USA | CAN | 18 |
| NCT02514551 | Phase II | Paclitaxel Ramucirumab | A Study of Ramucirumab (LY3009806) in Combination With Paclitaxel in Participants With Gastric Cancer | Completed | USA | CAN | 9 |
| NCT02426125 | Phase III | Ramucirumab Docetaxel | A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer | Active, not recruiting | USA | CAN | 21 |
| NCT04557384 | Phase I | Ramucirumab | A Study of Ramucirumab (LY3009806) Given by Injection Under the Skin in Participants With Advanced Cancer | Not yet recruiting | USA | 1 |
| NCT02564198 | Phase I | Ramucirumab | A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors | Completed | USA | 0 |
| NCT02581215 | Phase II | Ramucirumab Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin | Phase II Randomized Trial of FOLFIRINOX +/- Ramucirumab in Advanced Pancreatic Cancer | Active, not recruiting | USA | 0 |
| NCT02711553 | Phase II | Ramucirumab Merestinib Cisplatin + Gemcitabine | A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer | Active, not recruiting | USA | 18 |
| NCT02435433 | Phase III | Ramucirumab | A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (REACH-2) | Recruiting | USA | CAN | 18 |
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