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Also known as Group 1: Epoetin alfa
Epoetin Alfa · 44 trials · 43 indications
Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a \> 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients.
Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cut off were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last disease assessment prior to the missing interval. Participants who withdrew from the study (withdrawal of consent or lost to follow-up) without progression were censored at the time of the last disease assessment.
| Arm | Type | Description |
|---|---|---|
| Epoetin alfa | EXPERIMENTAL | Group 1: Epoetin alfa type = range unit= IU/Kg number= 337.5 to 1050 IU/Kg form= solution for injection route= subcutaneous use weekly injections (max 40 000 IU per week for first 8 weeks of treatment max 80 000 IU per week later) using pre-filled 1mL 40 000 IU syringes for 24 to 48 weeks |
| No treatment | PLACEBO_COMPARATOR | Group 2: Placebo form= solution for injection route= subcutaneous use weekly injections for 24 to 48 weeks |
| Arm A (lenalidomide) | ACTIVE_COMPARATOR | Patients receive lenalidomide PO QD on days 1-21. Patients undergo bone marrow biopsy at screening and during follow-up. Patients undergo blood specimen collection on study. |
| Arm B (lenalidomide, epoetin alfa) | EXPERIMENTAL | Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly. Patients undergo bone marrow biopsy at screening and during follow-up. Patients undergo blood specimen collection on study. |
| 001 | EXPERIMENTAL | epoetin alfa Continue pre-study once weekly dose of epoetin alfa for 36 weeks |
| 003 | EXPERIMENTAL | epoetin alfa Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk |
| 002 | EXPERIMENTAL | epoetin alfa Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks |
| Group 2 | OTHER | Standard treatment of anemia excluding use of erythropoetin stimulating agents (ESAs). |
| Name | Type | Description |
|---|---|---|
| Group 2: Placebo | DRUG | form= solution for injection, route= subcutaneous use, weekly injections for 24 to 48 weeks |
| Group 1: Epoetin alfa | DRUG | type = range, unit= IU/Kg, number= 337.5 to 1050 IU/Kg, form= solution for injection, route= subcutaneous use, weekly injections (max 40,000 IU per week for first 8 weeks of treatment, max 80,000 IU per week later) using pre-filled 1mL 40,000 IU syringes for 24 to 48 weeks |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow biopsy |
| Epoetin Alfa | BIOLOGICAL | Given SC |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Lenalidomide | DRUG | Given PO |
| Standard supportive care (packed RBC transfusion) | OTHER | Per doctor prescription |
| epoetin alfa + packed RBC transfusion | DRUG | 40,000 IU SC once a week. |
| Standard of care | OTHER | - |
Inclusion Criteria: * Diagnosis of MDS according to World Health Organization or French-American-British pathologic classification (confirmed via bone marrow aspirate/biopsy) within 12 weeks prior to screening * Documentation of an International Prognostic Scoring System score indicating Low- or In...
Top 6 of 8 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | Luspatercept |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE3 | Elritercept |
| Disc Medicine, Inc. | IRON | 2 | PHASE2 | DISC-0974 |
| Akebia Therapeutics, Inc. | AKBA | 2 | PHASE3 | Vadadustat |
| Incyte Corporation | INCY | 1 | PHASE1 | INCB000928, Ruxolitinib |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | APG-5918 |
Epoetin alfa is used to treat anemia in patients with chronic kidney disease, myelodysplastic syndromes, and anemia related to cancer or chemotherapy. It is also studied in patients with acquired immunodeficiency syndrome and in settings involving blood transfusion. Its clinical development spans hematology indications including breast cancer and other cancers.
Epoetin alfa is developed by Johnson & Johnson, which trades under the ticker JNJ. The company has sponsored clinical trials of the drug across anemia and related hematology indications.
Epoetin alfa is in Phase 2 development according to the current pipeline status. It is an investigational asset in this context and has been studied across 28 clinical trials, all of which are completed, with no active trials currently listed.
Epoetin alfa has been evaluated in completed trials including NCT01381809, a Phase 3 study in anemic patients with myelodysplastic syndromes; NCT00641589, a Phase 1 pharmacokinetic and pharmacodynamic study in chronic kidney disease; NCT00446576, a Phase 3 study of cardiac function and quality of life in early renal disease; and NCT00440466, a Phase 3 extended dosing study in pre-dialysis CKD patients.
Across 28 completed clinical trials, epoetin alfa has enrolled a total of 6,485 patients. The trials include randomized and double-blind designs, and enrollment has spanned indications such as anemia, chronic kidney disease, and myelodysplastic syndromes.