Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as JNJ-56022473
Talacotuzumab · 2 trials · 2 indications
Complete response rate defined as percentage of participants who achieved complete response as per modified International Working Group (IWG) criteria. CR: Bone marrow blasts less than (\<)5 percent (%); absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (\>)1.0\*10\^9/liter (L) (1000/micro liter \[mcL\]); platelet count \>100\*10\^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis.
Overall Survival (OS) was defined as the time from the date of randomization to date of death from any cause. Median Overall Survival was estimated by using the Kaplan-Meier method. This endpoint is reported here for Part B only as per the planned analysis.
Percentage of participants who achieved RBC TI lasting at least 8 weeks were reported. RBC TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization.
| Arm | Type | Description |
|---|---|---|
| Decitabine plus Talacotuzumab | EXPERIMENTAL | Part A: For Cycle 1 of Part A, participants will receive talacotuzumab on Day 1. Starting from Cycle 2 of Part A, participants may receive decitabine on Day 1, 2, 3, 4, and 5, and talacotuzumab on Day 8 and 22 of a 28-day cycle. Part B Arm 1: Participants will receive decitabine on Day 1, 2, 3, 4, and 5, and talacotuzumab on Day 8 and 22 of a 28-day cycle. |
| Decitabine | ACTIVE_COMPARATOR | Participants in Part B Arm 2 will receive decitabine on Day 1,2, 3, 4 and 5 of a 28-day cycle. |
| Talacotuzumab | EXPERIMENTAL | Participants will receive talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV) on Days 1 and 15 for all cycles. Each treatment cycle is of 28 days. The talacotuzumab arm of the study is closed for enrollment. |
| Daratumumab | EXPERIMENTAL | Participants will receive daratumumab 16 mg/kg IV on Days 1, 8, 15, and 22 for Cycles 1 and 2; on Days 1 and 15 for Cycles 3 to 6; and on Day 1 for all subsequent cycles. Each treatment cycle is of 28 days. |
| Name | Type | Description |
|---|---|---|
| Decitabine 20 mg/m^2 | DRUG | Decitabine 20 milligram per square meter (mg/\[m\^2\]) from Day 1, 2, 3, 4 and 5 of a 28-day cycle. |
| Talacotuzumab 9 mg/kg | DRUG | Talacotuzumab 9 milligram per kilogram mg/kg on Day 8 and 22 of a 28-day cycle. |
| Talacotuzumab | DRUG | Talacotuzumab 9 mg/kg will be administered as an IV infusion. |
| Daratumumab | DRUG | Daratumumab 16 mg/kg will be administered as an IV infusion. |
Inclusion Criteria: * De novo or secondary acute myeloid leukemia (AML) (post myelodysplastic syndrome \[MDS\] or myeloproliferative neoplasm \[MPN\] or after leukemogenic chemotherapy) according to WHO 2008 criteria For Part A: \- Participants With AML: treatment naive or relapsed for whom exper...
Talacotuzumab is an investigational biologic studied in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). It was tested in adults with AML who are ineligible for intensive chemotherapy and in transfusion-dependent participants with low or intermediate-1 risk MDS who are relapsed or refractory to erythropoiesis-stimulating agent treatment.
Talacotuzumab targets IL3RA, also known as CD123, a binding agent target on the interleukin-3 receptor alpha chain. The compound is also referred to as JNJ-56022473 in its clinical trial titles, where it is described as an anti-CD123 agent.
Talacotuzumab is developed by Johnson & Johnson, ticker JNJ. The company sponsored the clinical studies of the agent, which is identified as JNJ-56022473 in trial documentation.
Talacotuzumab reached Phase 2/3 clinical development. It is investigational and was studied in a Phase 2/3 trial in acute myeloid leukemia and a Phase 2 trial in myelodysplastic syndromes. Both listed studies are completed.
Talacotuzumab was studied in NCT02472145, a Phase 2/Phase 3 active-controlled trial of decitabine plus talacotuzumab versus decitabine alone in 326 participants with AML ineligible for intensive chemotherapy, and in NCT03011034, a Phase 2 trial in 34 participants with MDS relapsed or refractory to ESA treatment.