Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Talacotuzumab
Talacotuzumab/kg · 2 trials · 2 indications
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
Inclusion Criteria: * Myelodysplastic Syndrome (MDS) according to World Health Organization (WHO) criteria confirmed by bone marrow aspirate and biopsy within 12 weeks prior to first dose. A local laboratory report from this diagnostic bone marrow aspirate and biopsy must be approved by the sponsor...
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Talacotuzumab is an investigational monoclonal antibody being studied in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). It was evaluated in adults with AML who were ineligible for intensive chemotherapy and in transfusion-dependent participants with low or intermediate-1 risk MDS who had relapsed or were refractory to erythropoiesis-stimulating agent treatment.
Talacotuzumab targets IL3RA, also known as CD123, a receptor expressed on certain blood cell lineages. By binding this target, the monoclonal antibody is designed to act against leukemic and dysplastic cells that carry the receptor. It is being developed by Johnson & Johnson as an antibody-based therapy for myeloid malignancies.
Talacotuzumab is developed by Johnson & Johnson, which trades under the ticker JNJ. The compound is also identified in company materials as JNJ-56022473. Development has focused on hematologic malignancies, specifically acute myeloid leukemia and myelodysplastic syndromes, through the company's oncology pipeline.
Talacotuzumab is in Phase 2 development and is not approved for any indication. Both of its recorded clinical studies were Phase 2 trials, and both have completed. The program covers acute myeloid leukemia and myelodysplastic syndromes, with no active trials currently listed.
Talacotuzumab has been studied in two completed Phase 2 trials. NCT02472145 tested decitabine plus talacotuzumab versus decitabine alone in 326 participants with acute myeloid leukemia ineligible for intensive chemotherapy. NCT03011034 evaluated talacotuzumab or daratumumab in 34 transfusion-dependent participants with low or intermediate-1 risk myelodysplastic syndromes relapsed or refractory to erythropoiesis-stimulating agents.