Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Talacotuzumab/kg · 1 trial · 1 indication
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 |
|---|---|---|
| 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 |
|---|---|---|
| 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: * 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 oncology drug being studied for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). It is being evaluated in patients with AML who are ineligible for intensive chemotherapy, and in those with transfusion-dependent low or intermediate-1 risk MDS who are relapsed or refractory to erythropoiesis-stimulating agent treatment.
Talacotuzumab is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 2 clinical development for oncology indications.
Talacotuzumab is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, one in acute myeloid leukemia and one in myelodysplastic syndromes.
Talacotuzumab has been studied in two completed Phase 2 trials. NCT02472145 evaluated decitabine plus talacotuzumab versus decitabine alone in 326 adults aged 65 and older with acute myeloid leukemia. NCT03011034 evaluated talacotuzumab or daratumumab in 34 adults with myelodysplastic syndromes.
Yes, Talacotuzumab is also known as JNJ-56022473. Both names refer to the same investigational drug, and the clinical trials use the JNJ-56022473 designation in their titles.