Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Talacotuzumab · 1 trial · 1 indication
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 |
|---|---|---|
| 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 |
|---|---|---|
| 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: * 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 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.