Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic GSK2130579A · 1 trial · 1 indication
Severe toxicities (as classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0) during the study treatment period defined as a study product-related or possibly study product-related: * Grade 4 toxicity (exception: study product-related or possibly study product-related Grade 4 fatigue - including lethargy, asthenia, and malaise - had to have a duration of at least 48 hours to be taken into account). * Grade 3 toxicity lasting for at least 48 hours (exceptions: myalgia, arthralgia, headache, and fever, regardless of duration). * Grade 2 toxicity (i.e., rash, flushing, urticaria, and dyspnea). Drug fever was not part of this definition. * Decrease in renal function, with a calculated creatinine clearance \< 40 mL/min. * Grade 2 cardiac ischemia/infarction (i.e., asymptomatic and testing suggesting ischemia; stable angina).
CR = having \< 5% blasts in aspirate sample with marrow spicules and with a count of ≥ 200 nucleated cells, no blasts with Auer rods or persistence of extramedullary disease; different phenotype (by flow cytometry) to the pre-treatment specimen; absolute neutrophil count \> 1000/mm3; platelet count ≥ 100 000/mm3 and being independent of red blood cell (RBC) transfusions. PR = a decrease of ≤ 50% in the % of blasts in bone marrow aspirate compared to Visit 4; being independent of RBC transfusions and the absolute neutrophil ≥ 1000/mm3 and platelet counts and ≥ 100 000/mm3. SD = no sufficient criteria for CR, a PR or Progressive disease (PD = Reappearance of leukemic blasts in the peripheral blood; Reappearance/development of cytologically proven extramedullary disease, Appearance of new dysplastic changes, or in a bone marrow aspirate sample (with marrow spicules and with a count of ≥200 nucleated cells) of ≥5% blasts; or, in case of early progression, a higher blast % than at Visit 4).
| Arm | Type | Description |
|---|---|---|
| Partial Remission Group | EXPERIMENTAL | Adult patients in partial remission post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals. |
| Complete Remission Group | EXPERIMENTAL | Adult patients in complete remission with incomplete blood count recovery post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2130579A | BIOLOGICAL | Intramuscular injection |
Inclusion Criteria: * The patient has cytologically proven AML as defined by the World Health Organization (WHO) classification. The pretreatment AML karyotype should be documented. * The leukemia is a de novo or secondary AML. * The patient's blasts cells show expression of WT1 transcript, detecte...
GSK2130579A is an investigational cancer immunotherapy developed by GSK plc for acute myeloid leukemia, also called acute myelocytic leukemia. It is a recombinant WT1 antigen-specific cancer immunotherapeutic designed to stimulate an immune response against the WT1 antigen. It was studied in a Phase 1 trial in adults with a suboptimal response to induction chemotherapy.
GSK2130579A was studied in adults with acute myeloid leukemia who had a suboptimal clinical response to induction chemotherapy. The Phase 1 trial enrolled 17 patients aged 18 years and older across the United States, France, and Germany. It is an investigational agent and is not an approved treatment for acute myeloid leukemia.
GSK2130579A targets the WT1 antigen. It is a recombinant WT1 antigen-specific cancer immunotherapeutic, meaning it is designed to direct an immune response against cells expressing the WT1 antigen. The agent is classified as a monoclonal antibody modality and was evaluated in acute myeloid leukemia.
GSK2130579A is developed by GSK plc, which trades under the ticker GSK. The company is listed as the developer of this recombinant WT1 antigen-specific cancer immunotherapeutic. Development was conducted through GSK Biologicals, the vaccines and immunotherapy unit of GSK.
GSK2130579A is in Phase 1 development. Its single clinical trial, NCT01051063, was a Phase 1 study that has been completed. The trial enrolled 17 patients and was not randomized and not double blinded, though it used a controlled design. The drug remains investigational and is not approved.
GSK2130579A has been evaluated in one clinical trial, NCT01051063, titled Evaluation of a New Anti-cancer Immunotherapy in Adult Acute Myeloid Leukemia Patients With a Suboptimal Clinical Response to Induction Chemotherapy. The Phase 1 study is completed, enrolled 17 participants, and took place in the United States, France, and Germany.