Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic · 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: 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). * An allergic reaction/hypersensitivity 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).
Seropostivity rate was defined as the number of patients with anti-WT1 antibody concentration greater than or equal to (≥) the cut-off value of 9 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL).
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).
Treatment response was defined as: For initially seronegative patients: post-administration antibody concentration ≥ 9 EU/ML; For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.
| Arm | Type | Description |
|---|---|---|
| GSK2130579A Group | EXPERIMENTAL | Patients with cytologically proven AML, as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) | BIOLOGICAL | Intramuscular administration |
Inclusion Criteria: * The patient has cytologically proven AML, as defined by the WHO classification. The pretreatment AML karyotype should be documented. * The leukemia could be a de novo or secondary AML. * The patient received induction and consolidation therapy according to the Institution's st...
It is an investigational immunotherapy being studied in adults with acute myeloid leukemia (AML), a cancer of the blood and bone marrow. The Phase 1 trial evaluated it after chemotherapy in adult AML patients. It is not an approved treatment and remains in clinical development.
The therapy is being developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the company's vaccines and biologics unit. The asset is an oncology program within GSK's pipeline.
It is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The program has not advanced beyond Phase 1, and the therapy is investigational rather than approved.
It was studied in a single completed Phase 1 trial, NCT00725283, titled Evaluation of a New Anti-cancer Immunotherapy After Chemotherapy in Adult Patients With Acute Myeloid Leukemia (AML). The trial enrolled 34 adults aged 18 years and older in the United States and France.
NCT00725283 was an uncontrolled, non-randomized, open-label Phase 1 trial, meaning all 34 enrolled patients received the immunotherapy after chemotherapy. It was not blinded and had no comparator arm. The trial enrolled adults with acute myeloid leukemia in the United States and France and is now completed.