Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals' 2241658A Antigen-Specific Cancer Immunotherapeutic · 1 trial · 1 indication
Severe toxicity was defined, according to the Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0), as 1)an Antigen-Specific Cancer Immunotherapeutic (ASCI) related or possibly related Grade 3 or higher toxicity. Grade 3 myalgia, arthralgia, headache, fever, rigors/chills and fatigue (including lethargy, malaise and asthenia) should persist for 48 hours despite therapy to be taken into account and as 2)an ASCI related or possibly related Grade 2 or higher allergic reaction occurring within 24 hours of the dose administration.
Severe toxicity was defined, according to the Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0), as 1)an Antigen-Specific Cancer Immunotherapeutic (ASCI) related or possibly related Grade 3 or higher toxicity. Grade 3 myalgia, arthralgia, headache, fever, rigors/chills and fatigue (including lethargy, malaise and asthenia) should persist for 48 hours despite therapy in order to be taken into account and as 2)an ASCI related or possibly related Grade 2 or higher allergic reaction occurring within 24 hours of the dose administration. All active follow-up visits and procedures were stopped, hence this follow-up analysis was not performed as initially planned.
Best response was recorded from the start of treatment until disease progression. Response assessment was essentially based on a set of measurable lesions (target lesions \[TL\]), and any other lesions (non-target lesions \[NTL\]), both identified at baseline. Complete Response (CR)=disappearance of all TL or NTL; Partial Response (PR) = at least 30 percent (%) decrease in the sum of the longest diameter(LD) of TL compared to baseline, stable disease (SD) = neither sufficient shrinkage to qualify PR nor sufficient increase to qualify for Progressive disease (PD) compared with baseline; PD = at least 20% increase in the sum of LD of TL compared with baseline, or the appearance of one or more new lesions, or both of these, and/or unequivocal progression of existing NTL; NE =non-evaluable; Clinical response: any CR or PR best overall response; Disease control: any CR, PR, SD or SD/PR best overall response.
| Arm | Type | Description |
|---|---|---|
| NY-ESO 1 Group | EXPERIMENTAL | Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' 2241658A Antigen-Specific Cancer Immunotherapeutic (ASCI) | BIOLOGICAL | Up to 24 intramuscular administrations |
Inclusion Criteria: * Male or female patient with histologically proven, measurable metastatic cutaneous melanoma, and with documented progressive disease within the 12 weeks before the first administration of study treatment. * Written informed consent for NY-ESO-1 expression screening and gene pr...
Top 20 of 51 competitors
GSK Biologicals' 2241658A Antigen-Specific Cancer Immunotherapeutic is an investigational immunotherapy developed by GSK plc for melanoma, a form of skin cancer. It is a monoclonal antibody-based treatment designed to stimulate an antigen-specific immune response against cancer cells. It has been studied in patients with non-operable, progressing metastatic cutaneous melanoma.
It is being studied for the treatment of non-operable and progressing metastatic cutaneous melanoma in adults. The single Phase 1 trial enrolled patients with this advanced form of skin cancer. It is an investigational agent and is not an established treatment option for melanoma.
GSK Biologicals' 2241658A Antigen-Specific Cancer Immunotherapeutic is 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 immunotherapy candidate within GSK's pipeline.
GSK Biologicals' 2241658A Antigen-Specific Cancer Immunotherapeutic is in Phase 1 development. It is an investigational agent and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.
GSK Biologicals' 2241658A Antigen-Specific Cancer Immunotherapeutic was evaluated in one completed Phase 1 trial, NCT01213472, titled Evaluation of a New Anti-cancer Immunotherapy in Patients With Non-operable and Progressing Metastatic Cutaneous Melanoma. The trial enrolled 33 patients across Australia, Austria, France, Germany, Italy, the Netherlands, Switzerland, and the United Kingdom.
Yes. GSK Biologicals' 2241658A Antigen-Specific Cancer Immunotherapeutic is also known as GSK Biologicals' 2241658A ASCI, where ASCI stands for Antigen-Specific Cancer Immunotherapeutic. Both names refer to the same GSK plc Phase 1 melanoma immunotherapy candidate.