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Recombinant PRAME protein combined with the AS15 Adjuvant System GSK2302032A · 1 trial · 1 indication
Time to occurrence of any recurrence of disease was expressed in terms of rate: Person-year rate in each group = number of patients reporting at least one recurrence of disease (n)/ sum of follow-up period expressed in years (T\[year)\]) As a consequence of the decision to stop the PRAME-AS15-NSC-002 (ADJ) study, not all data were available for a full analysis. The median follow-up time was 10.3 months in the GSK2302032A group and 5.7 months in the Placebo group. Considering that two Phase III studies with recMAGE-A3 + AS15 failed to demonstrate clinical efficacy of the MAGE-A3 antigen specific cancer immunotherapeutic, GSK decided to stop the development of all recombinant protein based cancer vaccines and to stop recruitment in all the ongoing clinical studies.
| Arm | Type | Description |
|---|---|---|
| GSK2302032A Group | EXPERIMENTAL | The patients received 13 administrations GSK2302032A product, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks. |
| Placebo group | PLACEBO_COMPARATOR | The patients received 13 administrations of a placebo, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Recombinant PRAME protein combined with the AS15 Adjuvant System GSK2302032A | BIOLOGICAL | Intramuscular administration |
| Placebo | BIOLOGICAL | Intramuscular administration |
Inclusion Criteria: * The patient has radically resected NSCLC * The NSCLC is of pathological stage IA-T1b, IB, II or IIIA NSCLC The surgical technique for resection of the patient's tumor is anatomical, involving at least a segmentectomy The patient's tumor shows expression of PRAME. * The patient...
GSK2302032A is an investigational immunotherapy being studied in non-small cell lung cancer. It was evaluated in patients whose tumor had been surgically removed, an adjuvant setting intended to reduce the risk of cancer returning. It is not approved and remains in clinical development.
GSK2302032A combines a recombinant PRAME protein with the AS15 Adjuvant System. PRAME, or preferentially expressed antigen of melanoma, is the antigen the immune response is directed against. The AS15 Adjuvant System is included to stimulate the immune response to that recombinant protein.
GSK2302032A is being developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 2 study of the agent in non-small cell lung cancer.
GSK2302032A is in Phase 2 development. The single trial conducted with this agent has been completed, and no trials are currently active. The drug is investigational and has not been approved for any indication.
GSK2302032A was studied in one Phase 2 trial, NCT01853878, titled a study to demonstrate the benefit of PRAME immunotherapy for patients with non-small cell lung cancer after removal of their tumor. That trial is completed. It enrolled 137 patients across the United States, Estonia, France, Germany, Japan, Poland, Russia, South Korea, and the United Kingdom.
NCT01853878 was a randomized, double-blind, placebo-controlled Phase 2 trial in non-small cell lung cancer. It enrolled 137 participants aged 18 years and older, of all sexes, and did not use biomarker selection. The study is completed.