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Adjusted LOA
ML Risk
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...