Placebo-controlled phase III trial of patient-specific immunotherapy with mitumprotimut-T and granulocyte-macrophage colony-stimulating factor after rituximab in patients with follicular lymphoma
Freedman A et al. - Study demonstrates that time to progression (TTP) was shorter with mitumprotimut-T/GM-CSF compared with placebo/GM-CSF in patients with CD20+ follicular lymphoma. This difference was possibly due to the imbalance in Follicular Lymphoma International Prognostic Index (FLIPI) scores. Methods- Aim was to evaluate patient-specific immunotherapy with mitumprotimut-T and GM-CSF in CD20+ follicular lymphoma
- Patients: treatment-naive or relapsed/refractory disease achieving a CR, PR, or SD with 4 weekly rituximab infusions
- Pts randomly assigned to mitumprotimut-T/GM-CSF or placebo/GM-CSF
- Doses: monthly for 6 doses, every 2 mo for 6 doses, and then every 3 mo until disease progression (PD)
- Randomization was stratified by prior therapy and response to rituximab
- Primary end point: TTP from randomization
Results- 349 pts; median age: 54 yrs; 79% were treatment naive, and 86% had stage III/IV disease
- Median TTP was 9.0 mo for mitumprotimut-T/GM-CSF and 12.6 mo for placebo/GM-CSF
- TTP was comparable between the 2 arms in treatment-naive pts and shorter with mitumprotimut-T/GM-CSF in relapsed/refractory disease
- After adjusting for FLIPI scores, the difference in TTP between the 2 arms was no longer significant
- Overall objective response rate, rate of response improvement, and duration of response were comparable between the 2 arms
- Toxicity was similar in the 2 arms:
- 76% of adverse events were mild or moderate, and
- 94% of patients had injection site reactions
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