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European commission approves lenalidomide and pomalidomide triplets for multiple myeloma
The European Commission has approved two triplet regimens for the treatment of multiple myeloma. The first is lenalidomide + bortezomib + dexamethastone (RVd) and the second is pomalidomide + bortezomib + dexamethasone (PVd). Both regimens previously received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).1
The approved indication for RVd is in patients with newly diagnosed multiple myeloma (NDMM) who are non-transplant eligible. This is based on the results of SWOG S0777 phase III trial results shown in Table 1.1,2
Table 1: Summary of the SWOG S0777 trial2
|
Trial name |
SWOG S0777 |
|---|---|
|
NCT reference |
|
|
Phase |
III |
|
Number of patients (N) |
525 |
|
Randomization |
1:1 - VRd:Rd |
|
Dosing VRd
|
Eight 21-day cycles Intravenous (IV) bortezomib 1.3 mg/m2, on days 1, 4, 8 and 11 Oral lenalidomide 25 mg, on days 1–14 Oral dexamethasone 20 mg, on days 1, 2, 4, 5, 8, 9, 11 and 12 |
|
Dosing Rd |
Six 28-day cycles Oral lenalidomide 25 mg, on days 1–21: Oral dexamethasone 40 mg on days 1, 8, 15 and 22 |
|
Maintenance |
Oral lenalidomide 25 mg once daily for 21 days Oral dexamethasone 40 mg once daily for days 1, 8, 15 and 22 of each 28-day cycle |
|
Efficacy (given as VRd vs Rd) |
Median progression-free survival (PFS): 43 vs 30 months (HR 0.712, 96% CI, 0.56–0.906, P = 0.0018) Median overall survival (OS): 75 vs 64 months (HR 0·709, 95% CI 0·524–0·959, P = 0.025) Overall response rate (ORR): 82% vs 72% Complete response (CR): 16% vs 8% |
|
Safety |
Consistent with the individual safety profiles of each drug alone Most common grade ≥3 events that were partially attributable to treatment: - Hematological: anemia, lymphopenia, neutropenia and thrombocytopenia - Non-hematological: fatigue, sensory neuropathy, hyperglycemia, thrombosis or embolism, hypokalemia, muscle weakness, diarrhea and dehydration
Neurological events: more frequent in VRd group compared to Rd group (33% vs 11%, P < 0.0001) |
The approved indication of PVd is in patients with MM who have received ≥1 prior treatment including lenalidomide. This approval is based on the OPTIMISMM phase III trial results, shown in Table 2.1,3
Table 2: Summary of the OPTIMISMM trial3
|
Trial name |
OPTIMISMM |
|---|---|
|
NCT reference |
|
|
Phase |
III |
|
Number of patients (N) |
559 71% vs 69% of patients were refractory to lenalidomide (PVd vs Vd arm) |
|
Randomization |
1:1 - PVd:Vd – patients were stratified based on age, anti-myeloma treatment and β-microglobulin levels |
|
Dosing PVd
|
21-day cycles: Pomalidomide 4 mg daily on days 1–14 Bortezomib 1.3 mg/m2 on days 1, 4, 8 and 11 of cycles 1–8 and on days 1 and 8 of cycle 9 onwards: Dexamethasone 20 mg (dose was 10 mg for patients > 75 years old) on the same day and the day after bortezomib in all 21-day cycles |
|
Efficacy (given as PVd vs Vd) |
Median follow-up: 16 months Median PFS: 11.2 vs 7.1 months 39% reduction in the risk of disease progression or death (HR 0.61, 95% CI, 0.49–0.77, P ≤ 0.001) |
|
Subgroup analysis in patients with one prior line of therapy |
Median PFS: 20.73 vs 11.63 months (HR 0.54, P = 0.0027) Benefit of PVd was independent of whether patients were refractory or non-refractory to prior lenalidomide |
|
Safety |
Consistent with the individual safety profiles of each drug alone |
These approvals will increase the options available to patients with NDMM in Europe.
References