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Ixazomib in combination with pomalidomide and dexamethasone in patients with lenalidomide-refractory MM: Results from the Alliance A061202 trial
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The randomized phase I/II Alliance A061202 trial (NCT02004275) assessed the safety and efficacy of the all-oral regimen of ixazomib, a proteasome inhibitor, in combination with pomalidomide plus dexamethasone in adult patients with lenalidomide-refractory multiple myeloma at first relapse.1 In the phase I portion, a maximum tolerated dose of 4 mg for both ixazomib and pomalidomide was confirmed.1 In phase II, patients were randomized 1:1 to receive IXA-POM-DEX (n = 38) or POM-DEX (n = 39).1 Results from phase II were published in Blood Advances by Voorhees et al.1 |
| Key learnings |
| The ORR in the IXA-POM-DEX arm was higher than in the POM-DEX arm (63.2% vs 43.6%), but this did not reach statistical significance. The ≥VGPR rate was higher in the IXA-POM-DEX arm vs the POM-DEX arm (28.9% vs 5.1%; p = 0.0063). |
| The median PFS was higher in the IXA-POM-DEX vs POM-DEX arm (20.3 months vs 7.5 months; HR, 0.437; upper 90% bound = 0.657), while the median OS was not reached in either arm, with 2-year OS rates of 78.4% vs 79.5% (p = 0.5522). |
| Grade 2–4 AEs were more common in the IXA-POM-DEX arm vs the POM-Dex arm, including neutropenia (71.1% vs 46.2%), lymphopenia (63.2% vs 35.9%), anemia (34.2% vs 20.5%), and thrombocytopenia (13.2% vs 5.1%). Grade ≥3 non-hematologic AEs were similar between the two arms. |
| Among the patients who crossed over from the POM-DEX arm to the IXA-POM-DEX arm at disease progression (n = 26), the ORR was 23.1% and the median PFS was 5.6 months. |
| These findings suggest that the addition of ixazomib to the POM-DEX regimen improves PFS in patients with lenalidomide-refractory multiple myeloma at first relapse. Phase III studies of this all-oral triplet regimen are warranted. Abbreviations: CR, complete response; EMA, European Medicines Agency; FDA, Food and Drug Administration; Isa-Kd, isatuximab, carfilzomib, and dexamethasone; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; RRMM, relapsed/refractory multiple myeloma; sCR, stringent CR; VGPR, very good PR. |
Abbreviations: AE, adverse event; HR, hazard ratio; IXA-POM-DEX, ixazomib, pomalidomide, dexamethasone; MM, multiple myeloma; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; POM-DEX, pomalidomide, dexamethasone; VGPR, very good partial response.
References
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