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Real-world efficacy of Isa-Kd in patients with RRMM
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The Isa-Kd regimen is approved by the U.S. FDA and the EMA for the treatment of patients with RRMM.1 This approval is based on results from the phase III IKEMA trial (NCT03275285), which were previously reported by the Multiple Myeloma Hub.1 However, data on the real-world efficacy of Isa-Kd are limited.1 An Italian, multicenter, retrospective analysis evaluated the safety and efficacy of Isa-Kd in a real-world population of 103 patients with RRMM.1 Results from this analysis were published in the European Journal of Haematology by De Novellis, et al.1 |
| Key learnings |
| The best ORR was 87%, with sCR/CR, VGPR, and PR rates of 18%, 39%, and 27%, respectively, and with a median time to best response of 3 months and a median number of cycles of 6. |
| The median PFS and OS were not reached, and the 1-year PFS and OS rates were 72% and 77%, respectively. |
| The safety findings were consistent with the safety profile of Isa-Kd in the IKEMA trial, with manageable rates of hematological (42%) and cardiac (24%) toxicities. |
| In a subgroup analysis of patients who received 1 prior line of therapy (n = 69), the best ORR, sCR/CR, VGPR, and PR rates were 88%, 20%, 46%, and 22%, respectively. Median PFS and OS were not reached, and the 1-year PFS and OS rates were 92% and 95%, respectively. |
| These results confirm the effectiveness of Isa-Kd in real-world patients with RRMM. The promising efficacy of Isa-Kd in patients with 1 prior line of therapy may influence therapeutic algorithms by encouraging Isa-Kd earlier in the treatment sequence for fit patients. |
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.
- De Novellis D, derudas D, Vincelli D, et al. Clinical efficacy of isatuximab plus carfilzomib and dexamethasone in relapsed/refractory multiple myeloma patients. Eur J Haematol. Online ahead of print. DOI: 10.1111/ejh.14314
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