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Vol. 45. Núm. S4.
HEMO 2023
Páginas S400 (outubro 2023)
Vol. 45. Núm. S4.
HEMO 2023
Páginas S400 (outubro 2023)
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LONG-TERM OUTCOMES WITH ISATUXIMAB-CARFILZOMIB-DEXAMETHASONE IN RELAPSED MULTIPLE MYELOMA PATIENTS WITH 1Q21+ STATUS: UPDATED RESULTS FROM THE PHASE 3 IKEMA STUDY
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E Crusoea, T Faconb, P Moreauc, I Spickad, K Suzukie, K Yongf, J Mikhaelg, T Fukaoh, N Armstrongi, T Martinj
a Hospital Universitario Professor Edgar Santos (HUPES), Salvador, Brazil; Rede D'or Oncologia, Salvador, Brazil
b Lille University Hospital, Lille, France
c University Hospital Hôtel-Dieu, Nantes, France
d 1st Faculty of Medicine, Charles University and General Hospital, Prague, Czech Republic
e Japanese Red Cross Medical Center, Tokyo, Japan
f University College Hospital, London, United Kingdom
g Translational Genomics Research Institute (TGen), City of Hope Cancer Center, Phoenix, United States
h Sanofi, Global Oncology, Cambridge, United States
i Sanofi, Global Medical Affairs, Cambridge, United States
j University of California San Francisco Medical Center, San Francisco, United States
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Vol. 45. Núm S4

HEMO 2023

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Objectives

Gain or amplification of 1q21 (1q21+, ≥3 copies), a chromosomal abnormality frequently observed in multiple myeloma (MM), has a negative impact on prognosis due to its potential involvement in resistance to MM therapy and disease progression. In this subgroup analysis of IKEMA, we evaluated efficacy of isatuximab-carfilzomib-dexamethasone (Isa-Kd) in patients (pts) with 1q21+ status (with or without high-risk chromosomal abnormalities [HRCA]) and related subgroups – isolated 1q21+ (≥ 3 copies without HRCA), gain(1q21), amp(1q21) – at long-term follow-up (44.2 months).

Methods

Pts with 1–3 prior lines of therapy were randomized to Isa-Kd (n = 179) or Kd (n = 123). Assessment was prespecified (at 30% cutoff by FISH) for 1q21+ status as ≥3 copies, gain(1q21) as 3 copies, and amp(1q21) as ≥4 copies.

Results

In the Isa-Kd and Kd arms, 41.9% and 42.3% of pts had 1q21+ status, 26.3% and 25.2% isolated 1q21+, 24.0% and 30.1% gain(1q21), 17.9% and 12.2% amp(1q21) respectively. Greater progression-free survival (PFS) benefit was achieved with Isa-Kd vs Kd in pts with 1q21+ status (hazard ratio [HR] 0.58, 95% CI 0.37–0.92) and in pts with isolated 1q21+, gain(1q21), or amp(1q21). Responses deepened by adding Isa to Kd, with increased rates of very good partial response or better (≥VGPR), complete response or better (≥CR), minimal residual disease negativity (MRD-), and MRD- ≥CR.

Discussion

In the prespecified, long-term analysis of the Phase 3 IKEMA trial in relapsed MM pts, treatment with Isa-Kd showed continued, significant improvement in PFS compared to Kd (HR 0.58; 95.4% CI 0.42–0.79). There was a meaningful increase in the depth of response (≥CR 44.1% vs 28.5%; MRD- 33.5% vs 15.4%, MRD- ≥CR 26.3% vs 12.2%), and a manageable safety profile. The present study demonstrated that Isa-Kd led to deeper responses, with higher ≥VGPR rates, MRD-, and MRD- ≥CR rates in 1q21+ patients (with or without HRCA), isolated 1q21+, gain(1q21), or amp(1q21) compared to Kd. These long-term findings support Isa-Kd as an effective treatment option for patients with relapsed MM, including 1q21+ abnormalities and a higher risk of progression.

Conclusions

1q21 abnormalities may affect PFS in MM pts. Our results at long-term follow-up of pts with 1q21+ status (with or without HRCA) in the IKEMA study continue to show greater PFS benefit and deeper responses with Isa-Kd than Kd, consistent with the overall population and earlier 1q21+ subgroup interim analyses. Thus, they support Isa-Kd as an effective treatment option also for difficult-to-treat, 1q21+ pts with relapsed MM.

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Hematology, Transfusion and Cell Therapy
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