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- Title
MM-130: Updates from ICARIA-MM, a Phase 3 Study of Isatuximab (Isa) Plus Pomalidomide and Low-Dose Dexamethasone (Pd) vs Pd in Relapsed and Refractory Multiple Myeloma (RRMM).
- Authors
Richardson, Paul G.; Perrot, Aurore; San-Miguel, Jesus; Beksac, Meral; Spicka, Ivan; Leleu, Xavier; Schjesvold, Fredrik; Moreau, Philippe; Dimopoulos, Meletios A.; Huang, Jeffrey Shang-Yi; Minarik, Jiri; Cavo, Michele; Prince, H Miles; Cheng Zheng; Dubin, Franck; van De Velde, Helgi; Anderson, Kenneth C.
- Abstract
Isa is an approved monoclonal antibody that binds to a specific epitope on the CD38 receptor. Phase 3 ICARIA-MM study (NCT02990338) demonstrated improved progression-free survival (PFS) with Isa-Pd vs Pd (P=0.001) and manageable safety profile. Here, we report updated ICARIA results. Patients with RRMM (N=307) who received ≥2 prior therapies, including lenalidomide (Len) and a proteasome inhibitor (PI), were randomized to Isa-Pd (n=154) or Pd (n=153). Isa was administered intravenously at 10 mg/kg weekly for 4 weeks and every other week thereafter. This pre-planned second interim analysis assessed time to next treatment (TTNT), overall survival (OS), time from randomization to disease progression on first subsequent therapy or death (PFS2), and safety. Patients had median 3 prior lines of therapy. As of Oct 1, 2020 (median follow-up, 35.3 months), 27 Isa-Pd patients (18%) vs 12 Pd patients (8%) were still on treatment; 60% vs 72% proceeded to subsequent therapy. Median TTNT: 15.5 months Isa-Pd vs 8.9 months Pd (HR 0.56; 95% CI 0.42–0.74; P<0.0001); 24% vs 58% of patients with subsequent therapy received daratumumab. Overall response rate (ORR) in subsequent treatment with daratumumab monotherapy was lower in Isa-Pd vs Pd (14% vs 38%) but similar (31% vs 32%) with daratumumab combination therapy (+immunomodulator, +alkylator, +PI). Median PFS2 in ITT: 17.5 months Isa-Pd vs 12.9 months Pd (HR 0.76; 95% CI 0.58–0.99; P=0.0202). Median OS: 24.6 months Isa-Pd vs 17.7 months Pd (HR 0.76; 95% CI 0.58–1.01; one-sided P=0.0280). Median treatment duration: 47.6 weeks (1.3–171.6) Isa-Pd vs 24.0 weeks (1.0–168.6) Pd. Serious treatment-emergent adverse event (TEAEs): 73% Isa-Pd vs 60% Pd. Most frequent non-hematologic TEAEs (any grade) with Isa-Pd: infusion reaction (38%), URTI (34%), diarrhea (30%). Grade 3–4 neutropenia (85% vs 71%) and thrombocytopenia (34% vs 25%) were more frequent with Isa-Pd. Isa-Pd demonstrates significant improvement in TTNT and PFS2 vs Pd. A strong trend in OS benefit was seen in the Isa-Pd arm, with approximately 7 months improvement in median OS. The OS profile remains unchanged from prior analyses.
- Publication
Clinical Lymphoma, Myeloma & Leukemia, 2021, Vol 21, pS423
- ISSN
2152-2650
- Publication type
Article
- DOI
10.1016/S2152-2650(21)01948-0