Isatuximab plus carfilzomib and dexamethasone in relapsed multiple myeloma patients with high-risk cytogenetics: IKEMA subgroup analysis.

8042 Background: A prespecified interim efficacy analysis of the Phase 3 IKEMA study (NCT03275285) demonstrated that isatuximab (Isa) + carfilzomib (K) and dexamethasone (d) (Isa-Kd) significantly improved progression-free survival (PFS) compared with Kd in patients (pts) relapsed multiple myeloma (RMM) (HR 0.531; 99% CI, 0.318–0.889; P= 0.0007), a clinically meaningful increase minimal residual disease negativity (MRD-) (29.6% vs 13.0%) complete response (CR) (39.7% 27.6%) rates, manageable safety profile. This subgroup examined pts high-risk cytogenetics [t(4;14), del(17p), t(14;16)] and/or gain(1q21). Methods: Pts 1–3 prior lines therapy were randomized 3:2 to receive Isa-Kd (n = 179) or 123). High-risk was assessed by central laboratory defined as ≥1 following: del(17p): 50% cutoff; t(4;14) t(14;16): 30% cutoff. Assessment gain(1q21) ≥3 copies: Results: Of pts, 23.5% 25.2% (Kd) had cytogenetic abnormality (CA); 26.3% isolated The addition Isa PFS for CA standard-risk (Table); 0.549; 95% 0.232–1.301) more pronounced treatment effect than del(17p) 0.837; 0.281–2.496). clear benefit also seen combined other (Table). trend toward CR, ≥very good partial (VGPR), MRD- rates alone. Grade treatment-emergent adverse events (TEAEs) common Kd, but incidence serious fatal TEAEs similar both arms Conclusions: CA, profile, consistent observed overall population. is potential new option difficult-to-treat RMM cytogenetics. Funding: Sanofi. Clinical trial information: NCT03275285. [Table: see text]