Effect of isatuximab plus pomalidomide/dexamethasone on renal impairment in relapsed/refractory multiple myeloma: ICARIA-MM study subgroup analysis
Section snippets
Background
Renal impairment (RI) is a common feature in multiple myeloma (MM) and an adverse predictor of survival. Anti-myeloma treatments that can also improve renal function in patients (pts) with MM are required. ICARIA-MM was a randomized, open-label, active-controlled, multicenter phase 3 study that investigated the anti-CD38 monoclonal antibody isatuximab (Isa) in combination with pomalidomide and dexamethasone (Pd) in pts with relapsed/refractory MM (RRMM) and ≥2 prior lines of therapy
Methods
Pts had a baseline estimated glomerular filtration rate (eGFR) of ≥30 mL/min/1.73m2, (Modification of Diet in Renal Disease). Isa (10 mg/kg IV) was given on days 1, 8, 15, and 22 (cycle 1), and days 1 and 15 in subsequent 28-day cycles. All pts received standard doses of Pd in each cycle. The primary endpoint was PFS, assessed by an independent response committee. RI was defined as eGFR <60 mL/min/1.73 m2 (eGFR <60) at baseline. Complete renal response was defined as improvement in eGFR from
Results
307 pts were randomized to Isa-Pd (n=154) and Pd (n=153) of whom 55 (35.7%) and 49 (32.0%) pts had RI, respectively. Median PFS for pts with eGFR <60 was 9.5 months with Isa-Pd and 3.7 months with Pd (HR 0.50; 95% CI, 0.30–0.85). In pts with eGFR ≥60, median PFS was 12.7 months with Isa-Pd (n=87) and 7.9 months with Pd (n=96; HR 0.58; 95% CI, 0.38–0.88). In pts with eGFR <60, median OS was not reached in the Isa-Pd arm compared with 11.6 months in the Pd arm (HR 0.53; 95% CI, 0.30–0.96).The
Conclusion
The addition of Isa to Pd increased the number of pts with reversal of RI, sustained renal responses and improved PFS and ORR consistent with the benefit observed in the overall study population.
Keywords
CD38
Multiple myeloma
Renal impairment
Tracks
Treatment of Previously Treated Myeloma