Trial Results

Efficacy for SARCLISA + Pd vs Pd alone

PFS ORR

Significant increase in median PFS demonstrated with SARCLISA + Pd
vs Pd alone

PFS (primary endpoint)1

Kaplan-Meier curve: 11.53 months (95% CI: 8.94, 13.9), median PFS with SARCLISA + Pd (n=154) vs 6.47 months (95% CI: 4.47, 8.28) with Pd alone (n=153); HR=0.596 (95% CI: 0.44, 0.81), P=0.0010.

PFS results were assessed by an IRC, based on central laboratory data for M-protein, and central radiologic imaging review using the IMWG criteria. Median follow-up was 11.6 months.1

40% reduction in the risk of disease progression or death in patients treated with SARCLISA + Pd1

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SARCLISA + Pd improved ORR and ≥VGPR vs Pd alone

ORR (secondary endpoint)1,a

ORR: 60.4% (95% CI: 52.2%, 68.2%) with SARCLISA + Pd (n=154) vs 35.3% (95% CI: 27.8%, 43.4%) with Pd alone (n=153); P<0.0001.

asCR, CR, VGPR, and PR were evaluated by the IRC using the IMWG response criteria.

bSARCLISA + Pd (95% CI: 52.2%, 68.2%), Pd (95% CI: 27.8%, 43.4%). 95% CI estimated using the Clopper-Pearson method.

cStratified by age (<75 years vs ≥75 years) and number of previous lines of therapy (2 or 3 vs >3) according to interactive response technology.

  • The median duration of treatment was 41 weeks for the SARCLISA + Pd group compared with 24 weeks for the Pd group1
  • Median OS was not reached for either treatment group at interim analysis1

Median time to first response was 35 days in the SARCLISA + Pd arm vs 58 days in the Pd arm1

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CR=complete response; IMWG=International Myeloma Working Group; IRC=independent response committee; ISS=International Staging System; ORR=overall survival; Pd=pomalidomide and dexamethasone; PFS=progression-free survival; PR=partial response; sCR=stringent complete response; VGPR=very good partial response.

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