EFFICACY

Extend progression-free survival

The NINLARO® (ixazomib) regimen* extended median PFS by ~6 months vs the placebo regimen* in relapsed and/or refractory multiple myeloma
NINLARO® (ixazomib) - Progression-Free Survival
  • At a median follow-up of 23 months, a planned interim OS analysis and noninferential PFS analysis were conducted. No OS advantage was observed; data were immature and the study remains ongoing. The PFS analysis supported a clinical benefit of the NINLARO regimen (median PFS: 20 months vs 15.9 months; HR=0.82 [95% CI, 0.67-1.0]).
  • Results demonstrated in a global, phase 3, double-blind, placebo-controlled study of patients with relapsed and/or refractory multiple myeloma treated to progression or unacceptable toxicity (N=722).
  • *The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The placebo regimen included placebo+lenalidomide+dexamethasone.

The NINLARO® (ixazomib) regimen demonstrated rapid responses

TIME TO INITIAL RESPONSE
NINLARO® (ixazomib) - Initial Response
DEPTH OF RESPONSE
NINLARO® (ixazomib) - Response Rate
  • *ORR=CR+PR, including VGPR.

    CR=complete response; ORR=overall response rate; PR=partial response; VGPR=very good partial response.
48%

48% of patients achieved ≥VGPR WITH the NINLARO regimen.

TOURMALINE-MM1 evaluated long-term treatment* with the NINLARO® (ixazomib) regimen

TOURMALINE-MM1 is the first clinical trial using an all-oral, PI-based treatment to progression or unacceptable toxicity2

A global, phase 3, double-blind, placebo-controlled study of patients with relapsed and/or refractory MM (N=722)

NINLARO® (ixazomib) - Tourmaline-MM1
  • Stratification: 1 vs 2 or 3 prior therapies; PI exposed vs PI naïve; and ISS stage 1 or II vs III.
  • The primary endpoint of PFS was assessed every 4 weeks until disease progression by a blinded IRC based on central lab results according to 2011 IMWG criteria4
  • Key secondary endpoints included OS and OS in del(17)4
  • Other secondary endpoints included ORR, PFS in patients with high-risk cytogenetics, and safety4
  • Patients who were refractory to lenalidomide or PIs were excluded from the study


  • *Defined as treatment to progression or unacceptable toxicity.
  • Defined as patients with del(17), t(4;14), and/or t(14;16). ECOG=Eastern Cooperative Oncology Group; IMWG=International Myeloma Working Group; IRC=independent review committee; ISS=International Staging System; MM=multiple myeloma; PI=proteasome inhibitor.

TOURMALINE-MM1 included a broad range of patients

Patients with primary refractory multiple myeloma, high-risk cytogenetics, free light chain disease, and renal impairment were included
NINLARO® (ixazomib) - Tourmaline-MM1 Baseline
  • Primary refractory was defined as best response of stable disease or disease progression on all prior lines of therapy. Primary refractory status was documented in 7% and 6% of patients in the NINLARO® (ixazomib) regimen and the placebo regimen, respectively
  • 23% of patients had light chain disease and 12% of patients had free light chain–measurable only disease
  • Many patients had moderate renal impairment
69%

69% of patients were previously treated with bortezomib.

  • Patients who were refractory to lenalidomide or PIs were excluded from the study
  • *Stratification factor.