This site is intended for US
healthcare professionals only.

Important Safety Information Prescribing Information

Efficacy

EFFICACY

NINLARO® (ixazomib) is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

NINLARO® (ixazomib) is a highly active agent

The NINLARO 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).1
  • *The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The placebo regimen included placebo+lenalidomide+dexamethasone.

NE=not evaluable; OS=overall survival; PFS=progression-free survival.

Multiple myeloma is a disease you can't cure, so I think it's important to keep patients on treatment until progression or unacceptable toxicity."
—Dr. Robert Vescio

WATCH THE VIDEO

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 toxicity1,2

A global, phase 3, double-blind, placebo-controlled study of patients with relapsed and/or refractory MM (N=722)1

NINLARO® (ixazomib) - Tourmaline-MM1
  • *Defined as treatment to progression or unacceptable toxicity.
  • Stratification: 1 vs 2 or 3 prior therapies; PI exposed vs PI naïve; and ISS stage I 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 criteria1
  • Key secondary endpoints included OS and OS in del(17)1
  • Other secondary endpoints included ORR, PFS in patients with high-risk cytogenetics, and safety1
  • Patients who were refractory to lenalidomide or PIs were excluded from the study
  • 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.

Current data also suggest the value of long-term therapy."
—Dr. Ruben Niesvizky

LEARN MORE

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
  • *Stratification factor.
  • 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%

of patients were previously treated with bortezomib.

  • Patients who were refractory to lenalidomide or PIs were excluded from the study

When we look at the baseline characteristics as a whole, it's representative of the broad patient population we see in the relapsed setting."
—Dr. Ruben Niesvizky

WATCH THE VIDEO

Responses were rapid with NINLARO® (ixazomib) and deepened with continued treatment

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%

of patients achieved ≥VGPR WITH the NINLARO regimen.

TIME TO INITIAL RESPONSE
NINLARO® (ixazomib) - Initial Response

 

Responses deepened with continued treatment
  • Responses improved over time in both arms of the study1
  • The study was not powered to detect differences in response rates
NINLARO® (ixazomib) - Initial Response

PFS analysis in select patient populations1

  • This study was not powered to show significance in PFS across these prespecified subgroups
  • Other prespecified subgroups not included in this chart were gender, race, region, Western countries, prior bortezomib exposure, thalidomide refractory, creatinine clearance at baseline, and ECOG performance status3
  • The PFS results in these subgroups were consistent with those represented in this table3
  • Cytogenetic risk data were not available for 24% of patients in the study1
NINLARO® PFS-analysis

Positive PFS trends seen across select prespecified subgroups

MEDIAN PFS IN PRESPECIFIED SUBGROUPS (MONTHS)1,4,5

NINLARO® ninlaro-positive_PFS
  • *Defined as patients with del(17), t(4;14), and/or t(14;16).

Multiple myeloma is a disease you can't cure, so I think it's important to keep patients on treatment until progression or unacceptable toxicity."
—Dr. Robert Vescio

WATCH THE VIDEO