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NINLARO® (ixazomib) capsules 4mg I 3mg I 2.3mg

VELCADE® (bortezomib) FOR INJECTION

This site is intended for US healthcare professionals only.

Important Safety Information Prescribing Information
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This site is intended for US
healthcare professionals only.

Important Safety Information Prescribing Information

NINLARO® (ixazomib) capsules 4mg I 3mg I 2.3mg

VELCADE® (bortezomib) FOR INJECTION

This site is intended for US healthcare professionals only.

Important Safety Information Prescribing Information

EFFICACY

Indication: 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.

Limitations of Use: NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials.

The NINLARO regimen is the only all-oral, PI-based triplet approved for treatment to disease progression or unacceptable toxicity1,5,6

THE NINLARO REGIMEN PROLONGED PROGRESSION-FREE SURVIVAL VS Rd REGIMEN1,2
Primary PFS analysis: NINLARO® (ixazomib) vs placebo

Final OS Analysis

With a median follow-up of ~85 months, the median OS in the ITT population was 53.6 months for patients receiving the NINLARO regimen and 51.6 months for patients receiving the Rd regimen

HR=0.94 [95% CI: 0.78-1.13]1

  • Results demonstrated in a global, phase 3, randomized, double-blind, placebo-controlled study of patients with relapsed and/or refractory multiple myeloma treated to disease progression or unacceptable toxicity (N=722).1,2
  • The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The Rd regimen included placebo+lenalidomide+dexamethasone.
  • CI=confidence interval; HR=hazard ratio; mPFS=median PFS; NE=not evaluable; PFS=progression-free survival; OS=overall survival.

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

TOURMALINE-MM1 IS THE FIRST CLINICAL TRIAL USING AN ALL-ORAL PI-BASED TREATMENT TO DISEASE PROGRESSION OR UNACCEPTABLE TOXICITY1,2,5,6

A global, phase 3, randomized, double-blind, placebo-controlled study of patients with relapsed and/or refractory multiple myeloma (N=722)1,2

TOURMALINE-MM1 clinical trial study design
  • *Defined as treatment to disease progression or unacceptable toxicity.
  • Stratification: 1 vs 2 or 3 prior therapies; PI exposed vs PI naive; and ISS stage I or II vs III.
  • The primary endpoint of PFS, according to 2011 IMWG criteria, was assessed every 4 weeks until disease progression by a blinded IRC and was based on central laboratory results1
  • Key secondary endpoints included OS and OS in del(17p)2
  • Other secondary endpoints included ORR, PFS in patients with high-risk cytogenetics, and safety2
  • Patients who were refractory to lenalidomide or PIs were excluded from the study2
  • Defined as patients with del(17p), t(4;14), and/or t(14;16).
    ECOG=Eastern Cooperative Oncology Group performance status; IMWG=International Myeloma Working Group; IRC=independent review committee; ISS=International Staging System; MM=multiple myeloma; ORR=overall response rate; OS=overall survival; PI=proteasome inhibitor.

TOURMALINE-MM1 included difficult-to-treat patients1

Patients with primary refractory multiple myeloma, high-risk cytogenetics, free light chain disease, and renal impairment were included
TOURMALINE-MM1 selected baseline characteristics: NINLARO® (ixazomib) vs placebo
  • *The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The Rd regimen included placebo+lenalidomide+dexamethasone.
  • Stratification factor.
  • Cutoff values for high-risk cytogenetic markers, including del(17p), t(4;14), and t(14;16), were performed by a central laboratory2
  • Positivity for del(17p) was defined by a percentage of positive cells that were above the technical background cutoff of 5%2
  • Many patients had renal impairment1
  • 23% of patients had light chain disease and 12% of patients had free light chain-measurable only disease1
  • 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 regimen and the Rd regimen, respectively1
  • Patients who were refractory to lenalidomide or PIs were excluded from the study

The NINLARO® (ixazomib) regimen* achieved rapid responses that deepened with continued treatment1,2

Depth of response: NINLARO® (ixazomib) vs placebo
  • *The NINLARO (ixazomib) regimen included NINLARO+lenalidomide+dexamethasone. The Rd regimen included placebo+lenalidomide+dexamethasone.
    Versus the Rd regimen.
    CR=complete response; ORR=overall response rate; PR=partial response; VGPR=very good partial response.
78%

of patients achieved ORR WITH the NINLARO regimen.

THE NINLARO REGIMEN ACHIEVED RAPID RESPONSES VS THE Rd REGIMEN
Median time to initial response: NINLARO® (ixazomib) vs placebo

 

Responses deepened with continued treatment1,2
  • Depth of response for the NINLARO vs Rd regimens, respectively: ORR: 78% vs 72%; CR: 12% vs 7%; VGPR+CR: 48% vs 39%; PR: 30% vs 33%1
  • Responses improved over time in both arms of the study2
  • Study limitation: The study was not powered to detect differences in response rates between arms
NINLARO® (ixazomib) arm: cumulative best responses over time in the intent-to-treat population
  • CR=complete response; ORR=overall response rate; PR=partial response; VGPR=very good partial response.

Positive PFS trends seen across selected prespecified subgroups2,8,9

PFS ANALYSIS IN SELECTED PATIENTS: HAZARD RATIOS
  • Study limitations:
  • This study was not powered to show significance in PFS across these prespecified subgroups7
  • Cytogenetic risk data were not available for 24% of patients in the study2
  • Other prespecified subgroups not included in this figure were gender, race, region, Western countries, prior bortezomib exposure, thalidomide refractory, and creatinine clearance at baseline7
  • The PFS results in the above subgroups were consistent with those represented in the figure below7
NINLARO® (ixazomib): PFS subgroup analysis
  • *Median PFS (months).
  • Defined as patients with del(17p), t(4;14), and/or t(14;16).
  • The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The Rd regimen included placebo+lenalidomide+dexamethasone.
  • ECOG=Eastern Cooperative Oncology Group; ISS=International Staging System.
Median PFS in prespecified subgroups
  • §Defined as patients with del(17p), t(4;14), and/or t(14;16).
    The NINLARO regimen includes NINLARO+lenalidomide+dexamethasone. The Rd regimen included placebo+lenalidomide+dexamethasone.
  • CI=confidence interval; HR=hazard ratio; mPFS=median progression-free survival; PFS=progression-free survival.