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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.

The NINLARO regimen is the only all-oral PI-based triplet approved for treatment to disease progression or unacceptable toxicity6,7

NINLARO IS A HIGHLY ACTIVE AGENT
Primary PFS analysis: NINLARO® (ixazomib) vs placebo
  • *NINLARO regimen extended median PFS by ~6 months vs the placebo regimen. Median PFS: 20.6 vs 14.7 months for the NINLARO and placebo regimens, respectively; HR=0.74 (95% CI, 0.59-0.94); P=0.012.1
  • 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
  • The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The placebo regimen included placebo+lenalidomide+dexamethasone.
  • NE=not evaluable; 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

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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 DISEASE PROGRESSION OR UNACCEPTABLE TOXICITY1,6,7

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

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 lab results
  • Key secondary endpoints included OS and OS in del(17p)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(17p), 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; PFS=progression-free survival; PI=proteasome inhibitor; ORR=overall response rate; OS=overall survival.

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
Tourmaline-MM1 selected baseline characteristics: NINLARO® (ixazomib) vs placebo
  • *The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The placebo regimen included placebo+lenalidomide+dexamethasone.
  • Stratification factor.
  • Many patients had moderate renal impairment
  • 23% of patients had light chain disease and 12% of patients had free light chain–measurable only disease
  • 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 placebo regimen, respectively
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

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Responses were rapid with the NINLARO® (ixazomib) regimen and deepened with continued treatment1

Depth of response: NINLARO® (ixazomib) vs placebo
  • *The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The placebo regimen included placebo+lenalidomide+dexamethasone.
    ORR=CR+VGPR+PR.
    CR=complete response; ORR=overall response rate; PR=partial response; VGPR=very good partial response.
48%

of patients achieved ≥VGPR WITH the NINLARO regimen.

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

 

Responses deepened with continued treatment1
  • Responses improved over time in both arms of the study1
  • 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

Positive PFS trends seen across selected prespecified subgroups

PFS ANALYSIS IN SELECTED PATIENTS: HAZARD RATIOS
  • Study limitations:
  • This study was not powered to show significance in PFS across these prespecified subgroups8
  • Cytogenetic risk data were not available for 24% of patients in the study1
  • Other prespecified subgroups not included in this figure were gender, race, region, Western countries, prior bortezomib exposure, thalidomide refractory, and creatinine clearance at baseline8
  • The PFS results in the above subgroups were consistent with those represented in the figure below8
NINLARO® (ixazomib) PFS-analysis: variable, subgroup and hazard ratio
Median PFS in prescribed subgroups
  • *Defined as patients with del(17p), t(4;14), and/or t(14;16).
    The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The placebo regimen included placebo+lenalidomide+dexamethasone.

Positive PFS trends were seen across certain prespecified subgroups, including patients aged 65 years or younger, those with standard-risk cytogenetics, and those with ECOG 0 or 1.”
—Dr. Antonio Palumbo

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