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

VELCADE® (bortezomib) FOR INJECTION

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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

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 toxicity1,7,8

THE NINLARO REGIMEN PROLONGED PROGRESSION-FREE SURVIVAL VS Rd REGIMEN1,2
Primary PFS analysis: NINLARO® (ixazomib) vs placebo
  • *NINLARO regimen extended median PFS by ~6 months vs the Rd regimen. Median PFS: 20.6 vs 14.7 months for the NINLARO and Rd regimens, respectively; HR=0.74 (95% CI, 0.59-0.94); P=0.012.1,2
  • 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.
  • mPFS=median progression-free survival; NE=not evaluable.

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 all-oral NINLARO® (ixazomib) regimen

TOURMALINE-MM1 IS THE FIRST CLINICAL TRIAL USING AN ALL-ORAL PI-BASED TREATMENT TO DISEASE PROGRESSION OR UNACCEPTABLE TOXICITY1,2,7,8

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
69%

of patients were previously treated with VELCADE® (bortezomib)2.

  • 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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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.

NINLARO 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
  • ORR=CR+VGPR+PR.

Positive PFS trends seen across selected prespecified subgroups2,9,10

PFS ANALYSIS IN SELECTED PATIENTS: HAZARD RATIOS
  • Study limitations:
  • This study was not powered to show significance in PFS across these prespecified subgroups9
  • 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 baseline9
  • The PFS results in the above subgroups were consistent with those represented in the figure below9
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.

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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