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 toxicity^6,7

• ^*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

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

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

• ^*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

• ^*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

• 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

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

• ^*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.

 

• 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

Positive PFS trends seen across selected
prespecified subgroups

• 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

• ^*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