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
- *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
TOURMALINE-MM1 evaluated long-term* treatment with the all-oral NINLARO® (ixazomib) regimen
- *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
- *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
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
The NINLARO® (ixazomib) regimen* achieved rapid responses† that deepened with continued treatment1,2
- *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.
of patients achieved ORR WITH the NINLARO regimen.
Positive PFS trends seen across selected
- 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
- *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.