Extended Efficacy. Extended Possibilities.
NINLARO + Rd significantly extends PFS vs Rd alone and offers a manageable side effect profile with the convenience of an all‑oral regimen1,2
NINLARO is the first and only oral PI licensed in combination with Rd for the treatment of adult patients with MM who have received at least 1 prior therapy2
Oral NINLARO was studied in a broad group of RRMM patients who were treated to progression.1 TOURMALINE‑MM1 is the first global, phase III, double‑blind, placebo‑controlled study investigating an oral PI in RRMM patients. The trial compared NINLARO + Rd as part of an all‑oral regimen versus placebo + Rd in 722 RRMM patients treated with 1‑3 prior therapies1
TOURMALINE‑MM1 — the first global, phase III, double‑blind, placebo-controlled study investigating an oral PI in RRMM patients1
TOURMALINE‑MM1 enrolled a broad group of RRMM patients who were treated to progression1
The trial compared NINLARO + Rd as part of an all-oral regimen versus placebo + Rd in 722 RRMM patients treated with 1-3 prior therapies1
* Stratification: 1 vs 2 or 3 prior therapies; PI exposed vs PI naive; and International Staging System (ISS) stage I or II vs III1,2
† Defined as patients with del(17), t(4;14) or t(14;16)1
Oral NINLARO was studied in a broad group of RRMM patients, including patients with high‑risk cytogenetics and mild-to-moderate renal impairment1,2
- Clinical laboratory evaluations for high‑risk cytogenetic markers, including del(17), t(4;14) and t(14;16) were performed by a central laboratory. Positivity for del(17) was defined by a percentage of positive cells that were above the technical background cut-off of 5%
Key inclusion criteria:1
Measurable disease by at least one of:
- Serum or urine protein electrophoresis
- Free light chain assay
Relapsed and/or refractory disease:*
- Including primary refractory patients (no response to all therapies)
- Patients who had received 1-3 prior treatments
Creatinine clearance ≥30 mL/min
Key exclusion criteria:
Refractory to previous PI-based or lenalidomide-based treatment
*Refractory = progression of disease on treatment or within 60 days after last dose of therapy
- Moreau P, Masszi T, Grzasko N. N Engl J Med. 2016;374:1621-34.
- NINLARO (ixazomib capsules) Summary of Product Characteristics.