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PHASE 3 TRIAL

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

TOURMALINE‑MM1 study design1

TOURMALINE-MM1 study design

* 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

Patients enrolled in TOURMALINE‑MM11,2

* Stratification factor 2

A patient who received both a prior PI and a prior IMiD would count for both categories 2

Primary refractory, defined as patients that were refractory to all lines of previous treatment(s) (ie. patients who have never responded to any therapies received), was documented in 7% and 6% of patients in the NINLARO and placebo regimens, respectively. Patients refractory to PIs or lenalidomide were excluded 1,2

§ Defined as patients with del(17), t(4;14) or t(14;16)1

  • 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%