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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 regimen 1,2

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 therapy 2

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 therapies 1

Adding oral NINLARO to Rd significantly extends PFS in RRMM patients1

At 14.7 months' median follow-up, oral NINLARO + Rd significantly extended median PFS by approximately 6 months compared with placebo + Rd1,2

  • Adding NINLARO to Rd delivered a clinically meaningful 35% improvement in PFS vs placebo + Rd (at the primary and final analysis)1
  • At 23 months' median follow-up, median OS was not reached in either group1,2
    • A planned interim analysis for OS at 23 months' median follow-up was conducted
    • There were 81 deaths in the NINLARO + Rd regimen and 90 deaths in the placebo + Rd regimen, representing 35% of the required number of deaths for the final OS analysis
    • Median OS was not reached in either regimen and follow-up is ongoing

Adding oral NINLARO to Rd delivered a clinically meaningful 35% improvement in PFS vs placebo + Rd at the primary and final PFS analysis1,2

Adapted from NINLARO Summary of Product Characteristics and Moreau et al. 20161,2

Adding oral NINLARO to Rd significantly extends PFS in RRMM patients treated with 2–3 prior lines of therapy5

In the pre-defined, stratified subgroup of patients who received 2–3 prior lines of therapy, PFS was significantly extended for NINLARO + Rd versus placebo + Rd (median not reached vs 12.9 months; HR 0.58, 95% CI 0.40–0.84, p=0.0033)5*

  • At 23 months' median follow-up, median OS was not reached for either group (HR 0.65, 95% CI 0.41–1.02)6

Adding oral NINLARO to Rd significantly extends PFS in RRMM patients

Adapted from Mateos et al. 2017.

*At 14.7 months' median follow up

Adding oral NINLARO to Rd extends PFS across a broad group of patients vs placebo + Rd1,2

  • A consistent effect on PFS with NINLARO + Rd was observed across a broad range of patients including:1,2
    • High‑risk cytogenetics
    • 2 to 3 prior lines
    • Prior Pl exposure
    • Mild-to-moderate renal impairment
  • As multiple myeloma is a heterogeneous disease, benefit may vary across subgroups2

Adding oral NINLARO to Rd extends PFS vs placebo + Rd across a broad group of patients1,2

Adapted from NINLARO Summary of Product Characteristics1

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

This study was not powered to show significance in PFS across these prespecified subgroups

Adding oral NINLARO to Rd extends PFS irrespective of patients' cytogenetic risk profile3

Adding oral NINLARO to Rd maintained the median PFS in patients with high‑risk cytogenetics, including those with del(17), to a similar level as standard risk patients3†

Adapted from Avet-Loiseau et al. 20163

† 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), t(4;14) and t(14;16) were defined by a percentage of positive cells that were above the technical background cut-offs of 5%, 3% and 3% respectively

Oral NINLARO + Rd patients responded rapidly2

Oral NINLARO + Rd patients responded after a median of ~1 cycle2‡

Adapted from NINLARO Summary of Product Characteristics2

‡ The duration of one cycle of NINLARO + Rd is 28 days

¥ Response of ≥PR

Oral NINLARO + Rd patients' responses deepened with sustained treatment4

Responses deepened with continued treatment with NINLARO + Rd4‡

Adapted from Supplementary Appendix to Moreau et al. 20164

‡The duration of one cycle of NINLARO + Rd is 28 days