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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

Oral NINLARO + Rd is generally well-tolerated with manageable side effects1

Adverse events were generally Grade 1 or 2 and were manageable with supportive care1

  • The most frequently reported adverse events were GI, rash, thrombocytopenia, peripheral oedema, peripheral neuropathy (PN) and back pain1
    • They were generally Grade 1 and 2 and manageable with supportive care
    • No CV or renal safety signals seen in the study
  • Thrombocytopenia was increased in the NINLARO + Rd vs placebo + Rd arm, but did not result in an increase in bleeding events or platelet transfusions2
  • The incidence of Grade ≥3 PN was 2% across both NINLARO + Rd and placebo + Rd1,2

Adverse events (AEs) occurring in ≥5% of patients with a ≥5% difference between oral NINLARO + Rd and placebo + Rd1*

Adapted from Moreau et al. 20161

*At 23 months' median follow-upRepresents multiple MedDRA preferred terms

Eye disorders were reported with many different preferred terms but in aggregate, the frequency was 26% in patients in the NINLARO regimen and 16% of patients in the placebo regimen1

 

 

Oral NINLARO + Rd is generally well tolerated with manageable side effects in patients who have received 2-3 prior lines of therapy1,7

All-grade AEs were consistent with the safety population1,7

AEs (any grade) occurring in ≥5% of patients with a ≥5% difference between oral NINLARO + Rd and placebo + Rd

Adapted from Mateos et al. 2017 and Moreau et al. 2016

*Constipation, back pain and upper respiratory tract infection not reported for 2-3 prior lines population

†Figure based on high-level term for rashes, eruptions and exanthems

Common Grade ≥3 adverse events (≥5% in any patient subgroup) within the overall and stratified 2-3 prior lines subgroup

Adapted from Mateos et al. 2017 and Moreau et al. 2016

  • In the 2-3 prior lines subgroup, rates of Grade ≥3 peripheral neuropathy were 3% vs 1% and rash 3% and <1% for NINLARO + Rd vs placebo +Rd, respectively

Most patients were able to continue on extended oral NINLARO + Rd treatment3

Most patients were able to continue extended oral NINLARO + Rd treatment without dose modifications3

  • The majority of patients (76%) continued at their starting dose of NINLARO without dose reduction3
  • The median relative dose intensity of NINLARO was high and similar to placebo (97.4% and 98.8%, respectively) at 23 months' median follow-up4
  • 17% of patients discontinued the NINLARO + Rd regimen because of AEs vs 14% for placebo + Rd1

The majority of AEs were first experienced within 6 months of initiating treatment and were manageable with supportive care5

The efficacy and tolerablility profile of the all-oral NINLARO + Rd regimen allowed patients' global quality of life to be sustained6

Adding oral NINLARO to Rd delivered a clinically meaningful PFS extension without negatively impacting global quality of life compared to placebo + Rd6

  • The double‑blind study design adds to the clinical significance of the quality of life assessment

Adding oral NINLARO to Rd delivered a clinically meaningful PFS extension without negatively impacting global quality of life compared to placebo + Rd6

Adapted from Supplementary Appendix to Moreau et al. 20166

Quality of life as assessed by EORTC QLQ-C30 and MY-20 questionnaires. Higher scores indicate better quality of life.