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TOLERABILITY

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.