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
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
- 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 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
AEs of special interest: no safety concerns identified (≤2% difference between oral NINLARO + Rd and placebo + Rd)1
* Represents multiple MedDRA preferred terms
† Includes treatment-emergent AEs and new primary maligancies reported during follow-up period
Oral NINLARO is available in several strengths to allow for dose modifications
- 4 mg is the usual recommended starting dose
- Use the recommended starting dose of 3 mg in patients with moderate or severe haptic impairment, severe renal impairment or end-stage renal disease requiring dialysis1
- No dose adjustment is required for:1
- Body type or weight
- Elderly patients older than 65 years
- Patients with mild or moderate renal impairment *
- Patients with mild hepatic impairment +
- Moreau P, Masszi T, Grzasko N. N Engl J Med. 2016;374:1621-34.
- NINLARO (ixazomib capsules) Summary of Product Characteristics.
- Takeda Data on File - UK/DF/1611/0017.
- Takeda Data on File - UK/DF/1701/0002.
- Takeda Data on File - UK/DF/1611/0018.
- Moreau P, Masszi T, Grzasko N. N Engl J Med. 2016;374:1621-34, Supplemental Appendix. Available at http://www.nejm.org/doi/suppl/10.1056/NEJMoa1516282/suppl_file/nejmoa1516282_appendix.pdf. Accessed January 2017.
- Mateos M-V, Masszi T, Grzasko N, et al. Haematologica. 2017; epub ahead of print.
- Takeda Data on File - UK/DF/1708/0010.