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 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 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
- 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 irrespective of patients' cytogenetic risk profile3
Oral NINLARO + Rd patients responded rapidly2
Oral NINLARO + Rd patients' responses deepened with sustained treatment4
- Moreau P, Masszi T, Grzasko N. N Engl J Med. 2016;374:1621-34.
- NINLARO (ixazomib capsules) Summary of Product Characteristics.
- Avet-Loiseau H, Bahlis N, Chng W-J, et al. Haematologica 2016;101(S1) Abstract p269.
- 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/1708/0009.