by Dr. C.H. Weaver M. D. 12/2018
Ninlaro (ixazomib) delays cancer progression when used as maintenance therapy following autologous stem cell transplantation (ASCT) and represents a new treatment option according to results from the TOURMALINE-MM3 clinical trial. (1)
The use of maintenance therapy post ASCT treatment for multiple myeloma is currently a standard of care because it improves survival and is typically accomplished with the drug Revlimed (lenalidomide). Nearly one-third of patients will ultimately discontinue Revlimed due to side effects however and Ninlaro which is taken orally and has requires less-frequent administration could be beneficial for individuals who can’t tolerate Revlimd therapy. (2)
Ninlaro is referred to as a proteasome inhibitor. It produces anti-cancer effects by blocking proteins called enzymes within myeloma cells. By blocking these enzymes, the growth of the cancer cells is reduced or halted. The United States Food and Drug Administration (FDA) has granted approval to Ninlaro® for the treatment of multiple myeloma.
The TOURMALINE-MM3 clinical trial evaluated 656 adult patients with newly diagnosed multiple myeloma who had responded to induction therapy prior to undergoing high dose chemotherapy and stem cell transplant. Patients were treated with either weekly Ninlaro or matched placebo and directly compared.
The study found that Ninlaro treated patients experienced a 28 percent lower risk of disease progression compared with placebo and a higher rate of conversion from MRD-positive to MRD-negative status. Whether or not Ninlaro prolongs survival has yet to be determined and requires longer follow up.
Dimopoulos MA, Gay F, Schjesvold FH, et al. Maintenance therapy with the oral proteasome inhibitor (PI) ixazomib significantly prolongs progression-free survival (PFS) following autologous stem cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma (NDMM): phase 3 Tourmaline-MM3 trial. Abstract #301. Presented at the 2018 ASH Annual Meeting, December 2, 2018; San Diego, CA.