Ninlaro maintenance therapy extends PFS in posttransplant myeloma

Maintenance therapy with ixazomib significantly extended PFS compared with placebo for certain patients with myeloma, according to the agent’s manufacturer.

Ixazomib (Ninlaro, Takeda), an oral proteasome inhibitor, is approved for use in combination with lenalidomide (Revlimid, Celgene) and dexamethasone for patients with multiple myeloma who received at least one prior treatment. The agent — which is not approved as maintenance therapy for myeloma after autologous stem cell transplant — remains under investigation for a variety of myeloma treatment settings, as well as for systemic light-chain amyloidosis.

The randomized phase 3 TOURMALINE-MM3 trial evaluated the effect of ixazomib as single-agent maintenance therapy for adults with myeloma who responded to induction therapy followed by high-dose therapy and autologous stem cell transplant.

The double-blind, placebo-controlled trial included 656 patients who received single-agent ixazomib or placebo.

The study met its primary endpoint, as ixazomib significantly extended PFS compared with placebo.

Ixazomib’s safety profile in TOURMALINE-MM3 appeared consistent with prior reports of the agent as monotherapy. No new safety signals emerged.

Takeda officials intend to submit the data for presentation at ASH Annual Meeting and Exposition later this year. They also will submit trial data to regulatory agencies..

“Within the maintenance setting, it is critical that we find agents that are efficacious, tolerable and convenient,” Jesús Gomez Navarro, MD, vice president and head of oncology clinical research and development for Takeda, said in a company-issued press release. “The results of the TOURMALINE-MM3 trial represent an important step toward the goal of expanding the use of Ninlaro as a maintenance therapy. This is the first and only phase 3 placebo-controlled study evaluating a proteasome inhibitor in this setting, and we look forward to discussions with health authorities around the world.”

Maintenance therapy with ixazomib significantly extended PFS compared with placebo for certain patients with myeloma, according to the agent’s manufacturer.

Ixazomib (Ninlaro, Takeda), an oral proteasome inhibitor, is approved for use in combination with lenalidomide (Revlimid, Celgene) and dexamethasone for patients with multiple myeloma who received at least one prior treatment. The agent — which is not approved as maintenance therapy for myeloma after autologous stem cell transplant — remains under investigation for a variety of myeloma treatment settings, as well as for systemic light-chain amyloidosis.

The randomized phase 3 TOURMALINE-MM3 trial evaluated the effect of ixazomib as single-agent maintenance therapy for adults with myeloma who responded to induction therapy followed by high-dose therapy and autologous stem cell transplant.

The double-blind, placebo-controlled trial included 656 patients who received single-agent ixazomib or placebo.

The study met its primary endpoint, as ixazomib significantly extended PFS compared with placebo.

Ixazomib’s safety profile in TOURMALINE-MM3 appeared consistent with prior reports of the agent as monotherapy. No new safety signals emerged.

Takeda officials intend to submit the data for presentation at ASH Annual Meeting and Exposition later this year. They also will submit trial data to regulatory agencies..

“Within the maintenance setting, it is critical that we find agents that are efficacious, tolerable and convenient,” Jesús Gomez Navarro, MD, vice president and head of oncology clinical research and development for Takeda, said in a company-issued press release. “The results of the TOURMALINE-MM3 trial represent an important step toward the goal of expanding the use of Ninlaro as a maintenance therapy. This is the first and only phase 3 placebo-controlled study evaluating a proteasome inhibitor in this setting, and we look forward to discussions with health authorities around the world.”