Ninlaro Maintenance Therapy Fares Well in Phase 3 Multiple Myeloma Trial

Takeda‘s proteasome inhibitor Ninlaro (ixazomib) prevents multiple myeloma from progressing or returning when given as a maintenance therapy to patients who responded to first-line therapy and stem cell transplant, a Phase 3 clinical trial shows.

The trial, called TOURMALINE-MM3 (NCT02181413), compared Ninlaro to placebo in newly-diagnosed patients given standard induction therapy — regimens containing either a proteasome inhibitor, an immunomodulating drug, or both — followed by high-dose chemotherapy and an autologous stem cell transplant. (Proteasome inhibitors are drugs that block the function of proteasomes, which are cellular complexes that break down proteins.)

To be eligible for this trial, participants should have achieved a complete response, a very good partial response, or a partial response to the treatment. Of note, an autologous stem cell transplant is one made with a patient’s own stem cells, which are collected prior to aggressive treatments and given afterward.

“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,” he added.

TOURMALINE-MM3 included 656 myeloma patients, who were randomly assigned Ninlaro or a placebo after responding to high-dose therapy and stem cell transplant. Treatment was given orally, once a week, in a three-weeks-on, one-week-off regimen, for up to two years.

In addition to the primary goal of progression-free survival, which was already met, researchers also will examine if Ninlaro improves patient’s overall survival, time to disease progression, time to start a new line of therapy, safety, and quality of life, among others.

Results will be presented in December at the  60^th American Society of Hematology (ASH) Annual Meeting & Exposition, in San Diego, California.

Meanwhile, Takeda is planning to submit the data to regulatory authorities, requesting the approval of Ninlaro as a maintenance therapy for multiple myeloma patients who responded to high-dose therapy and stem cell transplant.

“Within the maintenance setting, it is critical that we find agents that are efficacious, tolerable and convenient,” Jesús Gomez Navarro, MD, said in a press release. Navarro is vice president, head of oncology clinical research and development, at Takeda.

Ninlaro is approved in the U.S. and Europe in combination with Revlimid (lenalidomide) and dexamethasone for adult multiple myeloma patients who received at least one prior treatment.

Ninlaro’s clinical program includes four additional myeloma trials, two of which are still recruiting participants. The TOURMALINE-MM4 Phase 3 study (NCT02312258) is testing Ninlaro as a maintenance treatment in patients who responded to first-line therapy, but did not receive a stem cell transplant.

The TOURMALINE-MM5 Phase 3 trial (NCT03170882) is assessing if Ninlaro is better than Pomalyst (pomalidomide) at delaying disease progression or death in patients who failed prior Revlimid therapy