ASH: Takeda maintenance data set up Ninlaro for new myeloma nod

Takeda HQ
Takeda is looking for a Ninlaro indication in the maintenance setting, where Velcade is approved but has never been specifically tested. (Takeda)

SAN DIEGO—Takeda’s Ninlaro has watched from the sidelines as competing multiple myeloma drugs jumped into additional indications. But now it may finally be ready to do the same.

Sunday at the American Society of Hematology annual meeting, the Japanese drugmaker unveiled data showing Ninlaro could cut the risk of disease progression or death by 28% compared to placebo in adult patients who’ve already been treated with high-dose chemo and undergone an autologous stem cell transplant. Ninlaro kept myeloma at bay for a median 26.5 months, compared with 21.3 months for placebo.

RELATED: Takeda CEO says new myeloma drug Ninlaro will be 'significantly bigger than Velcade'

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If Ninlaro can ultimately snag an FDA go-ahead based on the data, just under 8,000 new U.S. patients per year could be eligible for treatment, Jay Humphrey, Takeda’s VP of U.S. marketing, estimated—though only three-quarters of eligible patients now receive a maintenance therapy in the real world. Currently, Ninlaro is cleared in combination with Celgene's Revlimid and dexamethasone for use in patients who have relapsed after one or more prior myeloma treatments. 

The trial, dubbed Tourmaline-MM3, marks “the first time we’ve really been able to isolate in a definitive way what a proteasome inhibitor can do in the maintenance setting,” Humphrey said. Although Ninlaro’s blockbuster predecessor Velcade bears a broad label that allows for maintenance use, its potential side effects kept Takeda from ever specifically testing it in the maintenance setting.

Not Ninlaro, though. In the MM3 study, only 7% of patients discontinued treatment because of adverse events, compared with 5% in the placebo arm.

RELATED: Johnson & Johnson's Darzalex snags landmark myeloma approval in first-line patients

Those low toxicity levels will be important for Ninlaro going forward, particularly as it seeks to enter the front-line setting—where Johnson & Johnson’s CD38 drug Darzalex, which arrived on the scene in late 2015 as Ninlaro did, already bears an FDA green light.

The low toxicity profile may make Ninlaro “a very good combination partner with other classes,” inclusive of CD38, Humphrey said, adding, “I do think we can sustain that treatment duration differently than what we’ve been able to do with Velcade.”

In the meantime, though, Takeda isn’t going for a continuous use indication. There’s “not a global consistent view of what’s the ideal treatment duration of maintenance therapy,” but in the MM3 study, the company capped treatment at 24 months, Humphrey said.

That ceiling “allows us to be able to speak to payers with more certainty in regard to the budget impact type of considerations that they’ll be weighing as they asses this as a treatment option in their respective geographies,” he added.