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Takeda’s Ninlaro swings and misses in newly diagnosed myeloma

March 10, 2020 Carly Helfand


Just one day after Bristol Myers Squibb said its Empliciti had failed a multiple myeloma trial that could have widened its market, Takeda revealed Ninlaro had suffered the exact same fate.

In a study of previously untreated patients ineligible for stem cell transplant, adding Ninlaro to a combination of Celgene’s Revlimid and steroid dexamethasone didn’t significantly lengthen the period of time before disease worsened.

The three-drug cocktail kept myeloma at bay for a median 35.3 months, versus 21.8 months for the Revlimid-dexamethasone combination, known as Rd. But that 13.5 month-benefit didn’t meet the statistical significance threshold, Takeda said Tuesday.

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RELATED: BMS’ Empliciti misses shot at new myeloma market with phase 3 failure

It’s a blow for Takeda, which was looking to follow Johnson & Johnson’s Darzalex into the more lucrative first-line setting, where there are more patients who tend to stay on therapy for longer. That drug racked up an OK alongside Rd last June, marking its second FDA approval in newly diagnosed patients.

And while Darzalex and Ninlaro won their first approvals the same month, the J&J product is light-years ahead in terms of sales. In Takeda’s 2019 fiscal year, Ninlaro generated 62.2 billion yen ($597.9 million)—far below the $3 billion Darzalex amassed last year.

Failure to expand outside myeloma hasn’t helped Ninlaro’s cause, either. Last June, Takeda scrapped a phase 3 trial in systemic light-chain amyloidosis where Ninlaro wasn’t hitting its marks. That failure followed a move by the company a few months prior to withdraw an FDA application in myeloma to await more survival data.

RELATED: Takeda scores a win for Ninlaro as it aims to pioneer ‘switch’ maintenance in multiple myeloma

It hasn’t been all bad news for Ninlaro, though. In November, the Japanese drugmaker said the drug had scored a phase 3 win over placebo in patients who had not undergone stem cell transplants and were taking Ninlaro as a first-line maintenance treatment.

Meanwhile, Monday, BMS said a trio of Empliciti and Rd had failed to outdo Rd alone in the progression-free survival department, recording a flop in the same patient population where Ninlaro posted its latest stumble.



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