Bristol-Myers Squibb and AbbVie’s Empliciti hasn’t picked up an indication since its initial multiple myeloma approval back in 2015. But with impressive new survival data in hand, the partners could be on their way to changing that.
Sunday, the partners rolled out data from a phase 2 study showing that the drug, in combination with Celgene’s Pomalyst and dexamethasone, could cut the risk of myeloma progression by 46% in previously treated myeloma patients, compared with Pomalyst and dexamethasone (Pd) on their own.
The Empliciti cocktail, known as EPd for short, kept disease at bay for a median 10.3 months, versus just 4.7 months for the Pd duo. And twice as many patients responded to the three-drug regimen, the drugmakers said.
Now, Bristol-Myers and AbbVie will take the results to health authorities in search of a new Empliciti use. Right now, the drug is approved alongside Celgene’s Revlimid and dexamethasone for patients who have already received anywhere from one to three prior treatments.
“These data support the hypothesis” that adding Empliciti to the mix “elicits a synergistic effect and prolongs, significantly, the progression-free survival of heavily pretreated patients with myeloma, regardless of the number of prior therapies,” Meletios Dimopoulos, M.D., professor and chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine, said in a statement.
“We believe that EPd, if approved by regulatory authorities, could become an important potential treatment option for patients with relapsed/refractory multiple myeloma whose disease has progressed after treatment with lenalidomide and a proteasome inhibitor,” he added.
Empliciti won its FDA nod in a busy period for multiple myeloma drugmakers, with late 2015 also featuring nods for Johnson & Johnson’s Darzalex and Takeda’s Ninlaro. Since then, though, Darzalex has gone on to move earlier and earlier into myeloma therapy—in May, it became the first-ever monoclonal antibody to score an approval in newly diagnosed patients—and ring up major sales.
Bristol-Myers, meanwhile, reaped just $231 million from Empliciti last year after taking in $150 million in 2016, the drug’s first year on the market. It paid 30% of the drug’s U.S. haul to AbbVie under the pair’s agreement, as well as royalties on sales outside the country.