BMS' Empliciti misses shot at new myeloma market with phase 3 failure

Bristol-Myers Squibb
Adding Empliciti to the mix didn't improve results for BMS' Revlimid-dexamethasone combo. (Bristol Myers Squibb)

Bristol Myers Squibb and AbbVie’s Empliciti debuted the same month as Johnson & Johnson’s Darzalex, but it so far hasn’t been able to follow the J&J drug to stardom. Its latest hurdle? A flopped phase 3 trial in newly diagnosed patients.

Adding Empliciti to a combination of Celgene’s Revlimid and steroid dexamethasone, a regimen known as Rd, didn’t significantly stave off disease progression compared with Rd alone in patients ineligible for stem cell transplant, BMS said Monday. The New Jersey drugmaker, which handles all marketing for the drug, will share further details at a future medical meeting.

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Like other drugs, including Amgen’s Kyprolis, Empliciti is already approved alongside Rd in relapsed or refractory patients. But previously untreated patients represent the largest myeloma market, as they make up a larger group that tends to stay on therapy for longer.

Just look at Johnson & Johnson’s Darzalex, which has dominated the myeloma landscape recently with two front-line OKs—including one in combination with Rd. Its global sales jumped to $3 billion in 2019, up from $1.24 billion in 2017, when the drug was still relegated to later lines of therapy.

Empliciti, meanwhile, recorded just a fraction of those sales last year, checking in with $357 million.

Luckily for Bristol, it recently came into ownership of Revlimid via its Celgene buyout, and it’s planning to lean on the myeloma specialist’s commercial expertise to boost sales of its own legacy meds.

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“The advantage ... we’ve had at legacy Celgene is that we have a very robust infrastructure to support multiple myeloma, both from a sales and marketing perspective,” Nadim Ahmed, the combined company’s hematology president, said in a January interview.

Empliciti is “a very natural fit that just slides very easily into our commercial organization, so we’ve been able to do that without any disruption and with the right degree of focus also,” he added.