Liso-cel safety data bodes well as BMS tackles CAR-T headwinds

Concerns about CAR-T safety continue to be a challenge for the sector according to Bristol-Myers Squibb, which outlined plans to address such “headwinds” during a Q4 call.

Bristol Myers Squibb (BMS) spoke about the chimeric antigen receptor (CAR) T-cells sector last week, explaining while the market for such therapies is expanding, growth rates are not as fast as they could be.

Nadim Ahmed, president of BMS hematology department, told analysts: “Clearly, there have been some headwinds in the [CAR-T] marketplace and I think about things like reimbursement access environment complexity of manufacturing.”

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Safety concerns associated with such therapies are also a factor according to Ahmed, who said “the safety profile of current agents has led to most of the administration being conducted in the inpatient setting.”

He also outlined BMS’ plan to tackle the “near-term headwinds” impacting the firm’s CAR-T business, citing the candidate cancer therapy lisocabtagene maraleucel (liso-cel) as an example.

“We are seeing a safety profile where significant reduction in the incidence and severity of CRS [cytokine release syndrome] neurotoxicity, which we think bodes well to be able to give this treatment in the outpatient setting.”

The ability to administer CAR-T therapies in an outpatient setting should expand usage according to Ahmed, who also said BMS’ relationships with hematologists will also help.

“Our footprint out in the community will really help us to drive those referrals into the treatment sites where CAR Ts will be given as well as expand out into the community with assets like liso-cel.”

The comments follow just months after BMS filed a Biologics License Application (BLA) for liso-cel with the US FDA.

Financials

BMS saw fourth-quarter revenues of $7.9 billion, up 33% from the equivalent period last year. For the full year revenue was $26.1 billion, which is an increase of 16% on 2018.

BMS reported a net loss of $1.1 billion for the final three months of 2019, down from net earnings of $1.2 billion in Q4 of 2018.

The firm attributed the deficit to costs associated with its $74 billion acquisition of Celgene, which completed last November.

In January, BMS completed the divestiture of its oral solid, biologics and sterile product manufacturing and packaging facility in Anagni, Italy, to Catalent.