Bristol Myers claims win with CAR-T therapy Breyanzi in leukemia
Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.
The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.
The overall trial was a Phase I/II, open-label and single-arm study in patients with both relapsed or refractory CLL or SLL. While complete specifics regarding the trial have not been made public yet, Bristol Myers said in a statement that the pharma will evaluate the data and work with investigators to present results at a future medical meeting, as well as discuss said results with certain health authorities.
A Bristol Myers spokesperson told Endpoints News that the Phase II portion of the trial tested Breyanzi at a dose of 100 million T-cells based off results from the Phase I monotherapy arm.
The therapy, acquired by Bristol Myers when it bought out Celgene for $74 billion in 2019, was first approved back in 2021 for pre-treated diffuse large B cell lymphoma, with expansions since then into more lymphoma indications. And while a spokesperson told Endpoints that the Big Pharma is pursuing opportunities to expand Breyanzi even more, Bristol Myers’ head of cell therapy development Anne Kerber said in the trial announcement Thursday that with CLL’s “complex biology and immune dysregulation,” the currently incurable disease makes developing T cell-based therapies for CLL “very challenging.”
Any potential approval for Breyanzi in CLL would mean immediate competition against the likes of AbbVie and Johnson & Johnson’s BTK inhibitor Imbruvica. The FDA just expanded the potential therapies available for the disease after giving the thumbs-up to BeiGene’s Brukinsa last week, after BeiGene showed at ASH last year the oral therapy beat then-standard-of-care Imbruvica in a head-to-head test.