Bristol Myers nabs new FDA nod as Breyanzi brings CAR-T class to chronic lymphocytic leukemia

Cell TherapyImmunotherapyDrug ApprovalAccelerated ApprovalClinical Result
Bristol Myers nabs new FDA nod as Breyanzi brings CAR-T class to chronic lymphocytic leukemia
Source: FiercePharma
The unique chronic lymphocytic leukemia label gives Breyanzi one leg up against Gilead’s CD19 CAR-T leader, Yescarta.
Just as BeiGene’s Brukinsa encroaches on CAR-T territory, Bristol Myers Squibb has brought its CAR-T therapy Breyanzi into a type of blood cancer that’s considered the BTK inhibitor class’s home turf.
Breyanzi on Thursday won an FDA accelerated approval for previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), BMS said. To be eligible for the CD19-targeted CAR-T med, a patient must have tried a BTK drug such as Brukinsa and a BCL2 inhibitorBCL2 inhibitor such as AbbVie and Roche’s Venclexta.
Breyanzi is the first CAR-T cell therapy to enter the CLL/SLL field, where BTK inhibitorsBTK inhibitors are standard first-line treatments.
When the FDA accepted BMS’ application in November, there was no standard treatment for CLL/SLL patients who have failed on BTK and BCL2 inhibitors. But the situation has since changed, leaving Breyanzi with at least one competitor in the late-line setting.
In December, the FDA cleared Eli Lilly’s oral non-covalent BTK inhibitor JaypircaBTK inhibitor Jaypirca in the same post-BTK and -BCL-2 CLL/SLL setting. In the single-arm BRUIN trial, Jaypirca shrank tumors in 72% of patients previously treated with both a BTK and a BCL-2 inhibitorBCL-2 inhibitor, with the duration of response lasting for a median of 12.2 months. All the responses recorded were partial responses.
By comparison, Breyanzi in its own trial demonstrated an overall response rate of 45% among 65 patients who received the CAR-T therapy, according to its updated label. Although the number appears smaller than Jaypirca’s by cross-trial comparison, Breyanzi’s responses included 20% complete responses. In addition, the one-time CAR-T therapy’s median duration of response was also much longer, reaching 35.3 months.
“If we look at it, the response rate, the complete response rate and most importantly, the durability of those responses, it’s truly a paradigm shift,” BMS’ chief medical officer, Samit Hirawat, M.D., said of Breyanzi’s data in an interview with Fierce Pharma.
Hirawat believes Breyanzi’s single infusion, its durable anti-tumor effect and an established safety profile makes it a solid option in third-line CLL/SLL. But he also acknowledged that Breyanzi, like all other CAR-T therapies, is only administered at designated treatment centers, and therefore its accessibility should be factored into treatment decision-making.
Beyond that, “the objective from a patient perspective and a physician perspective is always to give the best therapy as soon as possible and have the best outcome for a patient without having to have a chronically delivered medicine,” Hirawat said.
As is the case with Jarypirca, Breyanzi was greenlit with an accelerated approval. BMS has agreed with the FDA to run a separate study in the same third-line setting to confirm Breyanzi’s clinical benefits. The open-label trial will have more patients with a longer-term follow-up of about 15 months post-response, according to Hirawat.
Breyanzi’s sales have been on the uptick, reaching $303 million last year, thanks to a 2022 approval in second-line large B-cell lymphoma. But it still lags behind Gilead SciencesCD19 rival, Yescarta, which collected $1.5 billion in 2023 sales.
BMS is also awaiting two FDA decisions for Breyanzi in follicular lymphoma and mantle cell lymphoma. The unique CLL/SLL label now gives Breyanzi one leg up against Gilead’s CD19 CAR-T leader.
Many cell therapy developers, including BMS, have lately developed an interest in autoimmune diseases. BMS has incorporated Breyanzi’s construct into an autoimmune candidate dubbed CD19 NEX T. Initial phase 1 data for the drug in systemic lupus erythematosus are expected this year.
“We’re looking forward to changing [these patients’] life from a quality-of-life perspective, as well as how those comorbidities can be reversed and be impacted,” Hirawat said.
He argued that Breyanzi’s safety profile, if replicated in CD19 NEX T, would be acceptable, given its generally low-grade cytokine release syndrome events and neurological toxicities.
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