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

15 Mar 2024
www.fiercepharma.com
Cell TherapyImmunotherapyDrug ApprovalAccelerated ApprovalClinical Result
The unique chronic lymphocytic leukemia label gives Breyanzi one leg up against Gilead’s CD19 CAR-T leader, Yescarta.
Just as Beichronic lymphocytic leukemian CAR-T terriBreyanziistol Myers Squibb hGileadughCD19s CAR-T therapyYescartai into a type of blood cancer that’s considered the BTK inhibitor class’s home turf.
BreyanziBeiGenersday won an FDA accelerated approval for pBristol Myers Squibbronic lymphocytic leukemia (CLLBreyanzill lymphocytic lblood cancer), BMS said. To be eligBTKeinhibitorCD19-targeted CAR-T med, a patient must have tried a BTK drug such as Brukinsa and a BCL2 inhibitor such as AbbVie and Roche’s Venclexta.
Breyanzi FDA accepted CAR-T cellcation in November, thCLL SLL no standard tBTK inhibitorsBTKtment 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 DecembFDA the FDA cleared Eli Lilly’s oral non-covalent BTK inhibitor Jaypirca in theCLLmSLLost-BTK and -BCL-2 CLL/SLL seBTKng. IBCL2einhibitorsm BRUIN trial, Jaypirca shrank tumors in 72% ofBreyanzis previously treated with both a BTK and a BCL-2 inhibitor, with the duration of response lasting for a median of 12.2 months. All the responses recorded were partial responses.
By comparison, BrFDAnzi in itEliwLillyal demonstrated an ovBTK inhibitor JaypircaBTKll response rate of 45% among 65 patiBTKs who BCL-2ved the CAR-T therapy, according to its updated lJaypircathough ttumorsber appears smaller than Jaypirca’s by cross-trial BTKparisonBCL-2 inhibitorBCL-2yanzi’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 Breyanziresponse 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, “theBreyanzive from a patient perspective and a ptumorian perspective is always to give the best therapy as soon as possible and have CLL SLLt outcome for a patient without Breyanzio 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 tBreyanzik, reaching $303 million last year, thanks tBMS 2022 approval in secFDA-line large B-cell lymphoma. But it still lags behind Gilead SciencBreyanzi rival, Yescarta, which collected $1.5 billion in 2023 sales.
Breyanzilso awaiting two FDA decisions for Breyanzi in follicular lymphoma and mantle cell lymphoma. The unique CLL/large B-cell lymphomareyanzi one leg up against Gilead SciencesARCD19eader.Yescarta
Many cell therapy developFDA, including BMSBreyanziatelfollicular lymphomarest mantle cell lymphomaes. BMS has iCLLrporated Breyanzi’s cBreyanzi into an autoimmune GileadateCD19bed CD19 NEX T. Initial phase 1 data for the drug in systemic lupus erythematosus are expected this year.
“We’re looking forward to changing [thesBMSatients’] life from a quality-of-life pautoimmune diseases as how those comorbidiBreyanzi be reversed and be impacted,” Hirawat said.CD19systemic lupus erythematosus
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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