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. “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.