Lilly reports positive Phase 3 data for Jaypirca in CLL/SLL

Eli Lilly (NYSE:LLY) reported positive Phase 3 data from its BRUIN CLL-321 study of its drug pirtobrutunib, also known as Jaypirca, in the treatment adult patients with chronic lymphocytic leukemia, or CLL, or small lymphocytic lymphoma, or SLL, previously treated with a covalent BTK inhibitor.

The study met its primary endpoint of progression-free survival at primarily analysis, showing that pirtobrutinib was superior to idelalisib plus rituximab, also known as IdealR, or bendamustine plus rituximab, also known as BR, according to a statement.

Lilly (LLY) said the updated results demonstrate consistent improvement in progression-free survival for patients treated with pirtobrutinib, with a reduction in risk of relapse, disease or death by 46% compared to the IdelaR or BR combinations.

The data is expected to be presented at the 66th American Society of Hematology Annual Meeting, which is being held Dec. 7-10 in San Diego.

Jaypirca has received accelerated approval from the FDA for the treatment of adult patients with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and BCL-2 inhibitor and adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a BTK inhibitor.

Lilly (LLY) noted that Jaypirca’s continued approval for the indications may be contingent upon verification and description of clinical benefit in a confirmatory trial. The drug was first approved in 2023.