Eli Lilly's Leukemia Drug Matches Johnson & Johnson's Imbruvica In Untreated Patients

Benzinga · 2d ago

On Sunday, Eli Lilly and Co. (NYSE:LLY) shared results from the Phase 3 BRUIN CLL-314 trial of Jaypirca (pirtobrutinib) versus Imbruvica (ibrutinib) in chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who were treatment-naïve or were BTK inhibitor-naïve.

Johnson & Johnson’s (NYSE:LLY) Imbruvica is a covalent BTK inhibitor.

Pirtobrutinib met its primary endpoint of non-inferiority on overall response rate (ORR) compared to ibrutinib (87.0% versus 78.5%) in the intent-to-treat (ITT) population.

Pirtobrutinib also had numerically higher ORR rates, and, while immature, progression-free survival (PFS) was also trending in favor of pirtobrutinib compared to ibrutinib across all populations, including a 76% reduction in the risk of disease progression or death in treatment-naïve patients, the subgroup with the longest follow-up.

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PFS, a key secondary endpoint, was not yet mature at this analysis but was trending in favor of pirtobrutinib compared to ibrutinib in the ITT relapsed/refractory and treatment-naïve populations, with a median follow-up of 22.0 months, 18.4 months, and 22.5 months, respectively.

Among all subgroups, the largest PFS effect size was observed in the treatment-naïve subgroup, which had the longest follow-up at this data cut, with a 76% reduction in the risk of disease progression or death.

The data were highlighted at the American Society of Hematology (ASH) Annual Meeting and Exposition, and simultaneously published in the Journal of Clinical Oncology

The overall safety profile for patients treated with pirtobrutinib in BRUIN CLL-314 was similar to previously reported trials, and the most common treatment-emergent adverse events were similar between arms.

LLY Price Action: Eli Lilly shares were down 1.54% at $994.79 at the time of publication on Monday, according to Benzinga Pro data.

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