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Lilly Presents Interim Data From Trial In B-Cell Leukemias And Lymphomas

Eli Lilly and Co. (LLY) announced interim clinical data from the LOXO-305 global Phase 1/2 BRUIN dose escalation trial. LOXO-305 is an investigational, highly selective, non-covalent Bruton's tyrosine kinase (BTK) inhibitor.

At all doses studied, LOXO-305 delivered objective responses in patients who had received diverse prior therapies and had exhibited varied molecular mechanisms of acquired resistance.

The BRUIN Phase 1/2 trial, which began enrolling patients in March 2019, contains a dose escalation phase and a dose expansion phase. The dose escalation phase follows a "3+3" design. LOXO-305 is dosed orally in 28-day cycles.

As dose cohorts are cleared, additional patients can enroll in cleared cohorts and intra-patient dose escalation is permitted. The primary endpoint of the trial is the determination of the maximum tolerated dose (MTD) or recommended dose for further study. Secondary endpoints include safety, overall response rate (by disease-specific criteria) and duration of response.

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