Lilly’s Jaypirca Beats Imbruvica in CLL Trial; Fulcrum Slides on Sickle-Cell Data

Eli Lilly said its non-covalent BTK inhibitor Jaypirca met the primary endpoint in the late-stage BRUIN CLL-314 trial, the first head-to-head study against Imbruvica to include treatment-naïve chronic lymphocytic leukemia or small lymphocytic lymphoma patients. The drug achieved non-inferiority—and a nominally significant favorability (p < 0.05) —on overall response rate, with immature but improving progression-free-survival data. Detailed results will be presented later this year and could support broader regulatory filings. Separately, Fulcrum Therapeutics reported Phase 1b results indicating its oral agent pociredir modestly boosted fetal hemoglobin in sickle-cell patients, suggesting a potential pill-based therapy for the inherited blood disorder. External specialists called the effect incremental and said larger studies are needed to confirm clinical benefit. Fulcrum disclosed the data alongside second-quarter earnings; its shares fell roughly 14% in pre-market trading.