Eli Lilly and Company
Pharmaceutical company with gene therapy licensing deal with REGENXBIO
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Key metrics · each point sourced
Stated objectives
Obtain U.S. regulatory approval for Inluriyo in combination with abemaciclib for ESR1-mutated MBC
sourceAdvance LY4064809/STX-478 from Phase 1/2 to Phase 3 trial for PIK3CA-mutant HR+, HER2- advanced breast cancer
sourceDemonstrate overall survival benefit, progression-free survival, and time to chemotherapy improvements in EMBER-3 trial for ESR1-mutated breast cancer
sourceShow sustained IDFS/DRFS improvements and OS prolongation in monarchE trial across nodal status subgroups
sourceTranslate biologic conviction into meaningful progress by addressing the three most important biologic targets in HR+ breast cancer: CDK4/6, the estrogen receptor, and PI3K
sourceDemonstrate non-inferiority of pirtobrutinib versus ibrutinib on overall response rate in CLL/SLL patients
sourceComplete formal PFS analysis testing for superiority of pirtobrutinib
sourceVerify and describe clinical benefit of Jaypirca in confirmatory trials to maintain accelerated approval status
sourceDemonstrate pirtobrutinib's potential role across treatment settings and B-cell malignancies through development program
sourceReceive regulatory approvals for pirtobrutinib in earlier disease settings to expand treatment options for patients
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