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CLAIM #37078 · Eli Lilly and Company (LLY) · 2025Q4 earnings call · Feb 4, 2026 · due Dec 31, 2026

Later this year, we expect results from an additional phase three pirtobrutinib trial, Bruin CLL322.

Dr. Dan Skovronsky · Chief Scientific and Product Officer

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versus commitment · official band 5 percent
Committed
we expect results from an additional phase three pirtobrutinib trial, Bruin CLL322
Reported
we plan to submit the results of BRUIN CLL-322 to regulators later this year

How to check this claim

Look at: Announcement or disclosure of results (topline or detailed) from the BRUIN CLL-322 Phase 3 trial

It came true if: Company or trial sponsor publicly discloses BRUIN CLL-322 results (e.g., via press release, conference presentation, or publication) on or before 2026-12-31

Where: Company press releases, investor/earnings calls, clinicaltrials.gov (NCT for BRUIN CLL-322), medical conference presentations (e.g., ASH, ASCO)

In context

y, shown on the right side of slide 15, Bruin CLL314, pirtobrutinib was compared to a covalent BTK inhibitor, ibrutinib, in treatment-naive or BTK inhibitor-naive patients. The study met the primary endpoint of non-inferiority of overall response rate. And while progression-free survival data were immature, they trended in favor of pirtobrutinib. Notably, in the early analysis of the treatment-naive subpopulation, as shown here, pirtobrutinib reduced the risk of progression or death by 76% compared to ibrutinib. Both datasets were presented at the American Society of Hematology Annual Meeting and were simultaneously published in the Journal of Clinical Oncology. We submitted these results to regulatory authorities to potentially enable the use of pirtobrutinib in earlier lines of therapy. Later this year, we expect results from an additional phase three pirtobrutinib trial, Bruin CLL322. This trial evaluates pirtobrutinib in addition to a fixed-duration regimen of venetoclax and rituximab in previously treated CLL, SLL patients. If successful, this could form the basis for an additional regulatory submission later this year. We also presented updated combination data of Imlunestrant with Abemaciclib in metastatic breast cancer, which showed additional benefit compared to Imlunestrant alone. We submitted these data to regulators and are seeking to expand the Imlunestrant label. While we're encouraged by these new data for patients with metastatic breast cancer, we're even more excited about the opportunity for Imlunestrant in adjuvant breast cancer. Our ongoing 8,000-patient adjuvant breast cancer trial, EMBER-4, is fully enrolled and will be the next phase three readout o

Verify independently

SEC filings for LLY · Claim quote is verbatim from the 2025Q4 earnings call.