Eli Lilly and Co. (NYSE:LLY) shares were little changed in Monday’s premarket session.

The U.S. drug giant shared results from the Phase 3 BRUIN CLL-322 trial of Jaypirca (pirtobrutinib), which showed significant improvement in progression-free survival when combined with venetoclax and rituximab.

The trial included patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).

CLL/SLL is a type of blood cancer. Specifically, it is a cancer of a type of white blood cell called the B-lymphocyte.

AbbVie Inc. (NYSE:ABBV) sells venetoclax under the Venclexta name.

Eli Lilly Reports Strong Phase 3 Results

The BRUIN CLL-322 trial results mark the fourth positive Phase 3 study for pirtobrutinib, indicating its potential for label expansion later this year.

The trial demonstrated that the addition of pirtobrutinib led to a statistically significant improvement in progression-free survival, a key metric for treatment efficacy.

Overall survival (OS), a key secondary endpoint, was not yet mature at this analysis, but was trending in favor of the pirtobrutinib combination regimen.

Detailed results will be presented at a medical congress and submitted to a peer-reviewed journal.

Eli Lilly intends to submit these results to regulators later this year for a label expansion.

Head-To-Head Data Shows Competitive Positioning Against Imbruvica

Data from the Phase 3 BRUIN CLL-314 trial of Jaypirca (pirtobrutinib) versus Johnson & Johnson’s Imbruvica (ibrutinib) met its primary endpoint.

Showed 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, including a 76% reduction in the risk of disease progression or death in treatment-naïve patients, the subgroup with the longest follow-up.

Eli Lilly’s Phase 3 BRUIN CLL-313 trial of Jaypirca versus chemoimmunotherapy met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival.

Retevmo Trial Data Adds Momentum In Lung Cancer Segment

In February, Eli Lilly shared positive topline results from the Phase 3 LIBRETTO-432 clinical trial for Retevmo (selpercatinib).

The trial demonstrated a highly statistically significant improvement in event-free survival for patients with early-stage non-small cell lung cancer.

The LIBRETTO-432 trial results showed that selpercatinib significantly reduced the risk of disease recurrence or death in patients with RET fusion-positive non-small cell lung cancer.

LLY Stock Price Activity: Eli Lilly shares were down 0.01% at $939.36 during premarket trading on Monday, according to Benzinga Pro data.

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