LLY's Phase III Study on Jaypirca in Front-Line Leukemia Meets Goal

Eli Lilly LLY announced that the phase III BRUIN CLL-313 study, evaluating its BTK inhibitor Jaypirca (pirtobrutinib) versus chemoimmunotherapy (bendamustine plus rituximab) in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions, has met its primary endpoint.

Data from the study showed that treatment with Jaypirca led to a highly statistically significant and clinically meaningful improvement in progression-free survival versus chemoimmunotherapy, as assessed by an independent review committee in the given patient population. Per the company, the data indicate one of the strongest effect sizes seen with a single-agent BTK inhibitor in a front-line CLL study.

Meanwhile, overall survival (OS), a key secondary endpoint, was immature at this analysis but showed a strong trend favoring Jaypirca. Statistical significance will be assessed in the primary OS analysis, which is expected in 2026.

The overall safety profile of Jaypirca was similar to that seen in previously reported studies across treatment settings. Detailed results will be shared later this year.

Jaypirca is already approved for the treatment of adult patients suffering from relapsed or refractory mantle cell lymphoma (“MCL”) who have received at least two lines of systemic therapy, including a BTK inhibitor. The drug is also approved in the United States for treating CLL/SLL in patients who have received a minimum of two lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

LLY's Price Performance

Year to date, shares of Lilly have declined 4.6% compared with the industry’s decrease of 0.7%.

LLY's Ongoing Development Activities With Jaypirca

The BRUIN CLL-313 study is the third phase III study, which highlights the potential of Jaypirca to be a meaningful treatment option for people with untreated CLL/SLL.

Lilly recently announced top-line data from the phase III BRUIN CLL-314 head-to-head study, which compared Jaypirca to AbbVie ABBV and J&J’s JNJ Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with CLL/SLL. The study met the primary endpoint by showing non-inferiority of Jaypirca in overall response rate (ORR), with results favoring Jaypirca and a nominal P-value for superiority under 0.05.

Management plans to use the data from the BRUIN CLL-313 and BRUIN CLL-314 studies to support global regulatory submissions for use in earlier lines of Jaypirca in CLL/SLL later in 2025.

Jaypirca is one of Lilly’s several new drugs that have made a meaningful contribution to the company’s top-line growth. During the first half of 2025, Jaypirca recorded sales worth $215.3 million. A potential label expansion in earlier lines of therapy to enable broader use for the approved indications of CLL and MCL should boost sales further.

LLY's Competition in the Targeted Space

Some BTK inhibitors available in the market for CLL are AbbVie and J&J’s Imbruvica and AstraZeneca’s AZN Calquence. In the last few quarters, sales of AbbVie and JNJ’s Imbruvica have been declining steadily amid rising competition from AstraZeneca’s Calquence and other novel oral treatments, all of which are approved by the FDA to treat similar indications.

LLY's Zacks Rank

Eli Lilly currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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