Lilly's Jaypirca (pirtobrutinib) significantly extended progression-free survival when added to a venetoclax time-limited regimen in patients with previously treated CLL/SLL

Rhea-AI Summary

Lilly (NYSE: LLY) announced positive topline results from the Phase 3 BRUIN CLL-322 trial showing that adding Jaypirca (pirtobrutinib) to venetoclax plus rituximab produced a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in relapsed/refractory CLL/SLL.

Results were consistent across subgroups, including patients previously treated with covalent BTK inhibitors. Overall survival was immature but trended favorably. Safety was consistent with known profiles and discontinuation rates were low and similar between arms. Lilly plans regulatory submissions later in 2026.

Positive

• Primary endpoint met: statistically significant, clinically meaningful PFS improvement
• Efficacy consistent in patients previously treated with covalent BTK inhibitors
• Safety profile consistent with known profiles; low, similar discontinuation rates
• Lilly intends to pursue regulatory submissions for label expansion in 2026

Negative

• Overall survival not yet mature at this analysis
• Detailed efficacy and safety data pending presentation and peer review

News Market Reaction – LLY

-1.06%

-1.06% Session close to close

In the Apr 13 session, LLY declined 1.06%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlighted a statistically significant and clinically meaningful progression-free...

Analysis

This announcement highlighted a statistically significant and clinically meaningful progression-free survival benefit when Jaypirca was added to a time-limited venetoclax/rituximab regimen in previously treated CLL/SLL, marking the fourth positive Phase 3 readout for pirtobrutinib. Safety appeared consistent with known profiles and discontinuation rates were low. In the context of Lilly’s recent obesity, diabetes and dermatology successes, this reinforces its oncology pipeline depth. Investors may watch for full data presentations, regulatory submissions later this year, and any related label expansion decisions.

Key Figures

Treatment duration: Up to 2 years Positive Phase 3 trials: Fourth positive Phase 3 Phase designation: Phase 3 +5 more

8 metrics

Treatment duration Up to 2 years Therapy duration in both BRUIN CLL-322 study arms

Positive Phase 3 trials Fourth positive Phase 3 Pirtobrutinib in CLL across the BRUIN program

Phase designation Phase 3 BRUIN CLL-322 trial stage

Current share price $939.47 Pre-news trading level for LLY

52-week high $1,133.95 Upper end of LLY’s 52-week range

52-week low $623.78 Lower end of LLY’s 52-week range

Market cap $853,326,074,010 Pre-news equity value

2025 revenue $65.2 billion Reported in 2026 proxy statement

Historical Context

5 past events · Latest: Apr 09 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 09	Drug launch	Positive	+0.2%	Foundayo oral GLP-1 weight-loss pill became available in the U.S. market.
Apr 01	FDA approval	Positive	+3.8%	FDA approved Foundayo as a GLP-1 pill for obesity and overweight adults.
Mar 31	Acquisition deal	Positive	+3.7%	Agreement to acquire Centessa to expand into sleep-wake disorder treatments.
Mar 27	Clinical durability data	Positive	-2.1%	EBGLYSS Phase 3b data showed up to four years of durable AD disease control.
Mar 19	Clinical trial results	Positive	-0.1%	Retatrutide achieved significant A1C reductions and weight loss in Phase 3 diabetes trial.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent major clinical and product wins often saw positive or modestly positive price reactions, but there are instances where strong trial data coincided with flat or negative moves.

Recent Company History

Over the past month, Lilly has reported multiple high-impact developments across obesity, diabetes, dermatology and neuroscience. FDA approval and subsequent U.S. availability of Foundayo for weight loss on April 1 and April 9, 2026 saw modest to strong gains. The Centessa acquisition added a sleep-wake pipeline with a deal value up to about $7.8 billion, also met with a positive reaction. By contrast, robust Phase 3 data for EBGLYSS and retatrutide drew flat-to-negative trading, showing that strong clinical news does not always translate into immediate upside.

Key Terms

progression-free survival, overall survival, phase 3, non-covalent, +4 more

8 terms

progression-free survival medical

"improvement in progression-free survival (PFS), as assessed by an independent"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

overall survival medical

"Overall survival (OS), a key secondary endpoint, was not yet mature"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

phase 3 medical

"positive topline results from the Phase 3 BRUIN CLL-322 trial of Jaypirca"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

non-covalent medical

"Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase"

Non-covalent describes a type of interaction where molecules stick together through weak, reversible forces rather than forming permanent chemical bonds. For investors, non-covalent binding in drugs or diagnostics signals treatments that are often adjustable, shorter-acting, and potentially easier to reverse or fine-tune than covalent counterparts, which affects safety profiles, dosing strategies, patenting approaches and how a product may perform in the market.

bruton tyrosine kinase medical

"pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor"

Bruton tyrosine kinase (BTK) is a protein inside certain immune cells that acts like a control switch, helping those cells receive signals that tell them to grow, divide, or produce antibodies. It matters to investors because medicines that block or modify BTK can treat blood cancers and autoimmune diseases, so clinical results, regulatory decisions, or patent news about BTK-targeting drugs can materially affect the value of companies developing those therapies.

btk inhibitor medical

"non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, plus venetoclax"

A BTK inhibitor is a drug that blocks Bruton's tyrosine kinase, a protein that helps certain immune cells grow and communicate; by interrupting that signal it can reduce harmful immune activity or slow the growth of some blood cancers. For investors, BTK inhibitors matter because their clinical trial results, regulatory approvals, and market uptake can drive large, recurring sales or create competitive advantages for drugmakers, while failures or safety issues can sharply reduce a developer’s value—think of the drug as a targeted tool that can make or break a biotech’s prospects.

relapsed or refractory medical

"in patients with relapsed or refractory chronic lymphocytic leukemia"

"Relapsed or refractory" describes a situation where a disease, such as an illness or condition, returns after treatment or does not respond to initial treatment efforts. For investors, this indicates ongoing challenges or setbacks in managing the disease, which can affect the success of related treatments or therapies and impact the potential value of associated companies or products. Understanding this helps gauge the stability and future prospects of medical developments or healthcare investments.

label expansion regulatory

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

Label expansion is the process of getting official approval to add new approved uses, age groups, dosages or forms to a drug or medical device beyond its original approval. For investors, it matters because expanding a product’s labeled uses is like opening new doors to more customers and sales potential, often increasing revenue prospects, extending a product’s commercial life and reducing the risk tied to a single narrow market.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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BRUIN CLL-322 is the first Phase 3 readout in CLL to utilize and outperform a venetoclax-containing control arm

This trial predominantly enrolled a patient population previously treated with covalent BTK inhibitors, highly relevant to current practice

These results mark the fourth positive Phase 3 study of pirtobrutinib in CLL

INDIANAPOLIS, April 13, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 BRUIN CLL-322 trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, plus venetoclax and rituximab versus venetoclax and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). Treatment in both study arms was administered for up to two years, after which patients do not take any CLL therapy until their disease progresses. The study met its primary endpoint, demonstrating that the addition of pirtobrutinib to venetoclax plus rituximab led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS), as assessed by an independent review committee (IRC). Results were consistent across clinically relevant subgroups and regardless of whether patients were previously treated with a covalent BTK inhibitor.

Overall survival (OS), a key secondary endpoint, was not yet mature at this analysis, but was trending in favor of the pirtobrutinib combination regimen. The overall safety profile of this regimen was consistent with the known safety profile of each medicine. Rates of adverse events were similar across the study arms, with low rates of treatment regimen discontinuations, also similar between arms.

Detailed results will be presented at a medical congress and submitted to a peer-reviewed journal. Lilly intends to submit these results to regulators later this year for a label expansion.

"BRUIN CLL-322 was an ambitious trial, building on an effective regimen, and these results outperformed our expectations," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "Modern CLL treatment regimens provide such durable disease control that the vast majority of patients see their entire disease course managed by only one or two lines of therapy. For doctors and patients who prefer a time-limited approach, these BRUIN CLL-322 data demonstrate that the addition of Jaypirca could further extend the duration of benefit in second line CLL. Together with the other Phase 3 data recently published from the BRUIN clinical program, these data reinforce the potential role that pirtobrutinib may have, whether as a time-limited combination as a second line treatment or as a continuously dosed monotherapy in either line of therapy. We look forward to sharing the detailed data later this year and pursuing regulatory approvals to enable broad access."

These data build on the previously reported positive results from the BRUIN Phase 1/2 trial, the Phase 3 BRUIN CLL-321 trial, the first randomized, controlled study ever conducted in an exclusively post-covalent BTK inhibitor population, the Phase 3 BRUIN CLL-314 trial, the first-ever head-to-head Phase 3 trial versus ibrutinib in CLL to include treatment-naïve patients, and the BRUIN CLL-313 trial, the first prospective, randomized Phase 3 study to examine the efficacy and safety of a non-covalent BTK inhibitor exclusively in patients with treatment-naïve CLL. For more information on the BRUIN Phase 3 clinical trial program, please visit clinicaltrials.gov.

About BRUIN CLL-322
BRUIN CLL-322 is a global, randomized, open-label, Phase 3 study comparing time-limited pirtobrutinib plus venetoclax and rituximab versus venetoclax and rituximab in previously treated CLL/SLL patients. The trial enrolled 639 patients, who were randomized 1:1 to receive pirtobrutinib (200 mg, once daily) plus venetoclax and rituximab per their labeled doses or venetoclax and rituximab alone. The primary endpoint is PFS as assessed by blinded IRC. Secondary endpoints include PFS as assessed by investigator, OS, time to next treatment, event-free survival, overall response rate, time to worsening of CLL/SLL-related symptoms, time to worsening of physical functioning, safety and tolerability.

About Jaypirca (pirtobrutinib) 
Jaypirca (pirtobrutinib) (pronounced jay-pihr-kaa) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent (reversible) inhibitor of the enzyme BTK.¹ BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).^2,3 Jaypirca is a U.S. FDA-approved oral prescription medicine, 100 mg or 50 mg tablets taken as a once-daily 200 mg dose with or without food until disease progression or unacceptable toxicity.

INDICATIONS FOR JAYPIRCA (pirtobrutinib)
Jaypirca is indicated for the treatment of

• Adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.
• Adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical trial benefit in a confirmatory trial. 

IMPORTANT SAFETY INFORMATION FOR JAYPIRCA (pirtobrutinib)

Infections: Fatal and serious infections (including bacterial, viral, fungal) and opportunistic infections occurred in Jaypirca-treated patients. Across clinical trials, Grade ≥3 infections occurred (25%), most commonly pneumonia (20%); fatal infections (5%), sepsis (6%), and febrile neutropenia (3.8%) occurred. In patients with CLL/SLL, Grade ≥3 infections occurred (32%), with fatal infections occurring in 8%. Opportunistic infections included Pneumocystis jirovecii pneumonia and fungal infection. Consider prophylaxis, including vaccinations and antimicrobial prophylaxis, in patients at increased risk for infection, including opportunistic infections. Monitor for signs and symptoms, evaluate, and treat. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

Hemorrhage: Fatal and serious hemorrhage has occurred with Jaypirca. Across clinical trials, major hemorrhage (Grade ≥3 bleeding or any central nervous system bleeding) occurred (2.6%), including gastrointestinal hemorrhage; fatal hemorrhage occurred (0.3%). Bleeding of any grade, excluding bruising and petechiae, occurred (16%). Major hemorrhage occurred when taking Jaypirca with (2.0%) and without (0.6%) antithrombotic agents. Consider risks/benefits of co-administering antithrombotic agents with Jaypirca. Monitor for signs of bleeding. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca. Consider withholding Jaypirca 3-7 days pre- and post-surgery based on surgery type and bleeding risk.

Cytopenias: Jaypirca can cause cytopenias, including neutropenia, thrombocytopenia, and anemia. Across clinical trials, Grade 3 or 4 cytopenias, including decreased neutrophils (27%), decreased platelets (13%), and decreased hemoglobin (11%), developed. Grade 4 decreased neutrophils (15%) and Grade 4 decreased platelets (6%) developed. Monitor complete blood counts regularly. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

Cardiac Arrhythmias: Cardiac arrhythmias occurred in patients taking Jaypirca. Across clinical trials, atrial fibrillation or flutter were reported in 3.4% of Jaypirca treated patients, with Grade 3 or 4 atrial fibrillation or flutter in 1.6%. Other serious cardiac arrhythmias such as supraventricular tachycardia and cardiac arrest occurred (0.4%). Cardiac risk factors such as hypertension or previous arrhythmias may increase risk. Monitor and manage signs and symptoms of arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea). Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

Second Primary Malignancies: Across clinical trials, second primary malignancies, including non-skin carcinomas, developed in 9% of Jaypirca-treated patients, most frequently non-melanoma skin cancer (4.4%). Other second primary malignancies included solid tumors (including genitourinary and breast cancers) and melanoma. Advise patients to use sun protection and monitor for development of second primary malignancies.

Hepatotoxicity, Including Drug-Induced Liver Injury (DILI): Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of DILI, has occurred in patients treated with BTK inhibitors, including Jaypirca. Evaluate bilirubin and transaminases at baseline and throughout Jaypirca treatment. For patients who develop abnormal liver tests after Jaypirca, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold Jaypirca. If DILI is confirmed, discontinue Jaypirca.

Embryo-Fetal Toxicity: Jaypirca can cause fetal harm. Administration of pirtobrutinib to pregnant rats caused embryo-fetal toxicity, including embryo-fetal mortality and malformations at maternal exposures (AUC) approximately 3-times the recommended 200 mg/day dose. Advise pregnant women of fetal risk and females of reproductive potential to use effective contraception during treatment and for one week after last dose.

Adverse Reactions (ARs) in Patients Who Received Jaypirca

The most common (≥30%) ARs in the pooled safety population of patients with hematologic malignancies (n=704) were decreased neutrophil count (54%), decreased hemoglobin (43%), decreased leukocytes (32%), fatigue (31%), decreased platelets (31%), decreased lymphocyte count (31%), calcium decreased (30%).

Mantle Cell Lymphoma

Serious ARs occurred in 38% of patients, with pneumonia (14%), COVID-19 (4.7%), musculoskeletal pain (3.9%), hemorrhage (2.3%), pleural effusion (2.3%), and sepsis (2.3%) occurring in ≥2% of patients. Fatal ARs within 28 days of last dose occurred in 7% of patients, most commonly due to infections (4.7%), including COVID-19 (3.1% of all patients).

Dose Modifications and Discontinuations Due to ARs: Dose reductions in 4.7%, treatment interruption in 32%, and permanent discontinuation of Jaypirca in 9% of patients. Permanent discontinuation in >1% of patients included pneumonia.

Most common ARs (≥15%) and Select Laboratory Abnormalities (≥10%) (all Grades %; Grade 3-4 %): hemoglobin decreased (42; 9), platelet count decreased (39; 14), neutrophil count decreased (36; 16), lymphocyte count decreased (32; 15), creatinine increased (30; 1.6), fatigue (29; 1.6), musculoskeletal pain (27; 3.9), calcium decreased (19; 1.6), diarrhea (19; -), edema (18; 0.8), dyspnea (17; 2.3), AST increased (17; 1.6), pneumonia (16; 14), bruising (16; -), potassium decreased (13; 1.6), sodium decreased (13; -), lipase increased (12; 4.4), ALT increased (11; 1.6), potassium increased (11; 0.8), alkaline phosphatase increased (11; -). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (10), platelets decreased (7), lymphocytes decreased (6).

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma from Single-Arm and Randomized Controlled Clinical Trials

Serious ARs occurred in 47-56% of patients across clinical trials. Serious ARs in ≥5% of patients in the single-arm trial were pneumonia (18%), COVID-19 (9%), sepsis (7%), febrile neutropenia (7%). Serious ARs in ≥3% of patients in the randomized controlled trial were pneumonia (21%), COVID-19 (5%), sepsis (3.4%). Fatal ARs within 28-30 days of last Jaypirca dose occurred in 8-11% of patients, most commonly due to infections (7-10%), including sepsis (5%), COVID-19 (2.7-5%), and pneumonia (3.4%).

Dose Modifications and Discontinuations Due to ARs: Dose reductions in 3.6-10%, treatment interruption in 42-51%, and permanent discontinuation of Jaypirca in 9-17% of patients. Permanent discontinuation in >1% of patients included second primary malignancy, pneumonia, COVID-19, neutropenia, sepsis, anemia, and cardiac arrythmias.

Most common ARs and Select Laboratory Abnormalities (≥20%) (all Grades %, Grade 3-4 %)--in a randomized controlled trial: neutrophil count decreased (54; 26), hemoglobin decreased (45; 10), platelet count decreased (37; 17), pneumonia (28; 16), ALT increased (25; 1.8), creatinine increased (25; -), calcium decreased (23; 0.9), sodium decreased (22; 0.9), bilirubin increased (21; 0.9), upper respiratory tract infections (21; 0.9); in a single-arm trial: neutrophil count decreased (63; 45), hemoglobin decreased (48; 19), calcium decreased (40; 2.8), fatigue (36; 2.7), bruising (36; -), cough (33; -), musculoskeletal pain (32; 0.9), platelet count decreased (30; 15), sodium decreased (30; -), COVID-19 (28; 7), pneumonia (27; 16), diarrhea (26; -), abdominal pain (25; 2.7), lymphocyte count decreased (23; 8), ALT increased (23; 2.8), AST increased (23; 1.9), creatinine increased (23; -), dyspnea (22; 2.7), hemorrhage (22; 2.7), lipase increased (21; 7), alkaline phosphatase increased (21; -), edema (21; -), nausea (21; -), pyrexia (20; 2.7), headache (20; 0.9). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (23).

Drug Interactions

Strong CYP3A Inhibitors: Concomitant use increased pirtobrutinib systemic exposure, which may increase risk of Jaypirca ARs. Avoid using strong CYP3A inhibitors with Jaypirca. If concomitant use is unavoidable, reduce Jaypirca dose according to approved labeling.

Strong or Moderate CYP3A Inducers: Concomitant use decreased pirtobrutinib systemic exposure, which may reduce Jaypirca efficacy. Avoid using Jaypirca with strong or moderate CYP3A inducers. If concomitant use with moderate CYP3A inducers is unavoidable, increase Jaypirca dose according to approved labeling.

Sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP Substrates: Use with Jaypirca increased their plasma concentrations, which may increase risk of ARs related to these substrates for drugs sensitive to minimal concentration changes. Follow recommendations for these sensitive substrates in their approved labeling.

Use in Specific Populations

Pregnancy and Lactation: Due to potential for Jaypirca to cause fetal harm, verify pregnancy status in females of reproductive potential prior to starting Jaypirca. Presence of pirtobrutinib in human milk is unknown. Advise women to use effective contraception and to not breastfeed while taking Jaypirca and for one week after last dose.

Geriatric Use: In the pooled safety population of patients with hematologic malignancies, patients aged ≥65 years experienced higher rates of Grade ≥3 ARs and serious ARs compared to patients <65 years of age.

Renal Impairment: Because severe renal impairment increases pirtobrutinib exposure, reduce Jaypirca dose in these patients according to approved labeling.

PT HCP ISI MCL_CLL Q42025

Please see Prescribing Information and Patient Information for Jaypirca.

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY

© Lilly USA, LLC 2026. ALL RIGHTS RESERVED.

Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jaypirca (pirtobrutinib), as a potential treatment for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), and the timeline for future regulatory submissions, presentations, and other milestones relating to Jaypirca and its clinical trials, and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, or that Jaypirca will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Endnotes & References

1. Mato AR, Shah NN, Jurczak W, et al. Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a phase 1/2 study. Lancet. 2021;397(10277):892-901. doi:10.1016/S0140-6736(21)00224-5
2. Hanel W, Epperla N. Emerging therapies in mantle cell lymphoma. J Hematol Oncol. 2020;13(1):79. Published 2020 Jun 17. doi:10.1186/s13045-020-00914-1
3. Gu D, Tang H, Wu J, Li J, Miao Y. Targeting Bruton tyrosine kinase using non-covalent inhibitors in B cell malignancies. J Hematol Oncol. 2021;14(1):40. Published 2021 Mar 6. doi:10.1186/s13045-021-01049-7

 

Refer to:	Kyle Owens; Owens_Kyle@lilly.com; 332-259-3932 – (Media)
	Michael Czapar; czapar_michael_c@lilly.com; 317-617-0983 (Investors)

 

 

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SOURCE Eli Lilly and Company

FAQ

What did Lilly announce on April 13, 2026 about Jaypirca (LLY) in CLL?

Lilly announced that adding Jaypirca to venetoclax plus rituximab produced a statistically significant PFS improvement in Phase 3 BRUIN CLL-322. According to Lilly, results were consistent across subgroups and will be submitted to regulators later in 2026.

How did the Jaypirca combination perform for patients previously treated with covalent BTK inhibitors (LLY)?

The Jaypirca combination showed consistent benefit regardless of prior covalent BTK inhibitor therapy. According to Lilly, subgroup results were consistent and the trial predominantly enrolled patients treated with covalent BTK inhibitors, aligning with current clinical practice.

What does the BRUIN CLL-322 safety data say about Jaypirca plus venetoclax and rituximab (LLY)?

Safety was reported as consistent with known profiles and adverse event rates were similar between arms. According to Lilly, treatment-regimen discontinuations were low and comparable, indicating no new major safety signals in this topline readout.

Will Lilly seek regulatory approval for the Jaypirca combination after the BRUIN CLL-322 results (LLY)?

Yes. Lilly intends to submit BRUIN CLL-322 results to regulators later in 2026 for a potential label expansion. According to Lilly, detailed results will also be presented at a medical congress and submitted for peer-reviewed publication.

Did the BRUIN CLL-322 trial show an overall survival (OS) benefit for Jaypirca (LLY)?

Overall survival was not yet mature at analysis but was trending in favor of the Jaypirca combination. According to Lilly, OS remains a key secondary endpoint and additional follow-up is needed to determine definitive survival impact.