Results from the BRUIN CLL-314 study comparing Jaypirca (pirtobrutinib) to Imbruvica (ibrutinib) – the first-ever head-to-head Phase 3 study versus a covalent BTK inhibitor to include treatment-naïve CLL/SLL patients – will be presented as an oral presentation

BRUIN CLL-314 研究的结果将作为口头报告展示，该研究比较了 Jaypirca（pirtobrutinib）与 Imbruvica（ibrutinib）——这是首个针对初治 CLL/SLL 患者与共价 BTK 抑制剂进行头对头比较的 3 期研究。

Results from the Phase 3 BRUIN CLL-313 study of pirtobrutinib in patients with treatment-naïve CLL/SLL will be featured as a late-breaking oral presentation

Pirtobrutinib针对初治CLL/SLL患者的3期BRUIN CLL-313研究结果将作为最新突破性口头报告展示

Both BRUIN CLL-314 and BRUIN CLL-313 were selected to be part of the official ASH press program

BRUIN CLL-314 和 BRUIN CLL-313 均被选为 ASH 官方新闻计划的一部分。

INDIANAPOLIS

印第安纳波利斯

,

，

Nov. 24, 2025

2025年11月24日

/PRNewswire/ --

/PRNewswire/ --

Eli Lilly and Company

礼来公司

(NYSE: LLY) today announced that data from studies of Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, will be presented at the 67

(NYSE: LLY) 今天宣布，关于 Jaypirca（pirtobrutinib）的研究数据将在第 67 届会议上公布，该药物是首个也是唯一获批的非共价（可逆）布鲁顿酪氨酸激酶（BTK）抑制剂。

th

th

American Society of Hematology

美国血液学会

(ASH) Annual Meeting and Exposition, taking place

(ASH) 年会及展览，正在举行

Dec. 6-9

12月6日-9日

in

在

Orlando, Florida

佛罗里达州奥兰多市

.

。

Key data presentations for Jaypirca include:

Jaypirca 的关键数据展示包括：

In an oral presentation, Lilly will share results from the BRUIN CLL-314 study, comparing pirtobrutinib to Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). Lilly previously announced that pirtobrutinib met the primary endpoint of response rate non-inferiority, favoring pirtobrutinib with a nominal P-value for superiority < 0.05.

在一场口头报告中，礼来公司将分享BRUIN CLL-314研究的结果，该研究比较了pirtobrutinib与Imbruvica（ibrutinib，一种共价BTK抑制剂）在慢性淋巴细胞白血病或小淋巴细胞淋巴瘤（CLL/SLL）患者中的疗效。礼来公司此前宣布，pirtobrutinib达到了主要终点，即反应率的非劣效性，并且名义上的优越性P值<0.05，倾向于pirtobrutinib。

BRUIN CLL-314 is the first-ever head-to-head Phase 3 study versus a covalent BTK inhibitor to include treatment-naïve patients. These results were also selected to be highlighted in the ASH Annual Meeting press program session on .

BRUIN CLL-314 是首个与共价 BTK 抑制剂进行头对头比较的第 3 阶段研究，且包含未接受过治疗的患者。这些结果还被选中在 ASH 年会的新闻项目会议中重点展示。

Dec. 7

12月7日

.

。

In a late-breaking oral presentation, Lilly will share results from the Phase 3 BRUIN CLL-313 study of pirtobrutinib versus chemoimmunotherapy in patients with treatment-naïve CLL/SLL without del(17p). Lilly previously announced the study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival with pirtobrutinib compared to chemoimmunotherapy.

在一场最新的口头报告中，礼来公司将分享三期BRUIN CLL-313研究的结果，该研究对比了在未接受过治疗且无del(17p)的CLL/SLL患者中，皮托布替尼与化学免疫疗法的效果。礼来公司此前已宣布，该研究达到了主要终点，证明与化学免疫疗法相比，皮托布替尼在无进展生存期方面取得了高度统计学意义和临床意义上的显著改善。

These results were also selected to be highlighted in the ASH Annual Meeting press program session on .

这些结果还被选中在 ASH 年会的新闻计划会议中重点介绍。

Dec. 8

12月8日

.

。

In other oral and poster presentations, Lilly will share additional data from the Phase 1/2 BRUIN study in patients with relapsed or refractory CLL, mantle cell lymphoma (MCL) and Waldenström macroglobulinemia (WM). These long-term data include efficacy and safety results with approximately five years of follow-up..

在其他口头和海报展示中，礼来公司将分享来自BRUIN 1/2期研究的更多数据，该研究针对复发或难治性慢性淋巴细胞白血病（CLL）、套细胞淋巴瘤（MCL）和华氏巨球蛋白血症（WM）患者。这些长期数据包括大约五年的随访中的疗效和安全性结果。

In an oral presentation, results will be shared from an investigator-initiated Phase 2 study of time-limited treatment with a combination of pirtobrutinib, venetoclax, and obinutuzumab in treatment-naïve CLL.

在一场口头报告中，将分享一项由研究者发起的二期临床试验结果，该试验针对未经治疗的慢性淋巴细胞白血病（CLL），使用pirtobrutinib、venetoclax和obinutuzumab联合进行限时治疗。

'Building on our previous announcements of positive topline results for the Phase 3 BRUIN CLL-313 and CLL-314 studies, we are excited to share the full results at ASH,' said

“基于我们之前公布的BRUIN CLL-313和CLL-314三期研究的积极顶线结果，我们很高兴在ASH上分享完整的结果，”

Jacob Van Naarden

雅各布·范·纳登

, executive vice president and president of Lilly Oncology. 'Collectively, data from across the pirtobrutinib development program and investigator-led studies reinforce the medicine's unique clinical profile and its potential role across treatment settings and B-cell malignancies.'

礼来肿瘤事业部执行副总裁兼总裁。“总体而言，来自pirtobrutinib开发项目和研究者主导的研究的数据进一步证实了该药物独特的临床特征及其在各种治疗环境和B细胞恶性肿瘤中的潜在作用。”

A full list of abstract titles and viewing details are listed below:

以下列出了摘要标题和观看详情的完整列表：

Abstract Title

摘要标题

Author

作者

Presentation

演示

Type/#

类型/#

Session Title

会议标题

Session

会话

Date/Time

日期/时间

(EST)

(东部标准时间)

Pirtobrutinib in relapsed/refractory (R/R)

Pirtobrutinib在复发/难治性（R/R）

Waldenström macroglobulinemia (WM): Up

华氏巨球蛋白血症 (WM): 上升

to 5 years of follow-up from the Phase 1/2

长达5年的1/2期随访

BRUIN study

BRUIN研究

Chan Cheah

陈志伟

Oral

口服

Abstract

摘要

#226

#226

623. Mantle Cell,

623. 套细胞，

Follicular,

滤泡性，

Waldenstrom's,

华氏巨球蛋白血症，

and Other

和其他

Indolent B Cell

惰性B细胞

Lymphomas:

淋巴瘤：

Clinical and

临床和

Epidemiological:

流行病学的：

FL and WM

FL 和 WM

Saturday,

星期六，

Dec. 6

12月6日

2:45-3

2:45-3

p.m. EST

下午（东部标准时间）

Real-world treatment patterns, patient

现实世界的治疗模式，患者

characteristics, and outcomes of cBTKi-based

基于cBTKi的特性、结果

therapies amongst a contemporary cohort of

当代群体中的疗法

patients with R/R MCL in

复发/难治性套细胞淋巴瘤（R/R MCL）患者

the United States

美国

Kami

神

Maddocks

马多克斯

Poster

海报

Abstract

摘要

#2725

#2725

906. Outcomes

906. 结果

Research:

研究：

Lymphoid

淋巴的

Malignancies

恶性肿瘤

Excluding Plasma

排除等离子体

Cell Disorders:

细胞疾病：

Poster I

海报一

Saturday,

星期六，

Dec. 6

12月6日

5:30-7:30

5:30-7:30

p.m. EST

美国东部时间下午

Real-world characteristics, treatment

现实世界的特点，治疗

patterns and outcomes of patients with

模式与患者的结果

mantle cell lymphoma (MCL) after receiving

接受治疗后的套细胞淋巴瘤 (MCL)

covalent Bruton tyrosine kinase inhibitors

共价布鲁顿酪氨酸激酶抑制剂

(cBTKi) in China

（cBTKi）在中国

Yuqin Song

宋玉琴

Poster

海报

Abstract

摘要

#2704

#2704

906. Outcomes

906. 结果

Research:

研究：

Lymphoid

淋巴的

Malignancies

恶性肿瘤

Excluding Plasma

排除等离子体

Cell Disorders:

细胞疾病：

Poster I

海报一

Saturday,

星期六，

Dec. 6

12月6日

5:30-7:30

5:30-7:30

p.m. EST

下午（东部标准时间）

Pirtobrutinib in post-cBTKi CLL/SLL: Final

Pirtobrutinib 在 cBTKi 后的 CLL/SLL：最终结果

update from the Phase 1/2 BRUIN study with

更新来自1/2期BRUIN研究的

more than 5 years follow-up

超过5年的随访

William

威廉

Wierda

韦尔达

Poster

海报

Abstract

摘要

#2115

#2115

642. Chronic

642. 慢性的

Lymphocytic

淋巴细胞的

Leukemia: Clinical

白血病：临床

and

和

Epidemiological:

流行病学的：

Poster I

海报一

Saturday,

星期六，

Dec. 6

12月6日

5:30-7:30

5:30-7:30

p.m. EST

下午（东部标准时间）

Pirtobrutinib in relapsed/refractory (R/R)

Pirtobrutinib 在复发/难治性 (R/R) 中

mantle cell lymphoma (MCL): final update

套细胞淋巴瘤 (MCL): 最终更新

from the Phase 1/2 BRUIN study

来自1/2期BRUIN研究

Michael

迈克尔

Wang

王

Oral

口服

Abstract

摘要

#665

#665

623. Mantle Cell,

623. 套细胞，

Follicular,

滤泡性，

Waldenstrom's,

华氏巨球蛋白血症，

and Other

和其他

Indolent B Cell

惰性B细胞

Lymphomas:

淋巴瘤：

Clinical and

临床和

Epidemiological -

流行病学的 -

Novel Treatments

新型治疗方案

for and Insights

为了与洞察

into Mantle Cell

进入 mantle 细胞

Lymphoma

淋巴瘤

Sunday,

星期日，

Dec. 7

12月7日

5:30-5:45

5:30-5:45

p.m. EST

下午东部标准时间

Pirtobrutinib vs ibrutinib in treatment-naïve

Pirtobrutinib 与 Ibrutinib 在初治患者中的对比

and relapsed/refractory CLL/SLL: Results

复发/难治性CLL/SLL：结果

from the first randomized Phase 3

从第一个随机化的第三阶段

study comparing a non-covalent and

比较非共价和

covalent BTK inhibitor

共价BTK抑制剂

Jennifer

詹妮弗

Woyach

沃亚奇

Oral

口服

Abstract

摘要

#683

#683

642. Chronic

642. 慢性的

Lymphocytic

淋巴细胞的

Leukemia: Clinical

白血病：临床

and

和

Epidemiological:

流行病学的：

Frontline

前线

Treatment

治疗

Strategies for CLL

慢性淋巴细胞白血病的策略

Sunday,

星期日，

Dec. 7

12月7日

5:30-5:45

5:30-5:45

p.m. EST

下午（东部标准时间）

Efficacy of pirtobrutinib monotherapy in

Pirtobrutinib单药治疗的疗效

treatment-naïve chronic lymphocytic

治疗初治的慢性淋巴细胞白血病

leukemia: A Bayesian network meta-analysis

白血病：贝叶斯网络荟萃分析

of randomized controlled trials

随机对照试验

Toby Eyre

托比·艾尔

Poster

海报

Abstract

摘要

#5684

#5684

642. Chronic

642. 慢性的

Lymphocytic

淋巴细胞的

Leukemia: Clinical

白血病：临床

and

和

Epidemiological:

流行病学的：

Poster III

海报 III

Monday,

星期一，

Dec. 8

12月8日

6-8

6-8

p.m. EST

美国东部时间下午

Pirtobrutinib outcomes in second-line (2L)

Pirtobrutinib在二线治疗（2L）中的结果

chronic lymphocytic leukemia/small

慢性淋巴细胞白血病/小

lymphocytic lymphoma (CLL/SLL) after first-

淋巴细胞淋巴瘤（CLL/SLL）在首次治疗后

line (1L) cBTKi therapy: A pooled analysis

第1行 (1L) cBTKi治疗：汇总分析

from the BRUIN LOXO-BTK-18001 and BRUIN

来自BRUIN LOXO-BTK-18001和BRUIN

CLL-321 studies

CLL-321研究

Toby Eyre

托比·艾尔

Poster

海报

Abstract

摘要

#5670

#5670

642. Chronic

642. 慢性的

Lymphocytic

淋巴细胞的

Leukemia: Clinical

白血病：临床

and

和

Epidemiological:

流行病学的：

Poster III

海报 III

Monday,

星期一，

Dec. 8

12月8日

6-8

6-8

p.m. EST

下午东部标准时间

Pirtobrutinib vs bendamustine plus rituximab

皮托布替尼与苯达莫司汀加利妥昔单抗

(BR) in patients with CLL/SLL: First results

(BR) 在 CLL/SLL 患者中的应用：初步结果

from a randomized Phase 3 study examining

来自一项随机化的三期研究检查

a non-covalent BTK inhibitor in untreated

一种非共价BTK抑制剂，未经处理的

patients

病人

Wojciech

沃伊切赫

Jurczak

尤尔查克

Oral

口服

Abstract

摘要

#LBA-3

#LBA-3

Late-Breaking

最新突破

Abstracts Session

摘要会议

Tuesday,

星期二，

Dec. 9

12月9日

8-8:15

8-8:15

a.m. EST

美国东部时间上午

Investigator-Initiated

研究者发起的

Pirtobrutinib, venetoclax, and obinutuzumab

Pirtobrutinib、维奈托克和奥比妥珠单抗

for patients with Richter transformation: A

对于里希特转化的患者：A

Phase 2 trial

第二阶段试验

Nitin Jain

尼丁·贾恩

Oral

口服

Abstract

摘要

#89

#89

642. Chronic

642. 慢性的

Lymphocytic

淋巴细胞的

Leukemia: Clinical

白血病：临床

and

和

Epidemiological:

流行病学的：

Treatment of CLL

慢性淋巴细胞白血病的治疗

in Relapse and in

在复发和在

Richter

里希特

Transformation

转换

Saturday,

星期六，

Dec. 6

12月6日

10:30-10:45

10:30-10:45

a.m. EST

美国东部时间上午

High VGPR/CR rates with pirtobrutinib plus

高VGPR/CR率，使用pirtobrutinib联合治疗

venetoclax in previously treated

维奈托克在先前治疗中

Waldenström macroglobulinemia: Results

华氏巨球蛋白血症：结果

from a multicenter Phase 2 study

来自多中心的二期临床试验研究

Jorge Castillo

乔治·卡斯蒂略

Oral

口服

Abstract

摘要

#225

#225

623. Mantle Cell,

623. 套细胞，

Follicular,

滤泡性，

Waldenstrom's,

华氏巨球蛋白血症，

and Other

和其他

Indolent B Cell

惰性B细胞

Lymphomas:

淋巴瘤：

Clinical and

临床和

Epidemiological:

流行病学的：

FL and WM

FL 和 WM

Saturday,

星期六，

Dec. 6

12月6日

2:30-2:45

2:30-2:45

p.m. EST

下午（东部标准时间）

Time-limited pirtobrutinib, venetoclax, and

限时使用的pirtobrutinib、venetoclax和

obinutuzumab combination in first-line

奥滨尤妥珠单抗联合一线治疗

chronic lymphocytic leukemia

慢性淋巴细胞白血病

Nitin Jain

尼丁·贾恩

Oral

口服

Abstract

摘要

#680

#680

642. Chronic

642. 慢性的

Lymphocytic

淋巴细胞的

Leukemia: Clinical and

白血病：临床与

Epidemiological:

流行病学的：

Frontline

前线

Treatment

治疗

Strategies for CLL

慢性淋巴细胞白血病的策略

Sunday,

星期日，

Dec. 7

12月7日

4:45-5

4点45分至5点

p.m. EST

下午（东部标准时间）

Pirtobrutinib, a non-covalent BTK inhibitor,

Pirtobrutinib，一种非共价BTK抑制剂，

enhances T-cell anti-tumor immunity in

增强T细胞抗肿瘤免疫能力

chronic lymphocytic leukemia (CLL)

慢性淋巴细胞白血病 (CLL)

Sonia

索尼娅

Rodriguez-

罗德里格斯-

Rodriguez

罗德里格斯

Poster

海报

Abstract

摘要

#3878

#3878

641. Chronic

641. 慢性的

Lymphocytic

淋巴细胞的

Leukemia: Basic

白血病：基础

and

和

Translational:

转换性：

Poster II

海报 II

Sunday,

星期日，

Dec. 7

12月7日

6-8

6-8

p.m. EST

下午（东部标准时间）

Pirtobrutinib versus usual care for patients

Pirtobrutinib与常规治疗对患者的比较

with Richter transformation of chronic

伴有慢性 Richter 转化

lymphocytic leukemia: Inverse probability of

淋巴细胞白血病：逆概率

treatment weighting-based analysis of BRUIN

基于治疗权重的BRUIN分析

trial and mayo observational cohort

试验和梅奥观察队列

Yucai Wang

王育才

Poster

海报

Abstract

摘要

#5673

#5673

642. Chronic

642. 慢性的

Lymphocytic

淋巴细胞的

Leukemia: Clinical

白血病：临床

and

和

Epidemiological:

流行病学的：

Poster III

海报 III

Monday,

星期一，

Dec. 8

12月8日

6-8

6-8

p.m. EST

下午（东部标准时间）

About Jaypirca (pirtobrutinib)

关于Jaypirca（pirtobrutinib）

Jaypirca (pirtobrutinib, formerly known as LOXO-305) (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.

Jaypirca（pirtobrutinib，以前称为 LOXO-305）（发音为 jay-pihr-kaa）是一种高选择性（在临床前研究中，对 BTK 的选择性比 98% 的其他激酶高出 300 倍）、非共价（可逆）的 BTK 酶抑制剂。

1

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).

BTK是存在于多种B细胞白血病和淋巴瘤中的一个已验证的分子靶点，包括套细胞淋巴瘤（MCL）和慢性淋巴细胞白血病（CLL）。

2,3

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.

Jaypirca 是一种经美国 FDA 批准的口服处方药，每日一次服用 200 毫克（100 毫克或 50 毫克片剂），可随餐或空腹服用，直至疾病进展或出现不可接受的毒性。

INDICATIONS FOR JAYPIRCA (pirtobrutinib)

JAYPIRCA（pirtobrutinib）的适应症

Jaypirca is a kinase inhibitor indicated for the treatment of

Jaypirca 是一种激酶抑制剂，用于治疗

Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.

接受过至少两线系统治疗（包括BTK抑制剂）后复发或难治性套细胞淋巴瘤（MCL）的成年患者。

Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

接受过至少两种既往治疗（包括BTK抑制剂和BCL-2抑制剂）的慢性淋巴细胞白血病或小淋巴细胞淋巴瘤（CLL/SLL）成年患者。

These indications are approved under accelerated approval based on response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial.

这些适应症是基于缓解率通过加速审批程序批准的。对这些适应症的持续批准可能取决于在确证性试验中对临床获益的验证和描述。

IMPORTANT SAFETY INFORMATION FOR JAYPIRCA

JAYPIRCA的重要安全信息

(pirtobrutinib)

(pirtobrutinib)

Infections:

感染：

Fatal and serious infections (including bacterial, viral, fungal) and opportunistic infections occurred in Jaypirca-treated patients. In a clinical trial, Grade ≥3 infections occurred in 24% of patients with hematologic malignancies, most commonly pneumonia (14%); fatal infections occurred (4.4%). Sepsis (6%) and febrile neutropenia (4%) occurred.

在接受Jaypirca治疗的患者中发生了致命和严重的感染（包括细菌、病毒、真菌）以及机会性感染。在一项临床试验中，24%的血液系统恶性肿瘤患者发生了3级或更高级别的感染，其中最常见的是肺炎（14%）；发生致命感染的比例为4.4%。败血症（6%）和发热性中性粒细胞减少（4%）也有发生。

In patients with CLL/SLL, Grade ≥3 infections occurred (32%), with fatal infections occurring in 8%. Opportunistic infections included .

在CLL/SLL患者中，≥3级感染发生率为32%，其中8%为致命感染。机会性感染包括 。

Pneumocystis jirovecii

肺炎链球菌

pneumonia and fungal infection. Consider prophylaxis, including vaccinations and antimicrobial prophylaxis, in patients at increased risk for infection, including opportunistic infections. Monitor patients for signs and symptoms, evaluate promptly, and treat appropriately. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca. .

肺炎和真菌感染。对于感染风险增加的患者，包括机会性感染，考虑进行预防，包括疫苗接种和抗菌预防。监测患者的症状和体征，迅速评估并适当治疗。根据严重程度，减少剂量、暂时停药或永久停用Jaypirca。

Hemorrhage:

出血：

Fatal and serious hemorrhage has occurred with Jaypirca. Major hemorrhage (Grade ≥3 bleeding or any central nervous system bleeding) occurred in 3% of patients, including gastrointestinal hemorrhage; fatal hemorrhage occurred (0.3%). Bleeding of any grade, excluding bruising and petechiae, occurred (17%).

Jaypirca曾发生过致命和严重的出血。3%的患者发生了严重出血（≥3级出血或任何中枢神经系统出血），包括胃肠道出血；0.3%的患者发生了致命性出血。任何等级的出血（不包括瘀伤和瘀点）发生率为17%。

Major hemorrhage occurred in patients taking Jaypirca with (0.7%) and without (2.3%) antithrombotic agents. Consider risks/benefits of co-administering antithrombotic agents with Jaypirca. Monitor patients for signs of bleeding. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

服用Jaypirca的患者中，使用抗血栓药物的患者发生严重出血的比例为0.7%，未使用的患者比例为2.3%。考虑将抗血栓药物与Jaypirca联合使用的风险/收益。监测患者的出血迹象。根据严重程度，减少剂量、暂时停药或永久停用Jaypirca。

Consider benefit/risk of withholding Jaypirca 3-7 days pre- and post-surgery depending on type of surgery and bleeding risk. .

根据手术类型和出血风险，考虑在手术前后 3-7 天停用 Jaypirca 的益处/风险。

Cytopenias:

血细胞减少症：

Jaypirca can cause cytopenias, including neutropenia, thrombocytopenia, and anemia. In a clinical trial, Grade 3 or 4 cytopenias, including decreased neutrophils (26%), decreased platelets (12%), and decreased hemoglobin (12%), developed in Jaypirca-treated patients. Grade 4 decreased neutrophils (14%) and Grade 4 decreased platelets (6%) developed.

Jaypirca可能引起细胞减少症，包括中性粒细胞减少、血小板减少和贫血。在一项临床试验中，接受Jaypirca治疗的患者出现了3级或4级细胞减少症，包括中性粒细胞减少（26%）、血小板减少（12%）和血红蛋白减少（12%）。其中，4级中性粒细胞减少（14%）和4级血小板减少（6%）发生。

Monitor complete blood counts regularly during treatment. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca. .

在治疗期间定期监测全血细胞计数。根据严重程度，减少剂量、暂时停药或永久停用Jaypirca。

Cardiac Arrhythmias:

心律失常：

Cardiac arrhythmias occurred in patients who received Jaypirca. In a clinical trial of patients with hematologic malignancies, atrial fibrillation or flutter were reported in 3.2% of Jaypirca-treated patients, with Grade 3 or 4 atrial fibrillation or flutter in 1.5%. Other serious cardiac arrhythmias such as supraventricular tachycardia and cardiac arrest occurred (0.5%).

接受Jaypirca治疗的患者出现了心律失常。在一项针对血液系统恶性肿瘤患者的临床试验中，3.2%的Jaypirca治疗患者报告了心房颤动或扑动，其中1.5%为3级或4级心房颤动或扑动。其他严重的心律失常，如室上性心动过速和心脏骤停，也有发生（0.5%）。

Patients with cardiac risk factors such as hypertension or previous arrhythmias may be at increased risk. Monitor for signs and symptoms of arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea) and manage appropriately. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca. .

具有高血压或既往心律失常等心脏风险因素的患者可能面临更高风险。监测心律失常的体征和症状（如心悸、头晕、晕厥、呼吸困难），并进行适当管理。根据严重程度，减少剂量、暂时停药或永久停用Jaypirca。

Second Primary Malignancies:

第二原发恶性肿瘤：

Second primary malignancies, including non-skin carcinomas, developed in 9% of Jaypirca-treated patients. The most frequent malignancy was non-melanoma skin cancer (4.6%). 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. .

在接受Jaypirca治疗的患者中，有9%发生了包括非皮肤癌在内的第二原发恶性肿瘤。最常见的恶性肿瘤为非黑色素瘤皮肤癌（4.6%）。其他第二原发恶性肿瘤包括实体瘤（包括泌尿生殖系统癌症和乳腺癌）以及黑色素瘤。建议患者使用防晒措施，并监测第二原发恶性肿瘤的发生。

Hepatotoxicity, Including Drug-Induced Liver Injury (DILI):

肝毒性，包括药物性肝损伤（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.

接受BTK抑制剂（包括Jaypirca）治疗的患者已出现肝毒性，包括严重、危及生命且可能致命的药物性肝损伤（DILI）。在基线时及整个Jaypirca治疗期间评估胆红素和转氨酶水平。对于在使用Jaypirca后出现肝功能检查异常的患者，应更频繁地监测肝功能检查异常以及肝毒性的临床症状和体征。

If DILI is suspected, withhold Jaypirca. Upon confirmation of DILI, discontinue Jaypirca. .

如果怀疑出现DILI，应暂停使用Jaypirca。一旦确认DILI，应停止使用Jaypirca。

Embryo-Fetal Toxicity:

胚胎-胎儿毒性：

Jaypirca can cause fetal harm in pregnant women. 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 potential fetal risk and females of reproductive potential to use effective contraception during treatment and for one week after last dose. .

Jaypirca 会对孕妇造成胎儿伤害。在怀孕大鼠中使用 pirtobrutinib 会导致胚胎-胎儿毒性，包括胚胎-胎儿死亡和畸形，母体暴露量（AUC）约为推荐的每日 200 毫克剂量的三倍。建议孕妇注意潜在的胎儿风险，并建议有生育潜力的女性在治疗期间及最后一剂后的一周内使用有效的避孕措施。

Adverse Reactions (ARs) in Patients Who Received Jaypirca

接受Jaypirca治疗的患者中的不良反应（ARs）

The most common (≥20%) ARs in the BRUIN pooled safety population of patients with hematologic malignancies (n=593) were decreased neutrophil count (46%), decreased hemoglobin (39%), fatigue (32%), decreased lymphocyte count (31%), musculoskeletal pain (30%), decreased platelet count (29%), diarrhea (24%), COVID-19 (22%), bruising (21%), cough (20%). .

在BRUIN汇集的安全性人群中，血液系统恶性肿瘤患者（n=593）最常见的（≥20%）不良反应（AR）为中性粒细胞计数减少（46%）、血红蛋白减少（39%）、疲劳（32%）、淋巴细胞计数减少（31%）、肌肉骨骼疼痛（30%）、血小板计数减少（29%）、腹泻（24%）、COVID-19（22%）、瘀伤（21%）、咳嗽（20%）。

Mantle Cell Lymphoma

套细胞淋巴瘤

Serious ARs

严肃的AR（增强现实）应用

occurred in 38% of patients. Serious ARs occurring in ≥2% of patients were pneumonia (14%), COVID-19 (4.7%), musculoskeletal pain (3.9%), hemorrhage (2.3%), pleural effusion (2.3%), and sepsis (2.3%).

发生在38%的患者中。在≥2%的患者中发生的严重AR包括肺炎（14%）、COVID-19（4.7%）、肌肉骨骼疼痛（3.9%）、出血（2.3%）、胸腔积液（2.3%）和败血症（2.3%）。

Fatal ARs

致命AR

within 28 days of last Jaypirca dose occurred in 7% of patients, most commonly due to infections (4.7%), including COVID-19 (3.1% of all patients).

在最后使用Jaypirca的28天内，有7%的患者发生了不良反应，最常见的原因是感染（4.7%），其中包括COVID-19（占所有患者的3.1%）。

Dose Modifications and Discontinuations:

剂量调整与停药：

ARs led to dose reductions in 4.7%, treatment interruption in 32%, and permanent discontinuation of Jaypirca in 9% of patients. ARs resulting in dosage modification in >5% of patients included pneumonia and neutropenia. ARs resulting in permanent discontinuation in >1% of patients included pneumonia. .

不良反应导致4.7%的患者剂量减少，32%的患者治疗中断，9%的患者永久停用Jaypirca。导致超过5%的患者调整剂量的不良反应包括肺炎和中性粒细胞减少症。导致超过1%的患者永久停药的不良反应包括肺炎。

Most common ARs (

最常见的AR（

≥

≥

15%), excluding laboratory terms (all Grades %; Grade 3-4 %):

15%），排除实验室术语（所有等级 %；3-4级 %）：

fatigue (29; 1.6), musculoskeletal pain (27; 3.9), diarrhea (19; -), edema (18; 0.8), dyspnea (17; 2.3), pneumonia (16; 14), bruising (16; -).

疲劳 (29; 1.6)、肌肉骨骼疼痛 (27; 3.9)、腹泻 (19; -)、水肿 (18; 0.8)、呼吸困难 (17; 2.3)、肺炎 (16; 14)、瘀伤 (16; -)。

Select Laboratory Abnormalities (all Grades %; Grade 3 or 4 %) that Worsened from Baseline in

选择实验室异常（所有等级 %；3级或4级 %）从基线恶化的情况

≥

≥

10% of Patients:

10%的患者：

hemoglobin decreased (42; 9), platelet count decreased (39; 14), neutrophil count decreased (36; 16), lymphocyte count decreased (32; 15), creatinine increased (30; 1.6), calcium decreased (19; 1.6), AST increased (17; 1.6), potassium decreased (13; 1.6), sodium decreased (13; -), lipase increased (12; 4.4), alkaline phosphatase increased (11; -), ALT increased (11; 1.6), potassium increased (11; 0.8).

血红蛋白减少（42；9），血小板计数减少（39；14），中性粒细胞计数减少（36；16），淋巴细胞计数减少（32；15），肌酐增加（30；1.6），钙减少（19；1.6），AST增加（17；1.6），钾减少（13；1.6），钠减少（13；-），脂肪酶增加（12；4.4），碱性磷酸酶增加（11；-），ALT增加（11；1.6），钾增加（11；0.8）。

Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (10), platelets decreased (7), lymphocytes decreased (6). .

4级实验室异常在超过5%的患者中出现，包括中性粒细胞减少（10%）、血小板减少（7%）、淋巴细胞减少（6%）。

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

慢性淋巴细胞白血病/小淋巴细胞淋巴瘤

Serious ARs

严肃的AR（增强现实）

occurred in 56% of patients. Serious ARs occurring in ≥5% of patients were pneumonia (18%), COVID-19 (9%), sepsis (7%), and febrile neutropenia (7%).

发生在56%的患者中。严重不良反应发生在≥5%的患者中，包括肺炎（18%）、COVID-19（9%）、败血症（7%）和发热性中性粒细胞减少（7%）。

Fatal ARs

致命AR

within 28 days of last Jaypirca dose occurred in 11% of patients, most commonly due to infections (10%), including sepsis (5%) and COVID-19 (2.7%).

在最后使用Jaypirca后的28天内，11%的患者发生了不良反应，最常见的原因是感染（10%），包括败血症（5%）和新冠肺炎（2.7%）。

Dose Modifications and Discontinuations:

剂量调整和停药：

ARs led to dose reductions in 3.6%, treatment interruption in 42%, and permanent discontinuation of Jaypirca in 9% of patients. ARs resulting in dose reductions in >1% included neutropenia; treatment interruptions in >5% of patients included pneumonia, neutropenia, febrile neutropenia, and COVID-19; permanent discontinuation in >1% of patients included second primary malignancy, COVID-19, and sepsis. .

不良反应导致3.6%的患者剂量减少，42%的患者治疗中断，9%的患者永久停用Jaypirca。导致剂量减少的不良反应（发生率>1%）包括中性粒细胞减少；导致治疗中断的不良反应（发生率>5%）包括肺炎、中性粒细胞减少、发热性中性粒细胞减少和COVID-19；导致永久停药的不良反应（发生率>1%）包括第二原发恶性肿瘤、COVID-19和败血症。

Most common ARs (

最常见的AR（

≥

≥

20%), excluding laboratory terms (all Grades %; Grade 3-4 %):

20%)，排除实验室术语（所有等级 %；3-4级 %）：

fatigue (36; 2.7), bruising (36; -), cough (33; -), musculoskeletal pain (32; 0.9), COVID-19 (28; 7), pneumonia (27; 16), diarrhea (26; -), abdominal pain (25; 2.7), dyspnea (22; 2.7), hemorrhage (22; 2.7), edema (21; -), nausea (21; -), pyrexia (20; 2.7), headache (20; 0.9).

疲劳 (36; 2.7)、瘀伤 (36; -)、咳嗽 (33; -)、肌肉骨骼疼痛 (32; 0.9)、新冠肺炎 (28; 7)、肺炎 (27; 16)、腹泻 (26; -)、腹痛 (25; 2.7)、呼吸困难 (22; 2.7)、出血 (22; 2.7)、水肿 (21; -)、恶心 (21; -)、发热 (20; 2.7)、头痛 (20; 0.9)。

Select Laboratory Abnormalities (all Grades %; Grade 3 or 4 %) that Worsened from Baseline in

选择从基线恶化（所有等级 %；3级或4级 %）的实验室异常

≥

≥

20% of Patients:

20%的患者：

neutrophil count decreased (63; 45), hemoglobin decreased (48; 19), calcium decreased (40; 2.8), platelet count decreased (30; 15), sodium decreased (30; -), lymphocyte count decreased (23; 8), ALT increased (23; 2.8), AST increased (23; 1.9), creatinine increased (23; -), lipase increased (21; 7), alkaline phosphatase increased (21; -).

中性粒细胞计数减少 (63; 45)，血红蛋白减少 (48; 19)，钙减少 (40; 2.8)，血小板计数减少 (30; 15)，钠减少 (30; -)，淋巴细胞计数减少 (23; 8)，ALT升高 (23; 2.8)，AST升高 (23; 1.9)，肌酐升高 (23; -)，脂肪酶升高 (21; 7)，碱性磷酸酶升高 (21; -)。

Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (23). .

4级实验室异常在超过5%的患者中出现，包括中性粒细胞减少（23）。

Drug Interactions

药物相互作用

Strong CYP3A Inhibitors:

强效CYP3A抑制剂：

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

与Jaypirca同时使用会增加pirtobrutinib的全身暴露，这可能会增加Jaypirca的不良反应风险。避免将强效CYP3A抑制剂与Jaypirca一起使用。如果必须同时使用，请根据批准的标签说明减少Jaypirca的剂量。

Strong or Moderate CYP3A Inducers:

强效或中效CYP3A诱导剂：

Concomitant use with Jaypirca decreased pirtobrutinib systemic exposure, which may reduce Jaypirca efficacy. Avoid concomitant use of Jaypirca with strong or moderate CYP3A inducers. If concomitant use with moderate CYP3A inducers is unavoidable, increase Jaypirca dosage according to approved labeling. .

与Jaypirca同时使用会降低pirtobrutinib的全身暴露，这可能会减弱Jaypirca的疗效。避免将Jaypirca与强效或中效CYP3A诱导剂同时使用。如果无法避免与中效CYP3A诱导剂同时使用，应根据批准的标签说明增加Jaypirca的剂量。

Sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP Substrates:

敏感的CYP2C8、CYP2C19、CYP3A、P-gp或BCRP底物：

Concomitant use with Jaypirca increased their plasma concentrations, which may increase risk of adverse reactions related to these substrates for drugs that are sensitive to minimal concentration changes. Follow recommendations for these sensitive substrates in their approved labeling.

与Jaypirca同时使用会增加其血浆浓度，这可能会增加对最低浓度变化敏感的药物产生与其相关的不良反应的风险。请遵循这些敏感底物在批准标签中的建议。

Use in Special Populations

特定人群中的使用

Pregnancy and Lactation:

怀孕和哺乳：

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

由于 Jaypirca 可能对胎儿造成伤害，在开始使用 Jaypirca 之前，应确认育龄女性的怀孕状态，并建议在治疗期间及最后一剂后的一周内使用有效的避孕措施。目前尚不清楚 pirtobrutinib 是否会出现在母乳中。建议女性在服用 Jaypirca 期间及最后一剂后的一周内不要进行母乳喂养。

Geriatric Use:

老年患者使用：

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.

在患有血液系统恶性肿瘤的患者的安全性综合分析中，≥65岁的患者相较于<65岁的患者，出现≥3级不良反应（ARs）和严重不良反应（ARs）的比例更高。

Renal Impairment:

肾功能损害:

Severe renal impairment increases pirtobrutinib exposure. Reduce Jaypirca dosage in patients with severe renal impairment according to approved labeling.

严重肾功能损害会增加pirtobrutinib的暴露量。根据批准的标签说明，减少严重肾功能损害患者的Jaypirca剂量。

PT HCP ISI MCL_CLL AA JUN2024

PT HCP 内容 MCL_CLL AA 2024年6月

Please see

请参见

Prescribing Information

处方信息

and

和

Patient Information

患者信息

for Jaypirca.

适用于Jaypirca。

About Lilly

关于礼来

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.

礼来是一家医药公司，将科学转化为治疗手段，以改善世界各地人们的生活。近150年来，我们一直是改变生命的发现的先驱，如今我们的药物帮助了全球数千万人。通过利用生物技术、化学和基因医学的力量，我们的科学家正在加速推进新的发现，以解决一些全球最重要的健康挑战：重新定义糖尿病护理；治疗肥胖症并遏制其最具破坏性的长期影响；推动对抗阿尔茨海默病的斗争；为一些最令人衰弱的免疫系统疾病提供解决方案；并将最难治疗的癌症转化为可管理的疾病。

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 .

每迈向更健康的世界一步，我们都受到一个目标的激励：让更多数百万人的生活更美好。这包括开展反映世界多样性的创新临床试验，并努力确保我们的药品可及且负担得起。欲了解更多信息，请访问。

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Lilly.com/news

Lilly.com/新闻

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Facebook

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领英

. P-LLY

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©

©

Lilly USA, LLC

美国礼来公司

2025. ALL RIGHTS RESERVED.

2025. 保留所有权利。

Trademarks and Trade Names

商标和商号

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 .

本新闻稿中提到的所有商标或商号均为公司财产，或者，若涉及属于其他公司的商标或商号，则为各自所有者的财产。仅为方便起见，本新闻稿中提及的商标和商号未附加符号。

®

®

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. .

和™符号，但此类引用不应被解释为公司或在适用范围内其各自所有者不会根据适用法律最大程度地主张公司或其权利的任何指标。我们不打算通过使用或展示其他公司的商标和商号来暗示我们与其他公司之间的关系，或暗示其他公司对我们的认可或赞助。

Cautionary Statement Regarding Forward-Looking Statements

关于前瞻性声明的警告声明

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jaypirca as a potential treatment for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), mantle cell lymphoma (MCL) and Waldenström macroglobulinemia (WM), and reflects Lilly's current beliefs and expectations.

本新闻稿包含关于Jaypirca作为治疗成人慢性淋巴细胞白血病或小淋巴细胞淋巴瘤（CLL/SLL）、套细胞淋巴瘤（MCL）和华氏巨球蛋白血症（WM）的潜在疗法的前瞻性声明（该术语定义见1995年《私人证券诉讼改革法案》），并反映了礼来公司当前的信念和期望。

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.

然而，与任何药物产品一样，在药物研发、开发和商业化过程中存在重大风险和不确定性。其中，不能保证计划中或正在进行的研究会按计划完成，未来的研究结果会与迄今为止的研究结果一致，也不能保证Jaypirca将获得额外的监管批准。

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 .

有关这些可能导致实际结果与礼来公司预期不同的风险和其他不确定性的进一步讨论，请参见礼来公司向美国证券交易委员会提交的Form 10-K和Form 10-Q报告。

United States Securities and Exchange Commission

美国证券交易委员会

. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

除非法律要求，礼来公司没有义务更新前瞻性声明以反映本发布日期之后的事件。

Endnotes & References

尾注与参考文献

Mato AR, Shah NN, Jurczak W, et al. Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a Phase 1/2 study.

马托 AR，沙 NN，尤尔茨克 W，等。Pirtobrutinib 治疗复发或难治性 B 细胞恶性肿瘤 (BRUIN)：一项 1/2 期研究。

Lancet

柳叶刀

. 2021;397(10277):892-901. doi:10.1016/S0140-6736(21)00224-5

. 2021;397(10277):892-901. doi:10.1016/S0140-6736(21)00224-5

Hanel W, Epperla N. Emerging therapies in mantle cell lymphoma.

汉内尔·W，埃佩拉·N。套细胞淋巴瘤的新兴疗法。

J Hematol Oncol

血液学与肿瘤学杂志

. 2020;13(1):79. Published 2020 Jun 17. doi:10.1186/s13045-020-00914-1

. 2020;13(1):79. 发表于2020年6月17日。doi:10.1186/s13045-020-00914-1

Gu D, Tang H, Wu J, Li J, Miao Y. Targeting Bruton tyrosine kinase using non-covalent inhibitors in B cell malignancies.

顾D，唐H，吴J，李J，苗Y。在B细胞恶性肿瘤中使用非共价抑制剂靶向布鲁顿酪氨酸激酶。

J Hematol Oncol

血液学与肿瘤学杂志

. 2021;14(1):40. Published 2021 Mar 6. doi:10.1186/s13045-021-01049-7

. 2021;14(1):40. 发表于2021年3月6日。doi:10.1186/s13045-021-01049-7

Refer to:

参考：

Kyle Owens

凯尔·欧文斯

;

；

Owens_Kyle@lilly.com

欧文斯_凯尔@礼来公司.com

; (332) 259-3932 (Media)

；（332）259-3932（媒体）

Michael Czapar

迈克尔·察帕尔

;

；

czapar_michael_c@lilly.com

czapar_michael_c@lilly.com

; 317-617-0983 (Investors)

；317-617-0983（投资者）

View original content to download multimedia:

查看原始内容以下载多媒体：

https://www.prnewswire.com/news-releases/lilly-to-present-data-from-two-positive-phase-3-studies-of-jaypirca-pirtobrutinib-in-chronic-lymphocytic-leukemia-at-the-2025-american-society-of-hematology-ash-annual-meeting-302623695.html

https://www.prnewswire.com/news-releases/礼来将在2025年美国血液学会年会上公布JAYPIRCA（pirtobrutinib）治疗慢性淋巴细胞白血病的两项积极3期研究数据-302623695.html

SOURCE

源代码

Eli Lilly and Company

礼来公司