Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 BRUIN CLL-313 clinical trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, versus chemoimmunotherapy (bendamustine plus rituximab), in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions.

礼来公司 (NYSE: LLY) 今天宣布了三期临床试验 BRUIN CLL-313 的积极顶线结果，该试验涉及 Jaypirca（pirtobrutinib），一种非共价（可逆）布鲁顿酪氨酸激酶（BTK）抑制剂，与化学免疫疗法（苯达莫司汀加利妥昔单抗）对比，用于未经治疗的无17p缺失的慢性淋巴细胞白血病或小淋巴细胞淋巴瘤（CLL/SLL）患者。

The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemoimmunotherapy, as assessed by an independent review committee (IRC), indicating one of the most compelling effect sizes ever observed for a single agent BTK inhibitor in a front-line CLL study..

该研究达到了主要终点，与化学免疫疗法相比，独立审查委员会（IRC）评估显示，无进展生存期（PFS）取得了高度统计学显著性以及临床意义上的改善，这表明在一线CLL研究中，单药BTK抑制剂所展现出的效应量是迄今为止最引人注目的之一。

Overall survival (OS), a key secondary endpoint, was not yet mature at this analysis, but was trending strongly in favor of pirtobrutinib and will be tested for statistical significance at the time of the primary OS analysis, which is anticipated to occur in 2026. The overall safety profile of pirtobrutinib in BRUIN CLL-313 was generally consistent with previously reported trials across treatment settings..

总体生存期（OS）作为一个关键的次要终点，在本次分析时还未成熟，但显示出强烈倾向支持pirtobrutinib，并将在主要OS分析时进行统计学意义检验，预计这将在2026年进行。Pirtobrutinib在BRUIN CLL-313中的整体安全性特征与之前在不同治疗环境中报告的试验基本一致。

Detailed results will be presented at a medical congress and submitted to a peer-reviewed journal. The results from the BRUIN CLL-313 and BRUIN CLL-314 studies will form the basis for seeking label expansions in earlier lines of therapy, with global regulatory submissions beginning later this year.

详细结果将在医学大会上公布，并提交给同行评审期刊。BRUIN CLL-313 和 BRUIN CLL-314 研究的结果将为在更早的治疗阶段寻求标签扩展提供基础，全球监管提交将于今年晚些时候开始。

'The results from BRUIN CLL-313 are striking and provocative, across both PFS and OS endpoints, further demonstrating the potential of pirtobrutinib to be a meaningful treatment option for people with untreated CLL/SLL,' said

“BRUIN CLL-313研究的结果在无进展生存期和总生存期终点上都非常显著且引人深思，进一步证明了pirtobrutinib作为未经治疗的CLL/SLL患者有意义的治疗选择的潜力，”研究人员表示。

Jacob Van Naarden

雅各布·范·纳登

, executive vice president and president of Lilly Oncology. 'With this third positive Phase 3 study, we continue to build the clinical evidence supporting the possible role of pirtobrutinib in a variety of CLL/SLL treatment settings, including treatment-naïve, BTK inhibitor-naïve and BTK inhibitor exposed.

，执行副总裁兼礼来肿瘤事业部总裁。“通过这次第三项积极的三期研究，我们继续积累支持pirtobrutinib在各种CLL/SLL治疗环境中可能发挥作用的临床证据，包括初治、BTK抑制剂初治和BTK抑制剂暴露的患者。”

We look forward to presenting these data, as well as data from the recently announced positive BRUIN CLL-314 study, at upcoming medical meetings and preparing global regulatory submissions, with the goal of making pirtobrutinib an option for a wider group of patients who might benefit.'.

我们期待在即将召开的医学会议上展示这些数据，以及最近宣布的积极的BRUIN CLL-314研究的数据，并准备全球监管提交文件，目标是使pirtobrutinib成为更广泛可能受益的患者群体的一种选择。

These data build on the previously reported positive results from the BRUIN Phase 1/2 trial, the Phase 3

这些数据基于此前报道的 BRUIN 1/2 期试验的积极结果，以及 3 期试验的结果，

BRUIN CLL-321

布鲁因 CLL-321

trial, the first randomized, controlled study ever conducted in an exclusively post-covalent BTK inhibitor population, and the Phase 3

试验，这是首个在完全后共价BTK抑制剂人群中进行的随机对照研究，以及第3阶段

BRUIN CLL-314

布鲁因CLL-314

trial, the first-ever head-to-head Phase 3 trial versus ibrutinib in CLL to include treatment-naïve patients. For more information on the BRUIN Phase 3 clinical trial program, please visit

试验，这是首个在CLL中与伊布替尼进行头对头比较的III期试验，并且包括了初治患者。有关BRUIN III期临床试验计划的更多信息，请访问

About BRUIN CLL-313

关于BRUIN CLL-313

BRUIN CLL-313 is a Phase 3, global, randomized, open-label study of pirtobrutinib versus chemoimmunotherapy (bendamustine plus rituximab) in people with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions who have not been previously treated. The trial enrolled 282 patients who were randomized 1:1 to receive pirtobrutinib (200 mg orally, once daily) or bendamustine plus rituximab (BR) per labeled doses.

BRUIN CLL-313 是一项 III 期、全球性、随机、开放标签的研究，比较了 pirtobrutinib 与化学免疫疗法（苯达莫司汀加利妥昔单抗）在未接受过治疗且无 17p 缺失的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。该试验招募了 282 名患者，以 1:1 的比例随机分配接受 pirtobrutinib（200 mg 口服，每日一次）或按标签剂量给予的苯达莫司汀加利妥昔单抗（BR）。

BR is a chemoimmunotherapy regimen used in the treatment of CLL. The primary endpoint is progression-free survival (PFS) as assessed by blinded independent review committee (IRC). Secondary endpoints include investigator and IRC assessed overall response rate (ORR), duration of response (DoR), and PFS, overall survival (OS), time to next treatment (TTNT), safety and tolerability and patient-reported outcomes (PRO).

BR是一种用于治疗CLL的化疗免疫疗法方案。主要终点是由盲态独立审查委员会（IRC）评估的无进展生存期（PFS）。次要终点包括研究者和IRC评估的总缓解率（ORR）、缓解持续时间（DoR）、PFS、总生存期（OS）、至下一次治疗的时间（TTNT）、安全性和耐受性以及患者报告的结果（PRO）。

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，前称 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。

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已验证分子靶点，包括套细胞淋巴瘤（MCL）和慢性淋巴细胞白血病（CLL）。

Jaypirca is a

Jaypirca 是一种

U.S.

美国

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.

FDA批准的口服处方药，每日一次200毫克剂量，可与食物同服或不同服，100毫克或50毫克片剂，直至疾病进展或出现不可接受的毒性。

About Lilly

关于礼来公司

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，我们一直在开创改变生命的发现，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；为一些最严重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 .

每朝着更健康的世界迈出一步，我们都被一个目标所驱动：让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。