Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib, in combination with anti-PD-1 therapy KEYTRUDA (pembrolizumab), for the first-line treatment of patients with unresectable advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation and PD-L1 expression ≥ 50%, as determined by FDA approved tests. Olomorasib is a potent and highly selective second-generation inhibitor of KRAS G12C with preliminary evidence of central nervous system (CNS) activity.

礼来公司（纽约证券交易所代码：LLY）今天宣布，美国食品和药物管理局 （FDA） 已授予奥洛莫拉西突破性疗法称号，与抗 PD-1 疗法 KEYTRUDA（派姆单抗）联合使用，用于一线治疗具有 KRAS 的不可切除晚期或转移性非小细胞肺癌 （NSCLC） 患者G12C 突变和 PD-L1 表达≥ 50%，由 FDA 批准的测试确定。奥洛莫拉西是一种有效且高选择性的第二代 KRAS G12C 抑制剂，具有中枢神经系统 （CNS） 活性的初步证据。

Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies that have received full FDA approval..

突破性疗法指定旨在加速用于治疗严重疾病的药物的开发和审查，当初步临床证据表明该药物可能在临床上重要的终点上比已经获得完全FDA批准的现有疗法显示出显著改善时。

'The Breakthrough Therapy designation recognizes the potential for olomorasib to be a meaningful treatment advance and highlights the continued unmet need for improved options for patients with

“突破性疗法认定认可了olomorasib成为一项有意义的治疗进展的潜力，并突显了对改善患者选择方案的持续未满足需求。

KRAS

KRAS

G12C-mutant NSCLC, particularly in the first-line setting in combination with standard-of-care immunotherapy,' said

G12C突变型非小细胞肺癌，特别是在一线环境中与标准治疗免疫疗法联合使用时，

David Hyman

大卫·海曼

, M.D., Lilly chief medical officer. 'We look forward to presenting updated data from the olomorasib development program in significantly more patients and with longer follow-up at WCLC and continuing to investigate olomorasib in combination with immunotherapy-based regimens in a variety of treatment settings across the Phase 3 SUNRAY-01 and SUNRAY-02 studies.'.

，医学博士，礼来首席医疗官。“我们期待在世界肺癌大会上展示奥莫拉西布开发项目中更多患者及更长随访期的更新数据，并继续在三期SUNRAY-01和SUNRAY-02研究中探索奥莫拉西布与基于免疫疗法的联合方案在各种治疗环境中的应用。”

The FDA Breakthrough Therapy designation is based on encouraging results from the Phase 1/2 LOXO-RAS-20001 trial and the dose optimization portion of the Phase 3 SUNRAY-01 trial. Updated results from an integrated analysis from these studies will be presented at the 2025

FDA突破性疗法认定是基于1/2期LOXO-RAS-20001试验的鼓舞人心的结果以及3期SUNRAY-01试验的剂量优化部分。这些研究的综合分析的最新结果将在2025年公布。

World Conference on Lung Cancer

世界肺癌大会

(WCLC) hosted by the

（WCLC）主办的

International Association for the Study of Lung Cancer

国际肺癌研究协会

(IASLC), taking place

（IASLC），正在举行

Sept. 6 - 9

9月6日 - 9日

in

在

Barcelona, Spain

西班牙巴塞罗那

.

。

Details on Presentations at the IASLC 2025

2025年IASLC演讲详情

World Conference on Lung Cancer

世界肺癌大会

In an oral presentation (

在口头报告中 (

Abstract #MA02.06

摘要 #MA02.06

), Lilly will report on an integrated analysis of efficacy and safety results in patients with

），礼来公司将报告对患者疗效和安全性结果的综合分析，这些患者包括

KRAS

KRAS

G12C-mutant NSCLC who received olomorasib plus pembrolizumab as first-line treatment in the dose optimization cohorts of the Phase 1/2 LOXO-RAS-20001 study and Phase 3 SUNRAY-01 study. These data will be shared in an oral presentation during the New Treatment Strategies in Other Than EGFR-Positive Tumors session on .

在1/2期LOXO-RAS-20001研究和3期SUNRAY-01研究的剂量优化队列中，接受奥莫拉西布联合帕博利珠单抗作为一线治疗的G12C突变型非小细胞肺癌患者。这些数据将在非EGFR阳性肿瘤的新治疗策略会议期间的口头报告中分享。

Sunday, Sept. 7, 2025

2025年9月7日，星期日

, from

，来自

12-1:15 p.m.

12点到下午1点15分

Central European

中欧的

Summer Time

夏日时光

(CEST).

（欧洲中部夏令时间）。

In a second oral presentation (

在第二次口头报告中（

Abstract #OA08.02

摘要 #OA08.02

), Lilly will report results of an integrated analysis in patients with

），礼来公司将报告针对以下患者的整体分析结果：

KRAS

KRAS

G12C-mutant advanced or metastatic NSCLC who received olomorasib in combination with chemoimmunotherapy (pembrolizumab, pemetrexed and platinum) as a first-line treatment in the Phase 1/2 LOXO-RAS-20001 trial and safety lead-in for the Phase 3 SUNRAY-01 trial. These data will be shared in an oral presentation during the Improving Outcomes in EGFR and KRAS Mutant Tumors, More is Better session on .

在1/2期LOXO-RAS-20001试验以及3期SUNRAY-01试验的安全性导入阶段中，接受奥莫拉西布联合化疗免疫疗法（帕博利珠单抗、培美曲塞和铂类）作为一线治疗的G12C突变晚期或转移性非小细胞肺癌患者。这些数据将在“改善EGFR和KRAS突变肿瘤的治疗结果，越多越好”会议期间的口头报告中分享。

Monday, Sept. 8, 2025

2025年9月8日，星期一

, from

，来自

12-1:15 p.m. CEST

12-1:15 下午 CEST

The submitted abstracts for both presentations utilized a

提交的两份演示摘要均使用了

Jan. 15, 2025

2025年1月15日

data cut-off date, and the oral presentations will utilize a

数据截止日期，口头报告将使用一个

June 6, 2025

2025年6月6日

data cut-off date.

数据截止日期。

About LOXO-RAS-20001

关于LOXO-RAS-20001

LOXO-RAS-20001 is an open-label, multicenter, Phase 1/2 study evaluating the safety, tolerability and preliminary efficacy of olomorasib in patients with

LOXO-RAS-20001是一项开放标签、多中心的1/2期研究，评估了olomorasib在患者中的安全性、耐受性和初步疗效。

KRAS

KRAS

G12C-mutant advanced solid tumors (

G12C突变的晚期实体瘤 (

NCT04956640

NCT04956640

). The study includes a Phase 1a dose escalation phase of olomorasib monotherapy in

). 该研究包括奥洛莫司单药治疗的 Phase 1a 剂量递增阶段，

KRAS

KRAS

G12C

G12C

mutant solid tumors and a Phase 1b dose expansion and optimization phase which are evaluating olomorasib as a monotherapy and in combination with other treatments.

突变型实体瘤以及一项1b期剂量扩展和优化阶段，这些研究正在评估奥莫拉西布作为单一疗法以及与其它治疗方法联合使用的效果。

About SUNRAY-01

关于SUNRAY-01

SUNRAY-01 is a randomized, double-blind, placebo-controlled, global Phase 3 study evaluating the efficacy and safety of olomorasib in combination with pembrolizumab with or without chemotherapy as a first-line treatment for patients with

SUNRAY-01是一项随机、双盲、安慰剂对照的全球III期研究，评估奥莫拉西布联合帕博利珠单抗加或不加化疗作为一线治疗方案在患者中的疗效和安全性。

KRAS

KRAS

G12C-mutant metastatic non-small cell lung cancer (NSCLC). The trial is designed to compare olomorasib plus standard-of-care therapies versus placebo plus standard-of-care therapies, with the goal of determining whether the addition of olomorasib can improve clinical outcomes in this patient population.

G12C突变型转移性非小细胞肺癌（NSCLC）。该试验旨在比较奥莫拉西布联合标准治疗与安慰剂联合标准治疗，目的是确定添加奥莫拉西布是否可以改善该患者群体的临床结果。

SUNRAY-01 is part of Lilly's broader clinical development program investigating olomorasib across multiple stages and settings of .

SUNRAY-01 是 Lilly 更广泛的临床开发计划的一部分，该计划正在多个阶段和环境中研究 olomorasib。

KRAS

KRAS

G12C-mutant NSCLC (

G12C突变型非小细胞肺癌 (

NCT06890598

NCT06890598

About Olomorasib

关于Olomorasib

Olomorasib (LY3537982) is an investigational, oral, potent, and highly selective second-generation inhibitor of the KRAS G12C protein. KRAS is the most common oncogene across all tumor types, and

奥洛莫西布 (LY3537982) 是一种研究性、口服、强效且高度选择性的第二代 KRAS G12C 蛋白抑制剂。KRAS 是所有肿瘤类型中最常见的致癌基因，而且

KRAS

KRAS

G12C mutations occur in 13% of patients with non-small cell lung cancer (NSCLC), and 1-3% of patients with other solid tumors.

G12C突变发生在13%的非小细胞肺癌（NSCLC）患者中，以及1-3%的其他实体瘤患者中。

Olomorasib is a highly potent covalent inhibitor with potential for greater than 90% target occupancy, which may allow for safer combinations with less toxicity.

奥洛莫司是一种高效的共价抑制剂，具有超过90%靶点占有率的潜力，这可能使其与更低毒性的更安全组合成为可能。

Olomorasib is currently being studied in

奥洛莫司ib目前正在研究中

KRAS

KRAS

G12C-mutated cancers in combination with pembrolizumab with or without chemotherapy for first-line treatment of advanced NSCLC,  in combination with immunotherapy for the treatment of resected and unresectable NSCLC, and as monotherapy and in combinations in other advanced solid tumors, including:

G12C突变癌症与pembrolizumab联合使用，无论是否结合化疗，用于晚期非小细胞肺癌（NSCLC）的一线治疗；与免疫疗法联合用于可切除和不可切除的非小细胞肺癌的治疗；并作为单药或与其他药物联合用于其他晚期实体瘤的治疗，包括：

About Lilly

关于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.

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变为可管理的疾病。