BioLineRx宣布将在2025年ASCO年会上公布Motixafortide一线治疗胰腺癌（PDAC）的二期联合试验新试点阶段数据-动脉网

BioLineRx Announces New Pilot Phase Data from Phase 2 Combination Trial of Motixafortide in First-Line Pancreatic Cancer (PDAC) to be Presented at ASCO 2025 Annual Meeting

CISION 等信源发布 2025-05-30 19:00

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- 4 of 11 PDAC patients in the pilot phase remained progression free at over one year

- 在试点阶段，11名胰腺导管腺癌患者中有4名在一年多的时间里保持无进展

- Poster presentation on

- 海报展示

Saturday, May 31

5月31日，星期六

TEL AVIV, Israel

特拉维夫，以色列

，

May 30, 2025

2025年5月30日

/PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare disease, today announced that a poster including new data from the single-arm pilot phase of the investigator-initiated, randomized CheMo4METPANC Phase 2 combination clinical trial will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place .

/PRNewswire/ -- BioLineRx Ltd.（纳斯达克/特拉维夫证券交易所代码：BLRX），一家致力于开发肿瘤学和罕见病领域改变生命疗法的临床阶段生物制药公司，今日宣布，一张包含由研究者发起的随机CheMo4METPANC 2期联合临床试验单臂试点阶段新数据的海报，将在2025年美国临床肿瘤学会（ASCO）年会上展示，会议将于举行。

May 30-June 3, 2025

2025年5月30日-6月3日

在

Chicago, Illinois

伊利诺伊州芝加哥市

。

The CheMo4METPANC trial is evaluating the company's CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard-of-care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC).

CheMo4METPANC 试验正在评估该公司 CXCR4 抑制剂 motixafortide、PD-1 抑制剂 cemiplimab 以及标准治疗化疗药物吉西他滨和白蛋白结合型紫杉醇，与单独使用吉西他滨和白蛋白结合型紫杉醇在一线胰腺癌（PDAC）中的疗效。

Updated results from the pilot phase indicate that four of eleven patients remained progression free after more than one year. Two patients underwent definitive treatment for mPDAC: one had complete resolution of all radiologically detected liver lesions and underwent definitive radiation to the primary pancreatic tumor, and one had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrating a complete response.

试点阶段的更新结果显示，十一例患者中有四例在一年多的时间里病情未恶化。两名患者接受了针对mPDAC的最终治疗：一名患者所有通过影像学检测到的肝部病灶完全消失，并对原发胰腺肿瘤进行了最终放疗；另一名患者持续部分缓解，并接受了胰十二指肠切除术，病理结果显示完全缓解。

An analysis of pre- and on-treatment biopsies and peripheral blood mononuclear cells (PBMCs) also revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination. In addition, patients achieving a partial response were found to have higher pre-treatment proportions of CXCL12-producing cancer associated fibroblasts, a potential marker of response..

治疗前和治疗期间的活检以及外周血单核细胞 (PBMC) 分析还显示，所有十一名接受 motixafortide 联合治疗的患者中 CD8+ T 细胞肿瘤浸润均有所增加。此外，达到部分缓解的患者被发现治疗前产生 CXCL12 的癌相关成纤维细胞比例较高，这可能是反应的潜在标志物。

'The data that continue to emerge from the pilot phase of the CheMo4METPANC Phase 2 study are extremely encouraging, with four of eleven patients remaining progression free after more than one year, as well as two patients that underwent definitive treatment, in what has historically been among the most challenging tumor types to treat,' stated .

“CheMo4METPANC二期研究的试点阶段不断出现的数据非常令人鼓舞，11名患者中有4名在一年多后仍然无疾病进展，此外还有两名患者接受了根治性治疗。这种肿瘤类型历来是最难治疗的之一。”

Philip Serlin

菲利普·塞林

, Chief Executive Officer of BioLineRx Ltd. 'Notably, these results further suggest that the combination of motixafortide, cemiplimab and standard-of-care chemotherapy can overcome the immunosuppressive mechanisms of the tumor microenvironment (TME) and increase intratumoral CD8+ T-cell infiltration, resulting in improved patient outcomes.

BioLineRx Ltd.首席执行官。“值得注意的是，这些结果进一步表明，motixafortide、cemiplimab 和标准治疗化疗的组合可以克服肿瘤微环境 (TME) 的免疫抑制机制，增加肿瘤内 CD8+ T 细胞浸润，从而改善患者的预后。

We look forward to results from the ongoing randomized portion of this important study.' .

我们期待这项重要研究正在进行的随机部分的结果。

The pilot clinical trial of motixafortide, cemiplimab, gemcitabine and nab-paclitaxel (N=11) demonstrated an overall response rate (ORR) of 64% (7/11) and a disease control rate (DCR) of 91% (10/11), compared to historical ORR and DCR of 23% and 48%, respectively, with gemcitabine and nab-paclitaxel.

motixafortide、cemiplimab、吉西他滨和nab-紫杉醇（N=11）的试点临床试验显示，总体缓解率（ORR）为64%（7/11），疾病控制率（DCR）为91%（10/11），而历史上吉西他滨和nab-紫杉醇的ORR和DCR分别为23%和48%。

Based on these encouraging results, the CheMo4METPANC Phase 2 trial was amended to become a randomized study, with planned enrollment increasing from 30 to 108 patients. The trial is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies.

基于这些令人鼓舞的结果，CheMo4METPANC 二期试验进行了修改，成为一项随机研究，计划入组人数从30人增加到108人。该试验是首个大型、多中心、随机研究，评估了motixafortide联合PD-1抑制剂和一线PDAC化疗的效果。

The trial is planned to be fully enrolled in 2027, and a prespecified interim analysis is planned for when 40% of PFS events are observed..

该试验计划于2027年完成全部入组，并在观察到40%的无进展生存事件时进行预先设定的中期分析。

Poster Presentation at ASCO 2025

2025年ASCO海报展示

McCormick Place, Chicago,

麦考密克会展中心，芝加哥，

Illinois

伊利诺伊州

Poster Session Details

海报会议详情

Primary Track:

主轨道：

Gastrointestinal Cancer—Gastroesophageal, Pancreatic and Hepatobiliary

胃肠道癌症——胃食管、胰腺和肝胆

Title:

标题：

CheMo4METPANC: Combination Chemotherapy (Gemcitabine and Nab-Paclitaxel), Chemokine (C-X-C) Motif Receptor 4 Inhibitor (Motixafortide), and Immune Checkpoint Blockade (Cemiplimab) in Metastatic Treatment-Naïve Pancreatic Adenocarcinoma

CheMo4METPANC：联合化疗（吉西他滨和白蛋白结合型紫杉醇）、趋化因子（C-X-C）基序受体4抑制剂（Motixafortide）以及免疫检查点阻断剂（Cemiplimab）用于转移性初治胰腺腺癌

Presenter:

主持人：

Gulam Abbas Manji, MD, PhD, Columbia University Herbert Irving Comprehensive Cancer Center

古拉姆·阿巴斯·曼吉，医学博士，哲学博士，哥伦比亚大学赫伯特·欧文综合癌症中心

Abstract:

摘要：

4167

Poster Bd #:

海报 Bd 编号：

457

Date:

日期：

May 31, 2025

2025年5月31日

Time:

时间：

9:00am CDT

上午9:00（中部夏令时间）

Location:

位置：

Hall A

大厅A

About CheMo4METPANC Phase 2 Clinical Trial

关于CheMo4METPANC二期临床试验

The multi-center CheMo4METPANC Phase 2 clinical trial (

多中心CheMo4METPANC二期临床试验 (

ClinicalTrials.gov

临床试验.gov

Identifier:

标识符：

NCT04543071

) is a randomized, investigator-initiated clinical trial in first line metastatic pancreatic cancer. Sponsored by Columbia University, and supported equally by BioLineRx and Regeneron, the study is evaluating the combination of CXCR4 inhibitor motixafortide, PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in 108 patients.

）是一项由研究者发起的随机临床试验，针对一线转移性胰腺癌。该研究由哥伦比亚大学赞助，BioLineRx和Regeneron平等支持，正在评估CXCR4抑制剂motixafortide、PD-1抑制剂cemiplimab与标准治疗化疗药物吉西他滨和nab-紫杉醇联合使用，与单独使用吉西他滨和nab-紫杉醇的效果，共纳入108名患者。

The trial's primary endpoint is progression free survival (PFS). Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival..

该试验的主要终点是无进展生存期 (PFS)。次要目标包括安全性、缓解率、疾病控制率、临床获益持续时间和总生存期。

About Pancreatic Cancer

关于胰腺癌

Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. In the United States in 2024, an estimated 66,000 adults will be diagnosed with the disease, which accounts for approximately 3% of all cancers in the U.S. and about 7% of all cancer deaths.

胰腺癌的早期诊断率低，预后较差。据估计，在2024年，美国将有约66,000名成年人被诊断出患有该疾病，这约占美国所有癌症的3%，以及所有癌症死亡人数的7%左右。

Worldwide, an estimated 496,000 people were diagnosed with the disease in 2020. In the U.S., if the cancer is detected at an early stage when surgical removal of the tumor is possible, the 5-year relative survival rate is 44%. About 12% of people are initially diagnosed at this stage. If the cancer has spread to surrounding tissues or organs, the 5-year relative survival rate is 15%. For the 52% of patients who are initially diagnosed with metastatic cancer, the 5-year relative survival rate is 3%..

在全球范围内，2020年约有496,000人被诊断出患有该疾病。在美国，如果癌症在早期阶段被发现，且可以通过手术切除肿瘤，那么5年相对生存率为44%。大约12%的患者最初被诊断为此阶段。如果癌症已经扩散到周围组织或器官，5年相对生存率为15%。对于最初被诊断为转移性癌症的52%患者，5年相对生存率仅为3%。

In particular, hepatic (liver) metastases are a critical risk factor driving poor prognoses for patients with metastatic PDAC. These data highlight the need for the development of new therapeutic options.

特别是，肝（肝脏）转移是导致转移性胰腺导管腺癌患者预后不良的关键风险因素。这些数据突显了开发新治疗方案的必要性。

About Motixafortide in Cancer Immunotherapy

关于Motixafortide在癌症免疫治疗中的应用

Motixafortide inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC). Motixafortide leverages the expression of the CXCR4 receptor on different immune cells and potentiates the immune system against the tumor.

Motixafortide抑制CXCR4，这是一种趋化因子受体，也是一个在许多人类癌症中过度表达的、经过充分验证的治疗靶点，包括胰腺导管腺癌（PDAC）。Motixafortide利用CXCR4受体在不同免疫细胞上的表达，增强免疫系统对肿瘤的攻击。

Among CXCR4-expressing immune cells, some exhibit anti-tumoral activity, such as effector T cells and some exhibit pro-tumoral activity and support tumor growth. By blocking the CXCR4 receptor, motixafortide was shown in a Phase 2 study in pancreatic cancer patients to enhance anti-tumoral activity and to ameliorate the pro-tumoral activities by modulating the effector/suppressor cell ratio towards a proinflammatory profile..

在表达CXCR4的免疫细胞中，一些表现出抗肿瘤活性，如效应T细胞，而另一些则表现出促肿瘤活性并支持肿瘤生长。通过阻断CXCR4受体，在胰腺癌患者的2期研究中，motixafortide被证明可以增强抗肿瘤活性，并通过调节效应/抑制细胞比例为促炎特性来改善促肿瘤活动。

About BioLineRx

关于BioLineRx

BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a biopharmaceutical company pursuing life-changing therapies in oncology and rare disease. The Company's first approved product is APHEXDA® (motixafortide), with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma, which is being developed and commercialized by Ayrmid Ltd.

BioLineRx Ltd.（纳斯达克/特拉维夫证券交易所代码：BLRX）是一家生物医药公司，专注于在肿瘤学和罕见病领域开发改变生命的疗法。该公司首个获批产品是APHEXDA®（motixafortide），在美国用于多发性骨髓瘤自体移植的干细胞动员，该产品由Ayrmid Ltd.负责开发和商业化。

(globally, excluding .

（全球范围内，排除。

Asia

亚洲

) and Gloria Biosciences (in

）和格洛丽亚生物科学（在

Asia

亚洲

). BioLineRx is utilizing its end-to-end expertise in development, regulatory affairs and manufacturing to advance its innovative pipeline and ensure life-changing discoveries move beyond the bench to the bedside.

). BioLineRx 利用其在开发、法规事务和制造方面的端到端专业知识，推进其创新的研发管线，并确保改变生命的发现从实验室走向临床。

Learn more about who we are, what we do, and how we do it at

了解更多关于我们是谁、我们做什么以及我们如何做的信息，请访问

www.biolinerx.com

, or on

，或者在

Twitter

推特

and

和

领英

。

Forward Looking Statement

前瞻性声明

Various statements in this release concerning BioLineRx's future expectations constitute 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as 'anticipates,' 'believes,' 'could,' 'estimates,' 'expects,' 'intends,' 'may,' 'plans,' 'potential,' 'predicts,' 'projects,' 'should,' 'will,' and 'would,' and describe opinions about future events.

本发布中有关BioLineRx未来预期的各种声明构成了1995年《私人证券诉讼改革法》所指的“前瞻性声明”。这些声明包括诸如“预期”、“相信”、“可能”、“估计”、“预计”、“打算”、“或许”、“计划”、“潜在”、“预测”、“预计”、“应该”、“将”和“会”等词汇，并描述了对未来事件的看法。

These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the potential success of the license agreement with Ayrmid and the commercial potential of motixafortide, expectations with regard to clinical trials of motixafortide, the expected cash runway, and BioLineRx's business strategy.

这些声明包括管理层对以下事项的预期、信念和意图：与Ayrmid的许可协议的潜在成功及motixafortide的商业潜力、对motixafortide临床试验的预期、预期的现金跑道以及BioLineRx的业务战略。

These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.

这些前瞻性陈述涉及已知和未知的风险、不确定性以及其他可能导致BioLineRx的实际结果、业绩或成就与这些前瞻性陈述明示或暗示的任何未来结果、业绩或成就存在重大差异的因素。

Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials, and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its precl.

可能导致BioLineRx的实际结果与这些前瞻性陈述中明示或暗示的内容存在重大差异的因素包括但不限于：BioLineRx治疗候选药物的临床开发、商业化及市场接受度，包括APHEXDA在多发性骨髓瘤患者中动员造血干细胞用于自体移植的市场接受程度和速度；BioLineRx的临床前研究、临床试验及其他治疗候选药物开发工作的启动、时间安排、进展和结果；BioLineRx将其治疗候选药物推进到临床试验或成功完成其临床前研究的能力。

the United States

美国

or elsewhere; competitive companies, technologies and BioLineRx's industry; BioLineRx's ability to maintain the listing of its ADSs on Nasdaq; and statements as to the impact of the political and security situation in

或在其他地方；竞争公司、技术和BioLineRx的行业；BioLineRx维持其美国存托股份在纳斯达克上市的能力；以及关于政治和安全局势影响的声明。

Israel

以色列

on BioLineRx's business, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the 'Risk Factors' section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on

可能加剧上述因素对BioLineRx业务的影响。这些及其他因素在BioLineRx最近提交给美国证券交易委员会的20-F表格年度报告的“风险因素”部分中有更详细的讨论。

March 31, 2025

2025年3月31日

. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

此外，任何前瞻性声明仅代表BioLineRx在本发布日期的观点，不应被视为代表其在任何后续日期的观点。除非法律要求，BioLineRx不承担更新任何前瞻性声明的义务。

Contacts:

联系人：

United States

美国

Irina Koffler

伊琳娜·科夫勒

LifeSci Advisors, LLC

生命科学顾问有限公司

IR@biolinerx.com

Israel

以色列