百时美施贵宝宣布两项早期研究结果，评估潜在一流CELMoD™药物Golcadomide在非霍奇金淋巴瘤患者中的疗效-动脉网

Two Early Studies Evaluating Potential First-in-Class CELMoD™ Agent Golcadomide for the Treatment of Non-Hodgkin Lymphomas Presented at ASH 2023

BioSpace 等信源发布 2023-12-12 14:37



可切换为仅中文







Phase 1b DLBCL-001 study reinforces promising activity and combinability of golcadomide with R-CHOP in patients with previously untreated aggressive B-cell lymphoma

1b期DLBCL-001研究增强了戈尔卡多米与R-CHOP在先前未经治疗的侵袭性B细胞淋巴瘤患者中的有希望的活性和可组合性

Phase 1/2 CC-99282-NHL-001 study demonstrates activity and combinability with rituximab in heavily pretreated patients with diffuse large B-cell lymphoma

1/2期CC-99282-NHL-001研究表明，在经过严重预处理的弥漫性大B细胞淋巴瘤患者中，利妥昔单抗具有活性和可组合性

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) announced the results of two early studies evaluating combinations of potential first-in-class CELMoD™ agent golcadomide in non-Hodgkin lymphomas. These data are being presented in separate posters (#4459, #4496, #1631) at the 2023 American Society of Hematology (ASH) Annual Meeting from December 9-12..

普林斯顿，新泽西州--（商业新闻短讯）--百时美施贵宝（纽约证券交易所：BMY）宣布了两项早期研究的结果，这些研究评估了潜在的一流CELMoD组合™非霍奇金淋巴瘤中的药物戈尔卡多米。这些数据将在12月9日至12日举行的2023年美国血液学会（ASH）年会上以单独的海报（#4459，#4496，#1631）呈现。。

“Golcadomide is a novel, oral CELMoD agent representing one of several compelling assets generated from our differentiated targeted protein degradation research platform,” said Michael Pourdehnad, M.D., senior vice president, Head of Early Clinical Development, Hematology, Oncology and Cell Therapy Development, Bristol Myers Squibb.

百时美施贵宝高级副总裁、早期临床开发、血液学、肿瘤学和细胞疗法开发负责人迈克尔·波尔德纳德（Michael Pourdehnad）医学博士说：“戈尔卡多米是一种新型口服CELMoD药物，代表了我们差异化靶向蛋白质降解研究平台产生的几种引人注目的资产之一。”。

“In the studies being presented at ASH 2023, golcadomide has shown potential warranting further evaluation in patients with first-line and previously treated large B-cell lymphomas. We are encouraged by the growing body of evidence for this purposefully designed lymphoma agent as we continue toward a registrational program.”.

“在ASH 2023上提交的研究中，戈尔卡多米显示出对一线和先前治疗过的大B细胞淋巴瘤患者进行进一步评估的潜力。随着我们继续进行注册计划，越来越多的证据表明这种有目的设计的淋巴瘤药物，我们感到鼓舞。”。

CC-220-DLBCL-001

In the dose expansion phase of this Phase 1b study, patients were randomized 1:1 to golcadomide at one of two recommended Phase 2 dose levels (DL) (DL-1: 0.2 mg day 1-7, n=35; DL1: 0.4 mg day 1-7, n=37) plus R-CHOP-21 for a fixed duration of 6 cycles. A total of 65 (83.3%) patients completed 6 cycles of the combination with 13 discontinuing treatment..

在这项1b期研究的剂量扩展阶段，患者以两种推荐的2期剂量水平（DL）之一（DL-1:0.2 mg第1-7天，n=35；DL1:0.4 mg第1-7天，n=37）加上R-CHOP-21，固定持续6个周期。共有65名（83.3%）患者完成了6个周期的联合治疗，其中13名停止治疗。。

There were 71 patients evaluable for efficacy, and results showed:

有71名患者可评估疗效，结果显示：

Overall response rate (ORR) at end of treatment rate was 84.5% in patients overall, with 87.9% of patients in the DL1 arm achieving a complete metabolic response (CMR) compared to 63.6% in the DL-1 arm.

治疗结束时的总有效率（ORR）总体上为84.5%，DL1组中87.9%的患者达到完全代谢反应（CMR），而DL-1组为63.6%。

Minimal residual disease negativity at the end of treatment was achieved in 93% (14/15) of patients treated with 0.4 mg of golcadomide plus R-CHOP compared to 70% (7/10) treated with 0.2 mg of golcadomide plus R-CHOP.

93%（14/15）接受0.4 mg戈尔卡多胺加R-CHOP治疗的患者在治疗结束时达到最小残留疾病阴性，而70%（7/10）接受0.2 mg戈尔卡多胺加R-CHOP治疗。

At both DL1 and DL-1, steady-state levels of golcadomide reduced Ikaros over 80%, to levels predicted to optimize tumor cell killing and to stimulate T and NK cells.

在DL1和DL-1中，戈尔卡多米的稳态水平将Ikaros降低了80%以上，达到了预测可优化肿瘤细胞杀伤并刺激T细胞和NK细胞的水平。

In the safety population (n=78), the majority of patients (98.7%) experienced at least one treatment-emergent adverse event (TEAE). Grade 3/4 TEAEs were primarily hematologic with neutropenia (89.7%), thrombocytopenia (42.3%) and anemia (32.1%) being the most common. Any grade febrile neutropenia was reported in 21.8% of patients.

在安全人群（n=78）中，大多数患者（98.7%）经历了至少一次治疗紧急不良事件（TEAE）。3/4级TEAE主要是血液学，中性粒细胞减少（89.7%），血小板减少（42.3%）和贫血（32.1%）是最常见的。21.8%的患者报告有任何程度的发热性中性粒细胞减少症。

Median relative dose intensity of key R-CHOP components was maintained at >90%..

关键R-CHOP成分的中位相对剂量强度维持在>90%。。

CC-99282-NHL-001

A separate poster detailed the efficacy and safety results from the dose expansion segment of a Phase 1/2 open-label study of two doses of golcadomide (0.2 mg, 0.4 mg) plus rituximab in relapsed/refractory patients with non-Hodgkin lymphoma. Patients were heavily pre-treated with a median number of 4 prior therapies (range 1-11), including 61% who had prior CAR T..

另一张海报详细介绍了两种剂量的戈尔卡多米（0.2 mg，0.4 mg）加利妥昔单抗治疗复发/难治性非霍奇金淋巴瘤患者的1/2期开放标签研究的剂量扩展部分的疗效和安全性结果。患者接受了4次先前治疗的中位数（范围1-11）的严重预处理，其中61%的患者曾接受过CAR T。。

In patients evaluable for efficacy (n=26), the ORR was 42% (11/26) with 19% (5/26) achieving a complete response (CR). The median duration of response was 7.5 months (1.8-14.5). The ORR and CR rate was greater for patients in the 0.4 mg arm compared to the 0.2 arm (55% vs. 33% and 27% vs. 13%, respectively)..

在可评估疗效的患者（n=26）中，ORR为42%（11/26），其中19%（5/26）达到完全缓解（CR）。中位缓解时间为7.5个月（1.8-14.5）。与0.2组相比，0.4 mg组患者的ORR和CR率更高（分别为55%比33%和27%比13%）。。

In the study, neutropenia was the most common TEAE of any grade, occurring in 50% of patients (22/44). Febrile neutropenia was observed in 2 patients, with 1 patient at each dose level. A total of 6 patients had serious adverse events with only pneumonia and pyrexia occurring in more than 1 patient (2 each).

在该研究中，中性粒细胞减少症是任何级别中最常见的TEAE，发生率为50%（22/44）。在2名患者中观察到发热性中性粒细胞减少症，每个剂量水平有1名患者。共有6名患者发生严重不良事件，超过1名患者（各2名）仅发生肺炎和发热。

There were 4 deaths on treatment during the study with one considered related to the study treatment..

在研究期间，有4人在治疗中死亡，其中一人被认为与研究治疗有关。。

About Non-Hodgkin Lymphoma and Large B-Cell Lymphoma

关于非霍奇金淋巴瘤和大B细胞淋巴瘤

Non-Hodgkin lymphoma (NHL) is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system.1 Diffuse large B-cell lymphoma (DLBCL) is a rapidly growing, aggressive disease and the most common form of non-Hodgkin lymphoma (NHL), accounting for one out of every three cases diagnosed.2 More than two-thirds of patients with DLBCL will not respond to or will relapse following second-line treatment.

非霍奇金淋巴瘤（NHL）是一种始于称为淋巴细胞的白细胞的癌症，淋巴细胞是人体免疫系统的一部分。1弥漫性大B细胞淋巴瘤（DLBCL）是一种快速增长的侵袭性疾病，也是最常见的非霍奇金淋巴瘤（NHL），占确诊病例的三分之一。超过三分之二的DLBCL患者在二线治疗后不会反应或复发。

For patients who relapse or do not respond to initial therapies, conventional treatment options that provide durable remission are limited and median life expectancy is about six months, leaving a critical need for new therapies.3,4.

对于复发或对初始治疗无反应的患者，提供持久缓解的常规治疗选择是有限的，中位预期寿命约为6个月，因此迫切需要新的治疗方法[3,4]。

Bristol Myers Squibb: Creating a Better Future for People with Cancer

百时美施贵宝：为癌症患者创造更美好的未来

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus.

百时美施贵宝的灵感来自一个单一的愿景——通过科学改变患者的生活。该公司癌症研究的目标是提供药物，为每位患者提供更好、更健康的生活，并使治愈成为可能。百时美施贵宝（Bristol-Myers Squibb）的研究人员正在探索个性化医学的新前沿，并通过创新的数字平台，将数据转化为见解，从而提高他们的关注度。

Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle..

对因果人类生物学的深刻理解、尖端能力和差异化研究平台使该公司能够从各个角度处理癌症。。

Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future..

癌症可以无情地影响患者生活的许多方面，百时美施贵宝致力于采取行动解决护理的各个方面，从诊断到生存。作为癌症治疗领域的领导者，百时美施贵宝正在努力让所有癌症患者拥有更好的未来。。

About Bristol Myers Squibb

关于百时美施贵宝

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram..

百时美施贵宝是一家全球生物制药公司，其使命是发现、开发和提供创新药物，帮助患者战胜严重疾病。有关百时美施贵宝的更多信息，请访问BMS.com或在LinkedIn、Twitter、YouTube、Facebook和Instagram上关注我们。。

Cautionary Statement Regarding Forward-Looking Statements

关于前瞻性声明的警示声明

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的“前瞻性声明”，其中涉及药品的研究、开发和商业化。所有不属于历史事实陈述的陈述都是或可能被视为前瞻性陈述。

Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements.

此类前瞻性陈述基于对我们未来财务业绩、目标、计划和目标的当前预期和预测，涉及固有风险、假设和不确定性，包括可能在未来几年延迟、转移或改变其中任何一个的难以预测的内部或外部因素，可能超出我们的控制范围，并可能导致我们未来的财务结果、目标、计划和目标与报表中表达或暗示的财务结果、目标、计划和目标存在重大差异。

These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that the product candidates described in this release may not receive regulatory approval for the indications described in this release, that any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such product candidates for such indications will be commercially successful.

这些风险、假设、不确定性和其他因素包括，未来的研究结果可能与迄今为止的结果不一致，本版本中描述的候选产品可能未获得本版本中描述的适应症的监管批准，任何营销批准（如果授予）可能对其使用有重大限制，如果获得批准，这些适应症的候选产品是否会取得商业成功。

No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2022, as updated by our subsequent Quarterl.

不能保证前瞻性声明。本新闻稿中的前瞻性陈述应与影响百时美施贵宝业务和市场的许多风险和不确定性一起进行评估，特别是在百时美施贵宝截至2022年12月31日的年度报告10-K表中的警示声明和风险因素讨论中确定的风险和不确定性，并由我们随后的季度更新。

References

参考文献

American Cancer Society. What is non-Hodgkin lymphoma? Available at: https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/what-is-non-hodgkin-lymphoma.html. Accessed November 2023.

美国癌症协会。什么是非霍奇金淋巴瘤？网址：https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/what-is-non-hodgkin-lymphoma.html.2023年11月访问。

American Cancer Society. Types of B cell lymphoma. Available at: https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/b-cell-lymphoma.html. Accessed March 2022.

美国癌症协会。B细胞淋巴瘤的类型。网址：https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/b-cell-lymphoma.html.2022年3月访问。

Crump M, Neelapu SS, Farooq U et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017; 130(16): 1800-1808.

Crump M，Neelapu SS，Farooq U等。难治性弥漫性大B细胞淋巴瘤的结果：国际学者-1研究的结果。血。2017年；130（16）：1800-1808。

Raut LS, Chakrabarti PP. Management of relapsed-refractory diffuse large B cell lymphoma. South Asian J Can. 2014; 3(1): 66-70.

Raut LS，Chakrabarti PP。复发难治性弥漫性大B细胞淋巴瘤的治疗。南亚J Can。2014年；3（1）：66-70。

corporatefinancial-news

企业财经新闻

View source version on businesswire.com: https://www.businesswire.com/news/home/20231210559794/en/

在businesswire.com上查看源版本：https://www.businesswire.com/news/home/20231210559794/en/

Contacts

联系人

Bristol Myers Squibb

百时美施贵宝

Media Inquiries: