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百时美施贵宝分公司在多发性骨髓瘤患者中的三期临床结果取得进展,势头强劲

Bristol Myers Squibb Franchise Gains Momentum With Phase 3 Results In Multiple Myeloma Patients

benzinga 等信源发布 2025-09-23 13:07

可切换为仅中文


Bristol Myers Squibb & Co.

百时美施贵宝公司

BMY

百时美施贵宝

on Tuesday announced results from the Phase 3 EXCALIBER-RRMM study evaluating iberdomide, an investigational cereblon E3 ligase modulator (CELMoD), combined with standard therapies (daratumumab + dexamethasone) in patients with relapsed or

周二公布了评估伊贝多胺(一种研究中的 cereblon E3 连接酶调节剂 (CELMoD))联合标准疗法(达拉图单抗 + 地塞米松)用于复发或难治性多发性骨髓瘤患者的 3 期 EXCALIBER-RRMM 研究的结果。

refractory multiple myeloma (RRMM)

复发难治性多发性骨髓瘤 (RRMM)

.

The trial demonstrated a statistically significant improvement in minimal residual disease (MRD) negativity rates, compared with the control arm, in a planned interim

与对照组相比,该试验在计划的中期分析中显示了微小残留病(MRD)阴性率的统计学显著改善。

analysis of the MRD endpoint

MRD终点分析

.

In accordance with the trial design and based on the recommendation from the Data Monitoring Committee, the trial will continue without changes to evaluate the other dual-primary endpoint of progression-free survival (PFS), and the key secondary endpoint of overall survival and safety.

根据试验设计,并基于数据监查委员会的建议,试验将继续进行,且不作任何更改,以评估无进展生存期(PFS)的另一主要终点,以及总生存期和安全性的关键次要终点。

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The safety profile of iberdomide in combination with daratumumab and dexamethasone in this study is generally consistent with previous studies.

本研究中,iberdomide联合daratumumab和地塞米松的安全性特征与之前的研究大体一致。

Bristol Myers Squibb plans to discuss these results with health authorities.

百时美施贵宝计划就这些结果与卫生当局进行讨论。

William Blair on Monday said, “As the first Phase III readout for the CELMoD franchise, the initial MRD results for EXCALIBER-RRMM represent a clear win, and we look forward to upcoming PFS data, which will definitively establish the trial's success.”

威廉·布莱尔周一表示:“作为CELMoD产品线的首个三期试验数据,EXCALIBER-RRMM 的初始 MRD 结果无疑是一次明确的成功,我们期待即将公布的 PFS 数据,这将最终确立该试验的成功。”

Analyst Matt Phipps said the most critical CELMoD data will come from head-to-head trials against Revlimid and Pomalyst (EXCALIBER-Maintenance, SUCCESSOR-1, GOLSEEK-4), as these are key to driving the IMiD franchise transition while generics erode sales of the older drugs.

分析师马特·菲普斯表示,最关键的 CELMoD 数据将来自与 Revlimid 和 Pomalyst 的头对头试验(EXCALIBER-Maintenance、SUCCESSOR-1、GOLSEEK-4),因为这些数据对于推动 IMiD 专营权过渡至关重要,同时仿制药正在侵蚀这些老药的销售额。

William Blair views CELMoDs as one of the company's most important Phase 3 programs. Combined with late-stage assets like milvexian and the ongoing launch of Cobenfy for schizophrenia, these could support the company's long-term growth.

威廉·布莱尔认为,CELMoDs 是该公司最重要的三期项目之一。结合 milvexian 等晚期资产以及 Cobenfy 在精神分裂症领域的持续推出,这些可能为公司的长期增长提供支持。

Price Action

价格行为

: BMY stock is up 0.90% at $45.38 at the last check on Tuesday.

:BMY股票在周二最后一次检查时上涨了0.90%,达到45.38美元。

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Image: Shutterstock

图片:Shutterstock

BMY

百时美施贵宝公司

Bristol-Myers Squibb Co

百时美施贵宝公司

$45.08

45.08美元

0.22

0.22

%

%

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