Dive Brief:

概要：

A drug combination involving Bristol Myers Squibb’s experimental medicine iberdomide

涉及百时美施贵宝实验药物iberdomide的药物组合

met one of its main goals in a Phase 3 clinical trial

在三期临床试验中实现了其主要目标之一

, helping to eliminate signs of multiple myeloma in significantly more enrollees than a standard regimen, the company said Tuesday.

，公司周二表示，该疗法在显著更多的受试者中帮助消除了多发性骨髓瘤的迹象。

The data are from an interim analysis of a study that will continue so trial investigators can measure other goals like an impact on disease progression and survival. Bristol Myers will submit the results to health regulators, although executives have previously said an approval would

这些数据来自一项研究的中期分析，该研究将继续进行，以便试验调查人员可以衡量其他目标，如对疾病进展和生存的影响。百时美施贵宝公司将向卫生监管机构提交结果，尽管高管们此前曾表示，获得批准将

probably only come

可能只会出现

if iberdomide meets its other objectives.

如果iberdomide达到其他目标。

Iberdomide is one of three protein-degrading drugs Bristol Myers is positioning as successors to blockbuster blood cancer drugs like Revlimid and Pomalyst, which it acquired through its merger with Celgene. Many of the products in its large portfolio of cancer drugs have either plateaued or are in decline..

Iberdomide 是百时美施贵宝（Bristol Myers）定位为接替 Revlimid 和 Pomalyst 等重磅血液癌药物的三种蛋白质降解药物之一，这些药物是通过与新基（Celgene）合并获得的。其庞大的抗癌药物产品组合中的许多产品要么已达到平台期，要么正在下降。

Dive Insight:

深入洞察：

Called Excaliber-RRMM, the study Bristol Myers discussed Tuesday tested

名为Excaliber-RRMM的研究，百时美施贵宝周二讨论的测试

iberdomide alongside two other drugs, Darzalex and the steroid dexamethasone, and compared that regimen to a widely used treatment combination: Darzalex, dexamethasone and another medicine called Velcade. The trial enrolled people whose multiple myeloma returned after, or didn’t respond to, an initial treatment..

在这项试验中，研究人员将iberdomide与另外两种药物——Darzalex和类固醇地塞米松联合使用，并将该方案与一种广泛使用的治疗组合（Darzalex、地塞米松和另一种名为Velcade的药物）进行了比较。该试验招募了那些多发性骨髓瘤在初始治疗后复发或无反应的患者。

One of the study’s top goals was for iberdomide to be associated with an improvement in the rates of people who are “minimal residual disease negative,” or have a very low number of malignant cells in the bone marrow following treatment. Though Bristol Myers didn’t provide specifics, it said its treatment met that mark..

这项研究的首要目标之一是让伊贝多胺与“微小残留病阴性”率的提高相关，或者说在治疗后骨髓中恶性细胞数量非常少。尽管百时美施贵宝没有提供具体细节，但表示其治疗达到了这一目标。

Still, iberdomide has more to prove. A second endpoint, progression-free survival, is also considered “co-primary” under the trial’s statistical analysis plan, meaning the study wouldn’t be successful unless it helps keep patients’ myeloma in check. Its ability to extend survival, a key secondary goal, will also be closely watched. .

不过，Iberdomide 还有更多需要证明的地方。在试验的统计分析计划中，第二个终点指标无进展生存期也被视为“共同主要”终点，这意味着除非该研究能够帮助控制患者的骨髓瘤，否则研究将不会被认为是成功的。其延长生存期的能力——一个关键的次要目标——也将受到密切关注。

“We would have to look at the totality of the data, that other endpoints are moving in the right direction, because the supportive evidence would be needed from a regulatory perspective,” said Samit Hirawat, Bristol Myers’

“我们必须查看数据的总体情况，确保其他终点指标朝着正确的方向发展，因为从监管的角度来看，我们需要支持性证据，”百时美施贵宝的萨米特·希拉瓦特表示。

then-chief medical officer

时任首席医疗官

, when asked about iberdomide’s approval prospects during a July conference call.

，当在七月份的电话会议中被问及伊贝多胺的审批前景时。

Drugs like

像这样的药物

iberdomide

艾贝多米德

work by

通过工作

tagging certain proteins

标记特定蛋白质

essential for cell survival for destruction by the body’s own regular disposal mechanisms. Bristol Myers sees them as next-generation versions of Revlimid, which hit nearly $13 billion in sales at its peak in 2021, and Pomalyst, which recorded sales of $3.5 billion in 2024.

对细胞生存至关重要，可通过身体自身的常规处理机制进行破坏。百时美施贵宝将它们视为下一代的来那度胺（Revlimid），该药物在2021年的销售峰值接近130亿美元，以及2024年销售额达35亿美元的泊马度胺（Pomalyst）。

Consensus estimates have iberdomide generating

共识估计表明，iberdomide将产生

around $1.3 billion annual sales in 2035, Leerink Partners analyst David Risinger wrote in a July note to clients. “If the iberdomide data are promising, we see substantial upside” to that consensus, he wrote.

Leerink Partners的分析师大卫·莱辛格在7月给客户的一份报告中写道，到2035年，年销售额将达到约13亿美元。他写道：“如果iberdomide的数据令人鼓舞，我们认为这一共识有显著的上升空间。”