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安进:药物联合疗法使侵袭性肺癌患者死亡风险降低58%Amgen says drug combo cuts risk of death by 58% in patients with aggressive lung cancer

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一项研究发现,安进公司的一款药物若与阿斯利康公司的免疫疗法药物联用,可使患有一种以侵袭性著称的肺癌的患者显著延长生存时间。

A drug from Amgen could give patients with a notoriously aggressive form of lung cancer significantly more time to live when added to an immunotherapy from AstraZeneca, a study found.

周六发布的一项晚期临床试验的完整结果显示,将安进的免疫疗法药物Imdelltra添加到阿斯利康的Imfinzi药物中,使广泛期小细胞肺癌患者的死亡风险降低了58%,这是一种生长迅速且已扩散到起始肺部以外的疾病。

Full results from a late-stage trial released Saturday show that adding Amgen's immunotherapy Imdelltra to AstraZeneca's Imfinzi drug slashed the risk of death by 58% in patients with extensive-stage small cell lung cancer, a fast-growing disease that has spread beyond the lung where it began.

该试验发现,这种药物组合将患者的中位总生存期延长至21.1个月,而单用阿斯利康药物的患者为12.7个月。

The drug combination extended their median overall survival to 21.1 months compared with 12.7 months with AstraZeneca's drug alone, the trial found.

这意味着,接受联合疗法组别的一半患者至少存活了约21个月。该试验将这种联合疗法作为维持治疗进行测试,对象是接受过Imfinzi联合化疗的初始治疗、且癌症未进展的患者。

That means half of patients in the group that took the combination regimen were alive for at least roughly 21 months. The trial tested the combo as a maintenance therapy in patients who received initial treatment with Imfinzi and chemotherapy, and whose cancer had not progressed.

安进首席医疗官保罗·伯顿博士在接受采访时表示:“我认为在医学领域,有时你会看到一组数据如此深远,以至于它将改变患者的标准治疗方案,我认为,诚实地说,我们正处于这一时刻。”

"I think there are moments in medicine when you see a piece of data that is so profound that it's going to transform the standard of care for patients, and I think, honestly, we're at that moment," said Dr. Paul Burton, Amgen's chief medical officer, in an interview.

他表示,这种组合“有可能应对我们目前面临的最侵袭性癌症之一,并几乎将其转化为一种慢性病”,并补充说“这些数据表明这是一种可能性。” 结果还暗示了Imdelltra更大的商业机会,该药物在第二季度实现了2.88亿美元的销售额,同比增长115%。该药物在2025年已实现6.27亿美元的全球销售额,并似乎正朝着成为一款大爆款药物(即达到10亿美元销售额门槛)的方向发展。

The combination "has the potential to take on one of the most aggressive cancers that we deal with today, and almost convert it into a chronic disease," he said, adding that "these data say that's a possibility." The results also suggest a greater commercial opportunity for Imdelltra, which posted $288 million in sales during the second quarter, up 115% year over year. The drug already generated $627 million in global sales in 2025 and appears to be on its way to becoming a blockbuster medicine, or hitting the $1 billion sales threshold.

主要试验研究者、达纳-法伯癌症研究所Lowe胸部肿瘤中心副主任Jacob Sands医生表示,小细胞肺癌仍然难以治疗,因为即使化疗最初对大多数患者效果良好,疾病通常也会在几个月内复发或进展。

Small cell lung cancer remains difficult to treat because, even if chemotherapy initially works well for most patients, the disease often returns or progresses within months, said lead trial investigator Dr. Jacob Sands, who is the associate chief of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute.

他表示,免疫疗法帮助一小部分患者实现了数年的疾病控制,但大多数患者并未获得类似的持久获益,这凸显了对更好疗法的需求。美国每年约有3.1万例新发小细胞肺癌病例,据估计其中60%至70%的患者确诊时已处于广泛期。

He said immunotherapy has helped a small subset of patients achieve years of disease control, but most have not experienced similarly durable benefits, highlighting the need for better treatments. There are roughly 31,000 new small cell lung cancer cases in the U.S. each year, and an estimated 60% to 70% of those people are diagnosed with extensive-stage disease.

Sands表示,试验获益在各患者亚组中均有体现,包括癌细胞扩散至脑部或肝部的患者。扩散至这些器官的疾病与较差的治疗预后相关。

Sands said the benefits in the trial were seen across subgroups of patients, including those whose cancer spread to the brain or liver. Disease that has spread to those organs is associated with poorer treatment outcomes.

他补充说,随着对患者更长期的随访数据积累,21个月这一数字“可能会进一步演变,并有望大幅改善”,这与安进在该免疫疗法组合的1期试验中观察到的情况类似。在那项规模较小的早期试验中,长期随访显示获益持续了数年。

He added that with longer-term follow-up data on the patients, the 21-month figure "may evolve further and hopefully will substantially improve," similar to what Amgen saw in a Phase 1 trial on the immunotherapy combination. In that early-stage trial on a smaller number of patients, a long-term follow-up showed the benefit was sustained for years.

安进表示,研究结果还提示,在患者治疗早期使用Imdelltra(替沃单抗)可能会显著改变疾病轨迹。Imdelltra目前获批用于铂类化疗期间或之后疾病进展的小细胞肺癌患者。

Amgen said the findings also suggest that using Imdelltra earlier in a patient's treatment could meaningfully alter the trajectory of the disease. Imdelltra is currently approved for patients whose small cell lung cancer has progressed while they are on, or after, platinum-based chemotherapy.

研究人员专门测试了在Imfinzi(度伐利尤单抗)基础上添加Imdelltra,是否能比单用Imfinzi让患者生存更久;Imfinzi已获批作为该类肺癌的一线治疗。安进称,开始联合用药的患者中近80%在一年后存活,而单用Imfinzi组为53%。

Researchers specifically tested whether adding Imdelltra could help patients live longer than continuing Imfinzi alone, which is already approved as a first treatment for this type of lung cancer. Amgen said nearly 80% of patients who started taking both drugs were alive at one year compared with 53% receiving Imfinzi alone.

Sands 表示,Imdelltra 在控制疾病方面的“巨大影响”,以及最终对患者生存期的影响,凸显了将其纳入一线维持治疗的重要性。一线维持治疗是指在初始强化治疗(如化疗或手术)后给予的持续性治疗。

Imdelltra's "big impact" on controlling the disease and ultimately how long people live highlights the importance of including it in first-line maintenance treatment, Sands said. That refers to ongoing therapy given after an initial heavy treatment, such as chemotherapy or surgery.

Burton 补充说,这使得 Amgen 的药物有望成为小细胞肺癌“不可或缺的基石疗法”,无论它搭配哪种其他免疫疗法。

Burton added that it positions Amgen's drug to be an "indispensable backbone therapy" for small cell lung cancer, regardless of the other immunotherapy that can be paired with it.

Imdelltra 可结合癌细胞上的 DLL3 蛋白和 T 细胞上的 CD3 蛋白,T 细胞是一种能够杀灭癌细胞的免疫细胞。通过同时结合这两种蛋白,Imdelltra 使 T 细胞与肿瘤细胞紧密接触,帮助免疫系统消灭癌症。

Imdelltra binds to DLL3, a protein on cancer cells, and CD3, a protein on T cells, which are a type of immune cell that can kill cancer. By binding to both, Imdelltra brings T cells into close contact with tumor cells, helping the immune system destroy the cancer.

阿斯利康生产的 Imfinzi 是一种免疫疗法,它阻断一种名为 PD-L1 的蛋白,癌细胞利用这种蛋白逃避免疫系统。这两种药物以互补方式协同作用:Imfinzi 有助于解除免疫反应的“刹车”,而 Imdelltra 将 T 细胞直接带到癌细胞旁并帮助激活它们攻击肿瘤。

Imfinzi, made by AstraZeneca, is an immunotherapy that blocks a protein called PD-L1, which cancer cells use to evade the immune system. The drugs work together in complementary ways: Imfinzi helps remove the brakes on the immune response, while Imdelltra brings T cells directly to cancer cells and helps activate them to attack the tumor.

这项研究在一个名为欧洲肿瘤内科学会大会的大型癌症会议上发布,并未测试该联合疗法是否优于其他一线治疗方案。

The study, which was presented at a major cancer meeting called the European Society for Medical Oncology Congress, did not test whether the combination was better than other first-line treatment approaches.

尽管如此,研究结果表明,Amgen 的药物可能成为小细胞肺癌患者在治疗早期可获得的另一种选择。来自丹佛的 44 岁两个孩子的母亲 Kate Brenan 认为,这本身就是一种胜利。

Still, the findings suggest Amgen's drug could be another option offered to small cell lung cancer patients earlier in their treatment. Kate Brenan, a 44-year-old mother of two from Denver, sees that as a win on its own.

她于 2024 年 1 月初被诊断为广泛期小细胞肺癌。Brenan 接受了六个周期的常规联合化疗,随后进行了胸部放疗,癌症扩散后又接受了全脑放疗。

She was diagnosed with extensive-stage small cell lung cancer in early January 2024. Brenan underwent six rounds of a common combination chemotherapy, followed by chest radiation and later whole-brain radiation after the cancer spread.

2024 年 9 月,她开始使用 Imdelltra,此后一直无病迹象。

In September 2024, she started Imdelltra and has had no evidence of disease ever since.

“我认为,在小细胞癌治疗选择领域,事态变化之快令人瞩目,”布雷南对CNBC表示,并补充说,Imdelltra(伊姆德特拉)有可能成为更早期的治疗选择,“这对患者未来而言只会是好事,我对此感到非常兴奋。”

"I think that it's remarkable how quickly things are changing in the world of small cancer treatment options," Brenan told CNBC, adding that Imdelltra potentially becoming an earlier treatment option "can only be a good thing for the patients moving forward, and I'm really excited about that."

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