A double-barreled cancer immunotherapy extended the lives of people with lung cancer in a closely watched trial that’s viewed as important for gauging the potential impact of the drug, known as ivonescimab, as well as others like it.

在一项备受关注的临床试验中，一种双靶点癌症免疫疗法延长了肺癌患者的生存期；该试验被视为评估名为依沃西单抗（ivonescimab）的药物及其同类药物潜在影响的重要参考。

Presented at the American Society of Clinical Oncology meeting Sunday, the findings come from a study testing ivonescimab in patients newly diagnosed with advanced, non-small cell lung cancer. Though run only in China, the study is a proxy for a global trial that could be worth tens of billions of dollars to the drug’s developers, Akeso and Summit Therapeutics.

周日在美国临床肿瘤学会（ASCO）年会上公布的研究结果，来自一项针对初诊晚期非小细胞肺癌患者使用依沃西单抗的试验。尽管该研究仅在中国开展，但它可作为一项全球临床试验的参照，有望为药物开发商康方生物（Akeso）和 Summit Therapeutics 带来数百亿美元的价值。

Like that global study, the China trial is testing an ivonescimab-chemotherapy combination against the kind of immunotherapy-chemo regimen that’s standard care for many new patients. .

与该全球研究类似，这项中国试验正在测试依沃西单抗联合化疗方案，并以目前许多初治患者的标准治疗方案（即免疫联合化疗）作为对照。

Last year, Akeso and Summit revealed that the ivonescimab regimen

去年，康方生物与Summit公司披露，依沃西单抗的治疗方案

reduced the risk of disease progression by 40%

将疾病进展的风险降低了40%

when compared to chemo and an immunotherapy called Tevimbra. But they hadn’t yet disclosed whether the drug regimen extended lives, the gold standard for a cancer medicine.

与化疗及名为Tevimbra的免疫疗法相比。但他们尚未披露该药物方案是否能延长患者生存期，而延长生存期正是抗癌药物的金标准。

Success in that objective carries implications not only for Akeso and Summit, but many others developing medicines like ivonescimab, which are known as “

该目标的成功不仅对康方生物和Summit公司意义重大，也将对许多其他正在研发依沃西单抗等药物的企业产生深远影响，这类药物被称为“

PD-1/VEGF inhibitors

PD-1/VEGF抑制剂

” because of the two proteins they target. These drugs have shown the

”，因为它们靶向的两种蛋白质。这些药物已显示出

potential to top widely used immunotherapies like Keytruda

有潜力超越Keytruda等广泛使用的免疫疗法

, sparking hope that they may become future cornerstones of cancer care. But modest results in some studies have

，燃起了它们有望成为未来癌症治疗基石的希望。但一些研究中有限的结果已

stirred debate about their additive benefits

引发了关于其叠加效益的争论

.

。

Heading into the ASCO presentation, multiple Wall Street analysts pegged a reduction in death risk of anywhere from 20% to 30% as indicative of a meaningful benefit. Ivonescimab hit that mark, with investigators disclosing Sunday that drug recipients lived a median of 28 months after enrollment, versus 24 months for the control group — a 34% relative risk reduction that was statistically significant. .

在ASCO大会召开之际，多位华尔街分析师认为，死亡风险降低20%至30%即表明具有临床意义的获益。依沃西单抗达到了这一标准。研究人员于周日公布的数据显示，用药患者入组后的中位生存期为28个月，而对照组为24个月，相对死亡风险降低了34%，且具有统计学意义。

Both drug combinations had similar side effects, such as lower counts of red and white blood cells, though the rates of those events were slightly higher among ivonescimab recipients.

两种药物组合的副作用相似，例如红细胞和白细胞计数降低，但依沃西单抗用药患者中这些事件的发生率略高。

“The demonstration of both improved progression-free survival by a substantial margin, as well as a significant overall survival [benefit], is a real step forward because it comes at the cost of very little additional toxicity,” said John Heymach, chair of thoracic and head and neck cancer care at MD Anderson Cancer Center, in an interview. .

“无进展生存期得到大幅改善，且总生存期也取得显著获益，这确实是一项重要进展，因为其几乎不增加额外的毒性，”MD安德森癌症中心胸部及头颈部肿瘤治疗科主任约翰·海马克在接受采访时表示。

Heymach, who isn’t involved in the Harmoni-6 trial but is an investigator in another ivonescimab study, noted that the medicine’s safety profile could set it apart from

未参与Harmoni-6临床试验但担任另一项依沃西单抗研究研究者的赫马奇指出，该药物的安全性特征可能使其区别于……

certain antibody-drug conjugates

某些抗体药物偶联物

that are also being tested in lung cancer. Those drugs tend to have higher side effect rates, which could limit their use among some people, he said.

这些药物也正在接受肺癌方面的测试。他表示，这类药物的副作用发生率往往较高，可能会限制其在部分人群中的使用。

The four-month absolute difference in survival observed in the study appears to have fallen short of investor expectations. Analysts at the investment bank Cantor Fitzgerald, for instance, had predicted that a six-month benefit would be viewed as clinically meaningful.

该研究中观察到的四个月生存期绝对差异似乎未能达到投资者预期。例如，投行Cantor Fitzgerald的分析师曾预测，六个月的生存获益才会被视为具有临床意义。

Still, ahead of the meeting there were warning signs ivonescimab might not hit that mark. Analysts at a different firm, Leerink Partners, noted in how the survival numbers in the study might be skewed by inconsistent access to quality care in China.

尽管如此，在会议召开前已有预警迹象表明，依沃西单抗可能无法达到该目标。另一家机构Leerink Partners的分析师指出，研究中的生存数据可能会因中国各地优质医疗资源获取不均而出现偏差。

Whether that impacted the findings is unclear. But one oncologist not involved in the study argued that the magnitude of the effects Akeso and Summit found were notable nonetheless.

这是否对研究结果产生了影响尚不明确。但一位未参与该研究的肿瘤学家认为，尽管如此，Akeso与Summit所发现的效果幅度依然十分显著。

“A few months may not seem like a lot of time for patients who already have very limited options,” but it does add to what becomes a “cumulative benefit” over time, said Lee Hong, a thoracic oncologist with City of Hope. Extending survival with an initial medication “just opens up many doors for for these patients, even [when] thinking about subsequent lines of therapy,” Hong said..

“对于治疗选择已经非常有限的患者而言，几个月似乎算不上很长的时间，但随着时间的推移，这确实能带来‘累积获益’。”希望之城（City of Hope）的胸部肿瘤学家李洪表示。他指出，通过初始药物延长生存期“为这些患者打开了许多大门，即便是在考虑后线治疗方案时也是如此。”

Ivonescimab is

依沃西单抗是

approved for use in China

已获准在中国使用

and currently under review in the U.S. as a potential treatment for certain EGFR-mutated lung cancers, with a decision expected in November. But its biggest opportunity lay ahead, if that all-important global study testing ivonescimab and chemo against chemo and Merck & Co.’s Keytruda — the primary treatment for many lung tumors — yields positive results..

目前正于美国接受审评，有望作为特定EGFR突变型肺癌的潜在治疗药物，预计将于11月做出审批决定。但其最大的机遇还在后头：若那项至关重要的全球临床试验取得积极结果——该试验旨在对比“依沃西单抗联合化疗”与“化疗联合默沙东的Keytruda”的疗效，而Keytruda正是目前许多肺癌的主要治疗药物——那么其前景将更加广阔。

Unlike the China trial, the global study, HARMONi-3, includes people with “non-squamous” disease. That difference could boost ivonescimab’s chances, as “squamous” disease tends to be more difficult to treat.

与中国试验不同，全球研究HARMONi-3纳入了“非鳞状”疾病患者。这一差异可能会提升依沃西单抗的成功几率，因为“鳞状”疾病通常更难治疗。

A final analysis from HARMONi-3 is expected later this year.

HARMONi-3 的最终分析结果预计将于今年晚些时候公布。