New mRNA Vaccine Reduces Risk of Melanoma Recurrence by Over 40 Percent

An experimental vaccine offers new hope to patients with melanoma, one of the most aggressive forms of skin cancer. The pharmaceutical companies Merck and Moderna released the results of a Phase 3 clinical trial that evaluated the efficacy of a personalized mRNA-based vaccine that, when combined with immunotherapy, reduced the risk of disease recurrence or death by 42 percent compared to treatment with the immunotherapy drug alone.

一种实验性疫苗为黑色素瘤患者带来了新的希望，这是最具侵袭性的皮肤癌之一。制药公司默克（Merck）和莫德纳（Moderna）公布了一项三期临床试验的结果，该试验评估了一种个性化mRNA疫苗的疗效。结果显示，与单独使用免疫疗法药物相比，该疫苗与免疫疗法联合使用可将疾病复发或死亡的风险降低42%。

Georgina Long, medical director of the Australian Melanoma Institute and the study’s principal investigator, said in a statement that these results are “transformative” and “have the potential to make a foundational shift in how we treat patients with earlier-stage melanoma.”

澳大利亚黑色素瘤研究所医学主任兼该研究的首席研究员乔治娜·朗（Georgina Long）在一份声明中表示，这些结果具有“变革性”，并“有可能从根本上改变我们治疗早期黑色素瘤患者的方式”。

The trial, known as INTerpath-001, included 1,137 people with high-risk melanoma who had undergone surgery to completely remove their tumors. The participants were divided into two groups. Those in the first group received only Pembrolizumab, a drug that helps the immune system detect and fight cancer cells, while those in the second group were treated with the same drug in combination with the mRNA vaccine, called Intismeran Autogene.

这项被称为INTerpath-001的试验纳入了1137名已通过手术完全切除肿瘤的高危黑色素瘤患者。参与者被分为两组。第一组仅接受帕博利珠单抗（Pembrolizumab）治疗，这是一种帮助免疫系统检测并对抗癌细胞的药物；而第二组则接受了同种药物与名为Intismeran Autogene的mRNA疫苗的联合治疗。

After monitoring the participants for an average of 24.6 months, the researchers determined that addition of the vaccine reduced the risk of cancer recurrence or death by 42 percent compared to Pembrolizumab alone.

在对参与者进行了平均24.6个月的监测后，研究人员确定，与单独使用帕博利珠单抗相比，加入该疫苗可将癌症复发或死亡的风险降低42%。

The results also showed that the experimental treatment reduced the risk of the disease spreading to other parts of the body by 38 percent. At the end of the follow-up period, 82.2 percent of patients who received both treatments remained recurrence-free, compared with 70 percent of those who received Pembrolizumab alone.

结果还显示，这种实验性疗法将疾病扩散到身体其他部位的风险降低了38%。在随访期结束时，接受两种治疗的患者中有82.2%保持无复发状态，而仅接受帕博利珠单抗治疗的患者中这一比例为70%。

“The results of the INTerpath-001 study represent a major breakthrough in the treatment of melanoma and, in particular, in the development of personalized medicine,” Eva Muñoz Couselo—who leads a melanoma research group at the Vall d’Hebron Institute of Oncology, in Barcelona and who was not involved in the study—told SMC Spain. “For the first time, a Phase III trial has demonstrated that an individualized therapeutic vaccine, designed on the basis of the molecular characteristics of each patient’s tumor, can significantly improve the outcomes of conventional immunotherapy.”

“INTerpath-001研究的结果代表了黑色素瘤治疗，特别是精准医疗发展的一项重大突破，”巴塞罗那瓦尔德希布隆肿瘤研究所（Vall d’Hebron Institute of Oncology）黑色素瘤研究小组负责人、未参与该研究的伊娃·穆尼奥斯·库塞洛（Eva Muñoz Couselo）告诉西班牙科学媒体中心（SMC Spain）。“这是首次有三期临床试验表明，根据每位患者肿瘤的分子特征设计的个体化治疗性疫苗，可以显著改善传统免疫疗法的效果。”

The laboratories explained that the vaccine was developed from a tumor sample taken from each patient, which was used to identify specific mutations that would create distinct proteins the immune system could learn to recognize in order to attack cancer cells. The scientists selected up to three of these molecular signatures per patient.

实验室解释称，该疫苗是根据从每位患者身上提取的肿瘤样本开发的，用于识别特定的突变，这些突变会产生独特的蛋白质，免疫系统可以学习识别这些蛋白质，从而攻击癌细胞。科学家们为每位患者选择了最多三种此类分子特征。

During the trial, some participants experienced mild side effects such as fever, fatigue, and pain at the injection site. These side effects were seen in earlier trials as well, and the Phase 3 findings demonstrate similar safety when the vaccine is used in the combination with Pembrolizumab.

在试验期间，一些参与者出现了发烧、疲劳和注射部位疼痛等轻微副作用。这些副作用在早期的试验中也曾出现，而三期研究结果表明，当该疫苗与帕博利珠单抗联合使用时，安全性表现相似。

“These results reinforce our conviction that mRNA has the potential to fundamentally change how we treat cancer,” Stéphane Bancel, CEO of Moderna, said in a statement.

莫德纳首席执行官斯特凡·班塞尔（Stéphane Bancel）在一份声明中表示：“这些结果加强了我们的信念，即mRNA有潜力从根本上改变我们治疗癌症的方式。”

The pharmaceutical companies emphasized that the vaccine is not designed to prevent melanoma but rather to reduce the risk of recurrence and death following prior medical treatment. They also noted that the therapy remains under investigation to validate its efficacy and obtain approval from health authorities before widespread use.

制药公司强调，该疫苗并非旨在预防黑色素瘤，而是为了降低先前医疗治疗后的复发和死亡风险。他们还指出，该疗法目前仍在接受调查，以验证其疗效并在广泛使用前获得卫生部门的批准。

Most people diagnosed with melanoma have a high chance of survival, especially if detected early, but as one of the most common cancers, melanoma kills over 50,000 people globally each year. In theory, similar vaccines could be developed for other kinds of tumors in the future. Earlier this year, another trial demonstrated that personalized mRNA vaccines can greatly improve survival among patients with pancreatic cancer, one of the deadliest kinds of tumor.

大多数被诊断出患有黑色素瘤的人生存几率很高，尤其是在早期发现的情况下。但作为最常见的癌症之一，黑色素瘤每年在全球范围内导致超过5万人死亡。从理论上讲，未来可以为其他类型的肿瘤开发类似的疫苗。今年早些时候，另一项试验表明，个性化mRNA疫苗可以大大提高胰腺癌（最致命的肿瘤之一）患者的生存率。

“This is the major breakthrough, because conceptually it would make it possible to treat not only melanoma but also other tumors in which the immune system can be reactivated,” Marisol Soengas—a leading melanoma researcher at Spain’s National Cancer Research Center also not involved in the trial—told SMC Spain.

“这是一个重大突破，因为从概念上讲，它不仅可以治疗黑色素瘤，还可以治疗其他可以通过重新激活免疫系统来治疗的肿瘤，”西班牙国家癌症研究中心（National Cancer Research Center）的首席黑色素瘤研究员、同样未参与该试验的玛丽索尔·索恩加斯（Marisol Soengas）告诉西班牙科学媒体中心。

That doesn’t mean a cure for cancer is right around the corner. “The challenge is to ensure that this personalization can be scaled up to a large number of patients and that the cost is affordable for health care systems,” Soengas said. “It is logistically complex. It is literally a bespoke vaccine.”

但这并不意味着癌症治愈指日可待。“挑战在于确保这种个性化治疗能够推广到大量患者，并且医疗系统能够负担得起成本，”索恩加斯说。“这在后勤上很复杂。它确实是一种定制疫苗。”