默沙东与Moderna个性化mRNA黑色素瘤疫苗将复发与死亡风险降低42%MSD and Moderna mRNA Vaccine Cuts Melanoma Death or Recurrence Risk by 42%

在本次涉及1137名成年受试者的临床试验中，所有参与者均接受了常规免疫药物Keytruda治疗，该药物主要通过协助人体免疫系统发现并攻击癌细胞来发挥作用。研究人员将受试者划分为不同治疗组别，其中大约三分之二的患者在接受Keytruda的同时注射了名为Intismeran的在研实验性mRNA疫苗，而剩余约三分之一的受试者则接受了安慰剂对照治疗。

In the clinical trial involving 1,137 adult participants, every patient was administered the established immunotherapy drug Keytruda, which works by assisting the human immune system in identifying and attacking malignant cells. Investigators divided the cohort into comparative treatment arms: approximately two-thirds of the enrolled patients received the experimental mRNA candidate Intismeran alongside Keytruda, while the remaining one-third received a placebo dummy injection paired with the standard immunotherapy.

临床跟踪数据显示，在开始治疗两年后，联合接受该疫苗与免疫治疗的患者，其黑色素瘤复发或向体内其他器官扩散的几率明显低于仅接受免疫药物的对照组。该疗法最终取得了患者死亡或皮肤癌复发风险降低42%、转移风险降低38%的统计成果。参与该研究的研究人员指出，这一系列数据让个性化医疗的实际应用向前推进了一步。

Follow-up evaluations established that two years after initiating therapy, participants given the investigational vaccine experienced a substantially lower likelihood of melanoma returning or spreading across the body compared with those receiving Keytruda alone. By delivering a 42 percent decline in the relative risk of recurrence or death and a 38 percent decrease in cancer spread, the combination met key therapeutic benchmarks that researchers involved in the study described as moving personalized medicine a tangible step closer to reality.

Intismeran采用与部分新冠疫苗相同的mRNA技术平台，专门面向已经接受手术切除肿瘤的癌症患者。该疗法通过采集并分析患者个体肿瘤的具体信息，量身定制核糖核酸编码，以此训练人体自身免疫系统精准识别潜在复发的恶性细胞，并在其重新生长时实施针对性清除。在英国剑桥阿登布鲁克医院协助开展部分临床研究的肿瘤医学顾问皮帕·科里（Pippa Corrie）教授指出，个性化定制是医疗技术升级的重要方向，该试验为验证该技术的实际价值提供了首个概念验证依据。

Intismeran relies on the same messenger RNA platform used in several Covid-19 shots, specifically targeting cancer patients whose tumours have already been removed surgically. The treatment analyzes molecular information extracted directly from an individual patient's own malignancy to custom-build mRNA strands, training immune defenses to spot returning malignant cells and mount a targeted attack. Professor Pippa Corrie, a consultant medical oncologist who helped coordinate patient trials at Addenbrooke's Hospital in Cambridge, described personalization as an exciting technological step forward and noted that the trial serves as the first proof of principle demonstrating its value.

75岁来自东米德兰兹郡科比的托尼·查普曼（Tony Chapman）是入组该试验的患者之一。他于2019年确诊患有黑色素瘤并接受了胸部肿瘤切除手术，但随后手臂下方出现肿块，被医生告知癌细胞已转移至淋巴结并进行了二次手术。查普曼随后志愿参与了这项临床研究，与其他受试者一样，他至今仍不清楚自己接受的是在研疫苗还是安慰剂对照注射。在确诊癌细胞扩散三年后，他目前每六个月接受一次复查，体内至今保持无癌状态。

Among the participants was 75-year-old Tony Chapman from Corby in the East Midlands, who was diagnosed with melanoma in 2019 and had a primary tumor removed from his chest. When a subsequent lump under his arm revealed the cancer had spread to his lymph nodes, Chapman underwent a second operation before volunteering for the clinical trial. Like other participants in the blinded study, he does not know whether he received the experimental vaccine or a dummy injection alongside immunotherapy. Three years after doctors discovered the lymph node spread, Chapman continues to attend check-ups every six months and remains cancer-free.

在黑色素瘤试验取得积极数据后，制药企业默沙东与Moderna正在推进将这一相同的个体化治疗方案应用到其他癌症类型中。两家药企披露，目前该技术已同步在肾癌、膀胱癌以及肺癌患者中开展临床测试，旨在评估针对切除术后复发风险高的患者定制mRNA疫苗能否同样提升整体免疫防御水平。

Following the results in melanoma, pharmaceutical manufacturers MSD and Moderna are actively advancing the identical personalized approach into clinical evaluations for other cancers. Both companies confirmed that ongoing trials are already testing the therapeutic model in cohorts diagnosed with kidney cancer, bladder cancer, and lung cancer, evaluating whether custom-built mRNA injections can similarly bolster host immune defenses in patients who face elevated chances of recurrence after surgical resection.

除了默沙东与Moderna针对上述实体瘤的试验外，科学界也在更广泛地探索利用疫苗疗法对抗多种高致命性恶性肿瘤。相关研究正在深入胶质母细胞瘤和胰腺癌等治疗难度极大的领域，力图验证针对不同肿瘤特征设计的癌症疫苗在激发针对性免疫反应方面的潜在应用价值。

Beyond the specific tumour types under investigation by MSD and Moderna, researchers across the scientific community are studying vaccine concepts across a wider spectrum of malignancies. Investigations now extend into particularly difficult clinical targets such as glioblastoma and pancreatic cancer, exploring whether vaccine strategies tailored to diverse malignant signatures can effectively stimulate immune responses against stubborn solid tumours.

默沙东与Moderna确认，他们目前正在与药品监管机构保持沟通，透露最早可能在明年正式提交上市许可申请。资本市场上，自两家药企在夏季首次暗示该疫苗研发取得进展以来，其股票价格曾经历明显上涨。然而在最新数据公布后的周四，部分投资者选择抛售股票，主要是金融分析人士指出，本次大规模试验所展现的效果略逊于早期规模更小的初步试验数据。

MSD and Moderna confirmed that they are actively engaging with medicine regulators, indicating that they could formally file for marketing approval as early as next year. In financial markets, shares in both companies had climbed sharply since executives first hinted at the candidate's clinical success earlier in the summer. However, investors offloaded stock on Thursday following commentary from financial analysts, who noted that the latest findings from the large-scale trial were not quite as robust as data generated by an earlier, significantly smaller study.

独立癌症专家虽然肯定了试验数据的价值，但强调仍需要进行更长期的临床观察，以明确该疗法是否确实能帮助大多数患者延长平均生存期。此外，由于每位患者都必须接受单独的肿瘤基因测序并度身定制疫苗，高昂的生产与治疗成本将成为英国国家医疗服务体系等公共卫生系统能否实现广泛普及的重要决定因素。

Independent cancer experts cautioned that while the latest trial outcomes are notable, longer-term research remains necessary to conclusively prove whether the regimen helps patients live longer on average. Significant manufacturing and economic obstacles also remain before health systems can adopt the drug widely. Because every patient requires individual tumour genetic sequencing to formulate a bespoke therapy, the high cost of personalized production poses a substantial challenge for broad implementation in public healthcare programs, such as the National Health Service.