MSD and partner Moderna have started a late-stage trial of their personalised cancer vaccine V940 as a combination with MSD’s PD-1 inhibitor Keytruda for patients with non-small cell lung cancer (NSCLC).

MSD和合作伙伴Moderna已经开始了他们的个性化癌症疫苗V940的后期试验，该疫苗与MSD的PD-1抑制剂Keytruda联合用于非小细胞肺癌（NSCLC）患者。

MSD – known as Merck & Co in North America – said this morning that the phase 3 INTerpath-002 study will look at the combination as adjuvant therapy for patients with stage II, IIIA or IIB NSCLC that has been removed with surgery, to see if it is more effective than Keytruda plus placebo at preventing the cancer from returning..

MSD（北美称为默克公司）今天上午表示，INTerpath-002第三阶段研究将研究这种联合疗法作为II期，IIIA期或IIB期NSCLC患者的辅助治疗，这些患者已经通过手术切除，看看它在预防癌症复发方面是否比Keytruda加安慰剂更有效。。

Patients in the study will receive a 1 mg dose of V940 via intramuscular (IM) injection or a matched placebo once every three weeks for up to nine doses along with an infusion of Keytruda once every six weeks for up to nine doses.

该研究中的患者将每三周通过肌内（IM）注射或匹配的安慰剂接受1 mg剂量的V940，最多九剂，同时每六周输注一次Keytruda，最多九剂。

The primary endpoint of the trial is disease-free survival (DFS) with an overall follow-up period of up to 78 months, so it will be some time before efficacy data is available.

该试验的主要终点是无病生存期（DFS），总体随访期长达78个月，因此需要一段时间才能获得疗效数据。

Secondary endpoints include overall survival (OS), distant metastasis-free survival (DMFS), lung cancer-specific survival (LCSS) and quality of life, with patients expected to be followed up for around 12 years overall.

次要终点包括总生存期（OS），无远处转移生存期（DMFS），肺癌特异性生存期（LCSS）和生活质量，预计患者总体随访约12年。

Recruitment for INTerpath-002 is already underway around the world and the first patients have been enrolled in Australia, said MSD

MSD说，INTerpath-002的招募工作已经在世界各地进行，首批患者已经在澳大利亚登记

The decision is another endorsement of the potential of V940 – also known as mRNA-4157 – which is a personalised vaccine targeting 34 cancer neoantigens derived from patients' own tumours.

这一决定再次肯定了V940（也称为mRNA-4157）的潜力，V940是一种针对34种源自患者自身肿瘤的癌症新抗原的个性化疫苗。

In July, MSD and Moderna decided to take the combination of the vaccine and Keytruda into a phase 3 trial called INTerpath-001 (formerly V940-001) for skin cancer melanoma, once again as an adjuvant therapy, in patients with stage IIB to IV disease.

7月，MSD和Moderna决定将疫苗和Keytruda联合用于皮肤癌黑色素瘤的3期临床试验，称为INTerpath-001（以前称为V940-001），再次作为IIB至IV期患者的辅助治疗。

That decision was based on the results of the phase 2b KEYNOTE-942 trial, which showed that the combination reduced the risk of distant metastasis or death by 65% compared to Keytruda alone in high-risk, resected melanoma patients.

这一决定是基于2b期KEYNOTE-942试验的结果，该试验表明，与高危切除黑色素瘤患者单独使用Keytruda相比，联合用药可将远处转移或死亡的风险降低65%。

mRNA-4157 is designed to prime the immune system to attack the tumour cells, while Keytruda blocks an immunological ‘brake’ that protects the cancer.

mRNA-4157被设计用于引发免疫系统攻击肿瘤细胞，而Keytruda阻断了保护癌症的免疫“刹车”。

“Addressing lung cancer reflects the constant struggle between medical innovation and biological complexity. Each patient’s cancer presents a labyrinth of genetic mutations, driving a novel approach of individualised medicines manufactured based on the distinct molecular tumour profile for each patient,” said Kyle Holen, Moderna’s head of development, therapeutics and oncology.

Moderna开发、治疗和肿瘤学负责人凯尔·霍伦（KyleHolen）表示：“解决肺癌问题反映了医学创新与生物学复杂性之间的不断斗争。每位患者的癌症都呈现出错综复杂的基因突变，推动了一种基于每位患者独特的分子肿瘤特征制造个性化药物的新方法。”。

.

.

“We believe an individualised neoantigen therapy can be this catalyst for innovation and drive us forward towards the next frontier of cancer care,” he added.

他补充道：“我们相信个性化的新抗原疗法可以成为创新的催化剂，并推动我们朝着癌症治疗的下一个前沿前进。”。

MSD took up an option on the personalised RNA-based cancer vaccine last year, with an upfront payment of $250 million, as part of a collaboration that was first signed in 2016. The partnership was expanded in 2018 before the mRNA vaccine technology showed its worth in the COVID-19 pandemic.

作为2016年首次签署的合作协议的一部分，MSD去年选择了基于RNA的个性化癌症疫苗，预付款为2.5亿美元。在mRNA疫苗技术在新型冠状病毒肺炎大流行中显示其价值之前，该合作关系于2018年扩大。

Moderna’s arch-rival in the mRNA vaccine category, BioNTech, is also developing a personalised cancer vaccine called BNT111, based on four melanoma-associated antigens, in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in a phase 2 trial, with results due in 2025.

Moderna在mRNA疫苗类别中的主要竞争对手BioNTech也在开发一种名为BNT111的个性化癌症疫苗，该疫苗基于四种黑色素瘤相关抗原，并与Regeneron的PD-1抑制剂Libtayo（cemiplimab）联合进行2期试验，结果将于2025年公布。

One issue facing personalised cancer vaccines that will have to be addressed later is how their individualised production can be scaled up so that they can become viable, affordable options for health systems, although that has been achieved with other therapies such as CAR-Ts.

个性化癌症疫苗面临的一个问题将在以后得到解决，即如何扩大其个性化生产规模，使其成为卫生系统可行且负担得起的选择，尽管这已经通过CAR-Ts等其他疗法实现了。