MSD and Moderna’s individualised cancer vaccine mRNA-4157 has shown impressive efficacy in a phase 2b trial in skin cancer melanoma, leaving the partners speculating about a possible regulatory filing.

MSD和Moderna的个体化癌症疫苗mRNA-4157在皮肤癌黑色素瘤的2b期试验中显示出令人印象深刻的功效，这让合作伙伴们猜测可能的监管申请。

New results from the KEYNOTE-942 study have revealed that combining mRNA-4157 (also known as V940) with MSD’s PD-1 inhibitor Keytruda (pembrolizumab) resulted in a 49% reduction in the risk of recurrence or death after three years compared to Keytruda alone in patients with high-risk stage III-IV melanoma following complete resection..

KEYNOTE-942研究的新结果显示，将mRNA-4157（也称为V940）与MSD的PD-1抑制剂Keytruda（pembrolizumab）联合使用，与完全切除后高危III-IV期黑色素瘤患者单独使用Keytruda相比，三年后复发或死亡风险降低了49%。。

The result shows that the benefits of the personalised vaccine are durable, and according to analysts could be strong enough for MSD and Moderna to seek accelerated approval for the therapy from the FDA. Data reported at this year’s AACR cancer congress showed that the regimen achieved a 44% reduction in recurrence or death at 18 months.

结果表明，个性化疫苗的益处是持久的，据分析人士称，MSD和Moderna可能足够强大，可以寻求FDA加速批准该疗法。今年AACR癌症大会报告的数据显示，该方案在18个月时复发或死亡减少了44%。

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Two-year distant metastasis-free survival rates were also presented at AACR, showing a 65% reduction, and the new update indicates that has largely been maintained with a 62% difference at three years.

AACR也显示了两年的无远处转移生存率，降低了65%，新的更新表明，三年的差异很大程度上保持了62%。

Shares in Moderna rose sharply after the announcement, although the stock has seen a steady decline in recent months thanks to a collapse in demand for Moderna’s COVID-19 vaccines.

声明发布后，Moderna的股价大幅上涨，但由于对Moderna新型冠状病毒疫苗的需求锐减，该股近几个月稳步下跌。

Moderna has already started a phase 3 trial of the combination in melanoma, codenamed INTerpath-001, which will enrol around 1,089 patients with high-risk, stage IIB-IV melanoma who have had surgical resection to remove the tumour. The primary endpoint is recurrence-free survival, with overall survival and metastasis-free survival as secondary endpoints..

Moderna已经开始了一项联合治疗黑色素瘤的3期临床试验，代号为INTerpath-001，该试验将招募约1089名高风险IIB-IV期黑色素瘤患者，这些患者已经进行了手术切除以切除肿瘤。主要终点是无复发生存期，总生存期和无转移生存期作为次要终点。。

Final results are estimated sometime from 2029 onwards, so the big question for MSD and Moderna now is whether they wait for the initial readouts from that trial or go with a regulatory filing earlier, banking on the phase 3 as a confirmatory study.

最终结果估计在2029年以后的某个时候，因此MSD和Moderna现在面临的一个大问题是，他们是等待该试验的初步读数，还是更早地进行监管备案，将第三阶段作为验证性研究。

The latter looks likely, given remarks by Moderna chief executive Stéphane Bancel that the vaccine could get approval as early as 2025. That timeframe suggests the company may be waiting for additional data from KEYNOTE-942, which is still only halfway through its follow-up period, as well as the completion of a manufacturing facility that is being constructed in Massachusetts.

鉴于Moderna首席执行官Stéphane Bancel表示该疫苗最早可能在2025年获得批准，后者似乎很有可能。该时间表表明，该公司可能正在等待KEYNOTE-942的额外数据，该数据仍处于后续阶段的一半，以及正在马萨诸塞州建造的制造工厂的完工。

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In the meantime, MSD (known as Merck & Co in North America) and Moderna have also started a second phase 3 study (INTerpath-002) of the combination as adjuvant therapy for non-small cell lung cancer (NSCLC), and have said they “plan to rapidly expand to additional tumour types.”

与此同时，MSD（北美称为默克公司）和Moderna也开始了第二阶段3研究（INTerpath-002），将其作为非小细胞肺癌（NSCLC）的辅助治疗，并表示“计划迅速扩大到其他肿瘤类型”

mRNA-4157 is a personalised vaccine consisting of 34 mRNAs, each targeting ‘neoantigens’ identified by gene sequencing that are thought to be driving a patient’s cancer. The vaccine is designed to prime the immune system to attack the tumour cells, while Keytruda blocks an immunological ‘brake’ that protects the cancer..

mRNA-4157是一种个性化疫苗，由34个mRNA组成，每个mRNA靶向通过基因测序鉴定的“新抗原”，这些基因被认为是导致患者癌症的原因。该疫苗旨在引发免疫系统攻击肿瘤细胞，而Keytruda则阻断了保护癌症的免疫“刹车”。。

MSD took up an option on the personalised RNA-based cancer vaccine with an upfront payment of $250 million as part of a collaboration that was first signed in 2016 and expanded in 2018. It has secured FDA breakthrough therapy and EMA PRIME designations which could speed its path through to approval..

MSD选择了个性化的基于RNA的癌症疫苗，预付款2.5亿美元，作为2016年首次签署并于2018年扩大的合作的一部分。它已经获得了FDA突破性治疗和EMA主要名称，这可能会加快其获得批准的速度。。