An investigational mRNA cancer vaccine developed by Moderna and Merck reached its primary efficacy endpoint, inducing a clinically meaningful improvement in recurrence-free survival.
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An investigational mRNA cancer vaccine being developed by Moderna and Merck reached its primary efficacy endpoint, inducing a clinically meaningful improvement in recurrence-free survival for patients with stage III/IV melanoma, the companies announced Tuesday.
In the Phase IIb KEYNOTE-942 trial, patients treated with mRNA-4157/V940 plus Merck’s Keytruda (pembrolizumab) saw a 44% reduction in the risk of recurrence or death, as compared to those given Keytruda alone. This effect proved to be statistically significant, with a p-value of 0.0266.
According to Moderna Chief Executive Stéphane Bancel, after proving to be pivotal in controlling COVID-19, these results “have demonstrated the potential for mRNA” technology in cancer, particularly melanoma.
KEYNOTE-942 is an ongoing randomized and open-label study with nearly 160 stage III/IV melanoma patients enrolled. After complete resection, patients were given either a combination of the mRNA cancer vaccine and Keytruda or Keytruda alone.
Aside from recurrence-free survival, the safety profile of mRNA-4157/V940 was consistent with that previously documented in a Phase I study. Serious adverse events deemed related to the study treatment arose in 14.4% of patients receiving the combo treatment and 10% of Keytruda-only comparators.
“This is the first demonstration of efficacy for an mRNA cancer treatment in a randomized clinical trial,” Kyle Holen, SVP and head of development, therapeutics and oncology at Moderna told BioSpace.
“It is also a benefit above what has been observed with checkpoint inhibitors in this disease, the first therapy of any kind to do so,” Holen added.
Based on these data, the powerhouse partners plan to engage regulatory authorities in preparation for a Phase III study, set to launch next year.
Moment of Truth for Moderna’s mRNA Platform
Discovered and developed using Moderna’s proprietary platform, mRNA-4157/V940 is designed to be a personalized cancer vaccine.
The investigational shot can code for up to 34 neoantigens produced based on the unique genetic mutations of a patient’s tumor. Once inside the body, the neoantigen sequences are translated, helping the immune system target cancer cells more efficiently.
Merck first bought into Moderna’s mRNA technology in 2016, and in October, the partners announced they were moving forward with mRNA-4157/V940.
As the demand for coronavirus vaccines wanes, Moderna is looking for ways to expand its mRNA technology into other therapeutic areas, ensuring its success remains sustainable.
“That’s one of the beauties of the mRNA technology – it has a lot of applications,” Margery Fischbein, managing director of the healthcare practice at investment bank Cassel Salpeter & Co., said in a September interview with BioSpace.
Capitalizing on this diversity, Moderna is advancing a pipeline of more than 40 vaccines and therapeutics. Aside from COVID-19 and cancer, the company also has developed shots for flu, RSV, cytomegalovirus, the Zika virus and HIV.
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