An investigational mRNA vaccine used along with immunotherapy continues to show benefit for people with high-risk forms of the skin cancer melanoma, the drugmakers said Thursday.
At a three-year follow-up with trial participants who had had a stage III or IV melanoma fully removed but were at high risk of the cancer coming back, those who got the vaccine from Moderna and Merck along with Merck’s Keytruda immunotherapy had a 49% lower risk of recurrence or death and a 62% lower risk of distant tumor cell spread or death compared with those who got Keytruda alone, the companies said in a news release.
A two-year follow-up had found a 44% lower risk of recurrence or death and a 65% lower risk of distant metastasis or death in people who got Keytruda and the vaccine, called mRNA-4157/V940, compared with those who got Keytruda alone.
Moderna Chief Executive Officer Stephane Bancel told CNN Thursday that the company is preparing for potential accelerated approval of the individualized therapy as soon as 2025, and is building a new commercial manufacturing plant in Massachusetts to be ready.
The US Food and Drug Administration first approved Keytruda, which boosts the immune system’s ability to detect and fight cancer cells, for treatment of certain cancers in 2014. The agency has granted a breakthrough therapy designation to mRNA-4157/V940 combined with Keytruda, a status that expedites the development and review of drugs that are intended to treat a serious condition and that preliminary clinical evidence indicates may be a substantial improvement over available therapies.