The experimental personalized cancer vaccine, developed by Moderna and Merck, has yielded positive results in its first Phase 3 trial, bringing the therapy closer to a potential application for regulatory approval.
The mRNA technology vaccine, combined with the immunotherapy Keytruda, was tested in more than 1,100 patients with high-risk or advanced melanoma whose tumors had been surgically removed.
According to results released by the companies, combining the vaccine with Keytruda significantly extended the time patients remained free of melanoma compared to treatment with Keytruda alone. The therapy also reduced the risk of the disease spreading to other parts of the body.
The vaccine is personalized for each patient. It is designed to target specific mutations in an individual's tumor, with the goal of teaching the immune system to recognize and attack the cancer cells. Keytruda, meanwhile, helps boost the immune response.
The companies are expected to present the results at an upcoming medical conference.
The study will continue to assess overall survival, and it has not yet been announced when applications for approval in the US will be submitted.
Merck called the results a clinically meaningful improvement over Keytruda alone. According to the company, the side effects observed were generally similar to those associated with routine vaccines.
If the results are confirmed and the treatment receives regulatory approval, the combination could represent an important step towards the use of personalized mRNA vaccines in cancer treatment and pave the way for similar trials in other tumor types.