Promising Results for mRNA Cancer Vaccine from Moderna and Merck

Bancel says that Moderna is also exploring using intismeran alone, perhaps in earlier stage cancers. For the current trial, because intismeran is still an experimental therapy under study, and an approved therapy, Keytruda, does exist for melanoma patients, regulators at the FDA were more comfortable with combining the drugs so every patient received at least the standard of care and therefore would not be additionally harmed by joining the study. “It would be unethical for us to tell people to come on a study of something that we don’t know if it works, when people are fighting for their lives,” he says. “That’s why we did the study together with Keytruda, which can improve outcomes, and we tried to show that the combination was better, and we did.”

Bancel’s teams are already studying intismeran in stage 1 lung cancer, to see if using it earlier, and priming the immune system, can lead to equally beneficial outcomes for those people. In lung cancer, standard treatment involves surgery and careful monitoring for any signs of returning cancer, so doctors can ethically study how adding intismeran for some patients affects their cancer outcomes compared to those not receiving it. While that study is still in early stages, Bancel is optimistic since “from a scientific standpoint there is no scientific sense that it would work in melanoma and not work in another tumor type,” he says of the mRNA-based approach. “I think it will be transformational. Think about if you get a screening X-ray and find stage 1 lung cancer. Then you get intismeran, which is like a vaccine so you have no severe toxicity like with other immunotherapy. Think about getting this product on your way to work, or even [potentially] at your local pharmacy—that would be an incredible change in care. And it can help reduce the risk of metastasis, and have a profound impact on patients, as well as prevent people from getting very severe disease.”