the potential of mRNA
Previous data from the trial reported that 107 participants received the mRNA vaccine and Keytruda treatment, while the remaining 50 received Keytruda alone. At the two-year follow-up, 24 of 107 (22 percent) who received the investigational vaccine and Keytruda had a recurrence or death, while 20 of 50 (40 percent) treated with Keytruda alone had a recurrence or death, indicating a 44 percent risk reduction. The companies did not report the breakdown of the two groups in this week's press release for the five-year follow-up, but said the risk reduction was 49 percent, which is also what the companies reported for the three-year follow-up.
In terms of side effects, the companies reported that little had changed from previous analyses; side effects were similar between the two groups. The main side effects associated with the vaccine were fatigue, injection site pain and chills.
The results “highlight the potential for long-lasting benefit” of the vaccine in combination with Keytruda in patients with high-risk melanoma,” said Kyle Holen, senior vice president at Moderna.
They also “illustrate the potential of mRNA in cancer care,” he said, noting that the company has eight more Phase 2 and Phase 3 trials for mRNA vaccines against a variety of other cancers, including lung, bladder and kidney cancer.
Marjorie Green, a senior vice president at Merck, called the five-year follow-up data a “meaningful milestone” and “encouraging.”
“[W]We look forward to late-stage data from the INTERpath clinical development program with Moderna, across a range of tumor types where significant unmet needs remain,” she said.
Although the top results appear positive, no conclusions can be drawn until the full data from the study is published. The vaccines are also being developed in a political climate hostile to mRNA vaccines. Anti-Vaccine Health Secretary Robert F. Kennedy Jr. has spoken out against mRNA COVID-19 vaccines and made false claims about their safety and efficacy. In August, Kennedy unilaterally canceled $500 million in grant funding for the development of mRNA-based vaccines against diseases that pose pandemic threats.
