mRNA efficiency
Previous data from the trial showed that 107 participants received the mRNA vaccine and Keytruda treatment, while the remaining 50 received only Keytruda. At two-year follow-up, 24 of 107 (22 percent) who received the experimental vaccine and Keytruda had recurrence or death, while 20 of 50 (40 percent) treated with Keytruda alone had recurrence or death, indicating a 44 percent risk reduction. The companies did not report a breakdown of the two groups for the five-year follow-up in a press release this week, but said the risk reduction was 49 percent, which was higher than what the companies also reported for the three-year follow-up.
As far as side effects are concerned, the companies reported little change from previous analyses; Adverse events were similar between the two groups. The top side effects associated with the vaccine were fatigue, pain at the injection site and chills.
The results “highlight the potential for long-term benefit” of the vaccine combined with Keytruda in patients with high-risk melanoma, said Kyle Hollen, senior vice president at Moderna.
They also “demonstrate the potential of mRNA in cancer care,” he said, noting that the company is conducting eight more Phase 2 and Phase 3 trials for mRNA vaccines against several other cancers, including lung, bladder and kidney cancer.
Merck senior vice president Marjorie Green 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 for a variety of tumor types where significant unmet needs exist,” he said.
While the top-line results appear positive, conclusions cannot be drawn until full data from the trial is published. Vaccines are being developed even amid an unfavorable political environment towards mRNA vaccines. Anti-vaccine Health Secretary Robert F. Kennedy Jr. has criticized mRNA COVID-19 vaccines for making 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 a pandemic threat.
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