"As for side effects, the companies reported that little had changed from previous analyses; adverse events were similar between the two groups. The top side effects linked to the vaccine were fatigue, injection site pain, and chills. The results "highlight the potential of a prolonged benefit" of the vaccine combined with Keytruda in patients with high-risk melanoma," Kyle Holen, a senior vice president at Moderna, said. They also "illustrate mRNA's potential in cancer care," he said, noting that the company has eight more Phase 2 and Phase 3 trials going for mRNA vaccines against a variety of other cancers, including lung, bladder, and kidney cancers."
"Marjorie Green, a senior vice president at Merck, called the five-year follow-up data a "meaningful milestone" and "encouraging." "[W]e 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. While the top-line results appear positive, conclusions can't be drawn until the full data from the trial are published."
107 participants received the mRNA vaccine plus Keytruda and 50 received Keytruda alone. At two years, 24 of 107 (22%) in the vaccine-plus-Keytruda group had recurrence or death versus 20 of 50 (40%) in the Keytruda-only group, a 44% risk reduction. The three-year and five-year follow-ups reported a 49% risk reduction, though the five-year group breakdown was not provided. Adverse events were similar between groups; top vaccine-linked effects were fatigue, injection site pain, and chills. Additional Phase 2 and Phase 3 trials are ongoing targeting multiple tumor types.
Read at Ars Technica
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