49% reduction in cancer risk with mRNA cancer vaccine
(In August, RFK Jr announced $500M in cuts to mRNA vaccine research)
Moderna Cancer Vaccine Maintains 49% Risk Reduction in Five-Year Melanoma Study Follow-up
The companies have an expansive clinical program for the mRNA neoantigen therapy intismeran autogene in combination with immuno-oncology heavyweight Keytruda.
Merck and Moderna’s mRNA neoantigen therapy reduced the risk of recurrence or death in patients with advanced melanoma by nearly half at the five-year mark of a mid-stage trial when paired with Keytruda. The latest results build on the companies’ efforts to develop a long-term solution to the intractable skin cancer that often recurs even after complete removal via surgery.
The data come from an analysis of the Phase IIb KEYNOTE-942/mRNA-4157-P201 study, an open label trial that paired the therapy, called intismeran autogene, with Merck’s immuno-oncology juggernaut. Patients had high-risk stage three or four melanoma and underwent complete resection prior to receiving the treatment combo or Keytruda alone for a year.
In a readout at the three-year mark in December 2023, the combo reduced the risk of recurrence or death by 49% compared to Keytruda alone.
In Tuesday’s release, the companies said that number was the same at the five-year mark. They did not report what Keytruda alone achieved. The study originally reached the primary endpoint in December 2022, achieving a risk reduction of 44%.
Moderna and Merck said in a statement that the data builds on the analyses performed at two years and three years. Safety was consistent with previous readouts.
“While incremental,” William Blair analysts wrote in a note Tuesday morning, “we view today’s 5-year data update on intismeran as positive maintenance of an impressive effect over Keytruda monotherapy, the first therapy, to our knowledge, to show added benefit in this post-surgical setting.”
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