An experimental drug custom-made to target the genetic mutations of individual tumors showed promise in treating aggressive skin cancer, according to new results from a clinical trial announced Tuesday.
The personalized cancer drug is based on the same technology as the leading coronavirus vaccines that helped end the pandemic: sending instructions to the immune system using doses of messenger RNA.
But while people received the same vaccine against a common enemy in the case of coronavirus, scientists are using a personalized approach against cancer based on individual gene mutations.
In combination with an approved immunotherapy, the mRNA drug cut the risk of recurrence or death nearly in half after five years compared with melanoma patients who got only the immunotherapy, drugmaker Moderna said Tuesday.
Moderna is developing the drug, called intismeran autogene, in partnership with Merck, which makes Keytruda, the immunotherapy used in the trial.
“Today’s results highlight the potential of a prolonged benefit of the intismeran autogene and Keytruda combination,” Kyle Holen, a Moderna senior vice president, said in a statement.
The ongoing clinical trial is evaluating the combination in 157 patients with melanoma that has spread after having the cancer surgically removed. Participants receive either the experimental treatment or Keytruda alone for about a year. The results were virtually identical with an earlier analysis published after three years of patient data, which showed the combination reduced the risk of recurrence or death by 49 percent.
Moderna said Tuesday that the safety of intismeran “remains consistent” with its previous reports, which have noted that the number of serious reactions were comparable to patients who received only Keytruda. The most commonly reported side effects related to intismeran were fatigue, pain at the site of injection, and chills, the drugmakers disclosed in December 2023.
Intismeran is tailored to individual patients, a process that begins by analyzing the DNA of a tumor to identify its unique mutations. The therapy then uses mRNA to deliver instructions to the body’s immune cells to help them recognize and attack the cancer cells based on their genetic signature. Keytruda, given by infusion, helps keep the body’s immune cells active in finding and killing cancer cells.
Melanoma is the deadliest form of skin cancer. The National Cancer Institute estimates there were more than 100,000 new cases last year, with a five-year survival rate of about 95 percent. But that rate plummets to about 35 percent when melanoma has spread to other parts of the body, as is the case for some participants in the clinical trial.
Moderna and Merck are running a larger clinical trial evaluating the intismeran-Keytruda combination, with financial analysts expecting results later this year.
Myles Minter, a William Blair analyst, wrote in a note to clients Tuesday that intismeran showed an “impressive effect” over taking Keytruda alone, calling it a “signal of durable tumor control” but cautioning that it is hard to draw conclusions until the drugmakers present the full data from the trial.
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