A groundbreaking vaccine reduced the risk of death or recurrence of melanoma by almost half, an encouraging signal for a treatment seeking federal approval that has boosted the fortunes of drugmakers Moderna and Merck and could usher in a new wave of cancer treatments.
The drug, intismeran autogene, which uses messenger RNA (mRNA) to deliver a vaccine tailored to the genetic profile of a patient’s cancer tumor, reduced the risk of recurrence or death from melanoma by 42 percent compared to a standard treatment in a Phase 3 clinical trial, Moderna and Merck announced Thursday.
“It sounds incredibly positive,” Karen Knudsen, CEO of the Parker Institute, a nonprofit for cancer therapeutic research and development, said of the results. “This looks like yet more evidence of a well-conducted, meaningful study.”
Intismeran also reduced the risk of melanoma spreading to other parts of the body or death from melanoma by 38 percent, according to the drugmakers. Data on overall survival — how long patients live after receiving a treatment, which is usually assessed over a longer time frame — was not yet available, but investigators observed a “favorable trend,” according to Moderna and Merck.
Side effects of the treatment were consistent with those observed in previous studies, which included fatigue, chills, and pain at the injection site.
“These results reinforce our conviction that mRNA has the potential to fundamentally change how we treat cancer,” Moderna CEO Stéphane Bancel said in a statement.
Moderna and Merck previously announced the trial of intismeran had been successful without sharing the full data from the trial. Researchers are scheduled to unveil the data Saturday at the European Society For Medical Oncology’s annual congress in Madrid, but the data was leaked Thursday, CNBC reported.
Moderna shares dropped by around 25 percent Thursday after the leak, according to CNBC, which some analysts suggested was because of inflated expectations, not issues with the data.
Janice Mehnert, associate director for clinical research at NYU Langone Health’s Pearlmutter Cancer Center and a lead investigator in the trial, called intismeran a “first in class technology.”
Intismeran is produced on a personalized basis for each patient using an analysis of tissue samples from their tumor. The drug uses mRNA, the same platform used to develop the leading covid-19 vaccines, to deliver the customized treatment, which is given alongside an existing immunotherapy medication to boost its effectiveness.
“It was really creative science,” Mehnert said.
Melanoma, the deadliest form of skin cancer, is one of the most common cancer types in the United States, according to the National Cancer Institute, which estimates there will be more than 100,000 new cases this year. It can often recur even after a tumor is surgically removed. Intismeran is intended for patients who have had a melanoma tumor removed.
Moderna and Merck said Thursday that they are “engaging with regulatory authorities” based on the trial data. Moderna President Stephen Hoge told The Washington Post in August the company hoped to move “as fast as possible” in seeking approval from the Food and Drug Administration.
Knudsen said that while data from the trial appeared positive, it is still unclear how quickly the FDA will evaluate intismeran as federal regulators have never weighed in on a cancer vaccine of this kind.
“This is going to be new territory for the FDA,” Knudsen said.
Trials are already underway for other mRNA-based cancer vaccines, and experts said Thursday’s data further supported the promise of the technology. Whether those results can be replicated with other types of cancer remains to be seen. A Phase 2 and 3 trial of an mRNA-based vaccine for head and neck cancer developed by BioNTech failed to meet one of its targets for improving survival, the company announced this month.
Researchers are investigating vaccines for pancreatic, lung and breast cancer, among other trials.
“This is, I do think, a whole new frontier,” Knudsen said.
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