The effort is the first to show that a cancer vaccine using messenger RNA may be effective.
After surgery and as long as a year on the pair of drugs, melanoma patients in the trial saw a 44 percent reduced risk of recurrence or death compared with patients who received Keytruda alone, according to the announcement. The companies did not release the results of the study itself, which have not yet been independently reviewed.“Today’s results are highly encouraging for the field of cancer treatment,” Stéphane Bancel, Moderna’s chief executive, said in a news release.
Bancel said the full data from the melanoma study would be shared with health authorities, including the Food and Drug Administration, and released at a medical conference. The phase 2b trial involved 157 patients with Stage 3 or 4 melanoma that had spread to a lymph node and who faced a high risk of recurrence. The patients were split randomly into two groups.
Positive results in a larger phase 3 trial would be required before the FDA would consider allowing the drug combination on the market. The companies said they hope to begin that trial next year.technology, Moderna’s proposed vaccine employs a “personalized” approach designed to prompt a patient’s immune system to attack the specific mutations of his or her tumors.
Francis S. Collins, former director of the National Institutes of Health, said in an interview last week that development of vaccines for cancer using mRNA technology may be one of the great medical advances to come out of the pandemic. “Cancer vaccines have had a lot of promise, but they have been really not quite taking hold because the cycle time was just too long. … Now with mRNAs, you can do that so much more quickly,” he said.
“Serious adverse events” related to the Moderna and Merck treatments occurred in 14.4 percent of patients who received the drug combination and 10 percent of those who received Keytruda alone.in the United States and 8,199 died, according to the Centers for Disease Control and Prevention. The five-year survival rates of the disease are estimated at 60.3 percent for Stage 3 and 16.2 percent for Stage 4, according to the companies.
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