A first-of-its-kind vaccine against cancer may be on the horizon.
The drug makers Merck and Moderna announced on Thursday the full results of a closely watched trial of an experimental vaccine given to patients with melanoma. The study found that the patients who received the vaccine after surgery to remove their tumors were 42 percent less likely to have a recurrence of the cancer or to die within two years as those who did not receive the vaccine.
“Everyone is very hopeful that this will be a new way to treat patients with melanoma,” said Dr. Robert Vonderheide, president-elect of the American Association for Cancer Research. He added that the results that were seen in the study are on par with “our biggest breakthroughs.”
The findings of the research were released earlier than planned. They were to have been presented for the first time on Saturday at the European Society for Medical Oncology Congress in Madrid. But the companies lifted an embargo after some of the data were leaked.
The trial involved 1,137 melanoma patients who had their tumors surgically removed and were given an immunotherapy drug called pembrolizumab (Keytruda), which takes the brakes off certain immune cells to attack cancer cells. About two-thirds of the patients were randomly assigned to receive the experimental mRNA vaccine, delivered in nine doses, and the other third were assigned to receive a placebo. The vaccines were personalized to include up to 34, specific “neoantigens,” or new proteins expressed by the patient’s tumor, to stimulate an immune response to those proteins.
Two years after entering the trial, the patients who received the vaccine were far less likely to have had the cancer come back or, worse, have spread far in the body.
“You’ve effectively immunized the body to recognize the cancer and kill it,” said Dr. Marjorie Green, head of oncology clinical development at Merck. “It’s been a dream to do this for a long, long time.”
Dr. Green said the company planned to move forward with applying for regulatory approval as quickly as possible.
Neither the current melanoma trial nor an earlier, Phase 2 trial of the same vaccine has yet demonstrated whether the group that received the vaccine ultimately lived longer. This measure, called overall survival, is the gold standard for determining whether a cancer intervention actually works and can sometimes be a requirement for regulatory approval.
Scientists are studying similar vaccines for a number of other cancers, like pancreatic and brain cancers. But some are skeptical that their success in melanoma, a cancer known to respond well to immunotherapy approaches, will extend to other types of cancer that don’t respond as well to such therapies.
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