An experimental personalized vaccine has reduced the risk of melanoma recurrence or death when combined with immunotherapy, according to Phase 3 trial results announced by Merck and Moderna. The mRNA-based vaccine, Intismeran Autogene, lowered that risk by 42 percent compared with pembrolizumab alone in patients who had surgery to remove high-risk melanoma.
Trial results
Georgina Long, medical director of the Melanoma Institute of Australia and principal investigator of the study, described the findings in a statement. The researchers called the results “transformative” and said they “could lead to fundamental changes in the way patients with early-stage melanoma are treated.”
The INterpath-001 trial enrolled 1,137 patients with high-risk melanoma after surgery had completely removed their tumors. Participants were divided into two groups. One received pembrolizumab alone, a drug that helps the immune system detect and attack cancer cells. The other received pembrolizumab in combination with Intismeran Autogene, an mRNA vaccine tailored to the individual patient.
After an average follow-up period of 24.6 months, the researchers found that adding the vaccine reduced the risk of cancer recurrence or death by 42 percent compared with pembrolizumab alone.
The combination also reduced the risk of the cancer spreading to other parts of the body by 38 percent. At the end of the follow-up period, 82.2 percent of patients who received both treatments had no recurrence, compared with 70 percent of those who received pembrolizumab alone.
A personalized immune response
“The results of the INterpath-001 study represent a major advance in the treatment of melanoma, especially in the development of personalized medicine,” said Eva Muñoz Cucero, who leads the melanoma research group at Barcelona’s Valdegebron Tumor Institute and was not involved in the study, according to SMC Spain.
“The Phase III trial demonstrated for the first time that a personalized therapeutic vaccine designed based on the molecular characteristics of each patient’s tumor can significantly improve the outcomes of traditional immunotherapy,” Muñoz Cucero said.
The vaccine was developed using tumor samples collected from each patient. Researchers analyzed the samples to identify specific mutations that produce distinct proteins the immune system could recognize and target on cancer cells. Scientists selected up to three of these molecular signatures for each patient.
Source: www.wired.com