A new injectable therapy has shown significant promise in reducing the risk of melanoma recurrence or death by nearly 50% over a five-year period. The personalized mRNA cancer vaccine, called intismeran autogene, combined with the immunotherapy drug KEYTRUDA (pembrolizumab), was developed through a collaboration between Merck and Moderna. The findings from the phase 2b KEYNOTE-942 study were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on May 27.
The study analyzed data from 157 patients with high-risk stage 3 and 4 melanoma whose cancer had been surgically removed. Participants were divided into two groups: one received the combination therapy, while the other received only pembrolizumab. After a five-year follow-up, the combination therapy reduced the risk of melanoma recurrence or death by 49% compared to pembrolizumab alone.
The therapy is designed to teach the immune system to recognize and attack cancer by using mutations identified in a patient’s own tumor. Researchers described the treatment as well-tolerated with a manageable safety profile. Common side effects included fatigue, injection-site pain, chills, fever, and headache. No severe vaccine-related adverse events were reported.
The combination therapy is currently being evaluated in a phase 3 study, the final confirmation stage. According to Kyle Holen, MD, Moderna’s senior vice president and head of development, oncology and therapeutics, the data highlights the potential for a prolonged benefit in patients with resected high-risk melanoma.