Moderna and its partner Merck reported that a Phase 3 clinical trial for an experimental mRNA melanoma vaccine showed a statistically significant improvement in keeping patients cancer-free. The trial involved more than 1,100 participants with advanced-stage melanoma. Following the announcement, Moderna's stock value more than doubled on a Wednesday morning.
The treatment process involves removing a piece of a patient's tumor to identify unique genetic mutations. Scientists use artificial intelligence to determine which mutations to include in a personalized vaccine. This synthetic mRNA is then injected into the patient, where it instructs cells to build a protein that trains the immune system to recognize and attack melanoma cells.
In the clinical trial, all participants had their tumors surgically removed and received Keytruda, a standard immunotherapy drug produced by Merck. A portion of the group also received the experimental mRNA vaccine. The results indicated that the group receiving the combination of the vaccine and Keytruda remained cancer-free for a longer period compared to those who did not receive the vaccine.
A patient would experience this treatment as a multi-step medical process: first undergoing surgery to harvest tumor tissue, followed by a waiting period while artificial intelligence and scientists manufacture a custom vaccine specific to their tumor's genetic sequence. The vaccine is designed to work alongside existing drugs like Keytruda, which functions by removing the "cloak of invisibility" cancer uses to hide from the immune system. If successful, this could change the day-to-day management of advanced skin cancer from standard immunotherapy to a combination of immunotherapy and personalized mRNA shots.
The success of this Phase 3 trial establishes a precedent for using mRNA technology—previously best known for its role in COVID-19 vaccines—to treat non-infectious diseases like cancer. This could influence future federal policy regarding how personalized medicines are approved and regulated. The next step for the vaccine is a formal review by the Food and Drug Administration (FDA), which is the final regulatory hurdle before the treatment can be made commercially available to the public. A specific date for the FDA review was not reported.