New Skin Cancer Vaccine Shows Strong Results

Moderna and Merck reported Thursday that a personalized vaccine targeting melanoma substantially lowered the risk of death or recurrence for patients compared to standard care. In a late-stage clinical trial, the combination of an individualized mRNA vaccine and an established antibody treatment reduced that risk by 42 percent versus the antibody therapy alone. The companies said they are now engaging with regulatory authorities to seek approval for the vaccine.

The trial results represent a significant development in the treatment of melanoma, which is the most lethal form of skin cancer. The companies’ announcement also reinforces the potential for mRNA-based, patient-specific medicines to serve as a new approach to cancer therapy.

“From the beginning, we believed mRNA technology could make it possible to develop cancer treatments uniquely matched to each patient’s tumor,” Moderna CEO Stéphane Bancel said in a statement. He said the trial results “mark a defining moment for that vision and show what’s possible when we rethink how medicines are made.” The results also “reinforce our conviction that mRNA has the potential to fundamentally change how we treat cancer,” he said.

The companies first announced in August that the vaccine had met its primary goal in the trial but withheld detailed results until they could be presented at a scientific conference. The presentation was scheduled for Saturday at the European Society for Medical Oncology meeting in Madrid, Spain. However, after an oncology news website reported the results early, the companies released the top-line data ahead of schedule. The full set of data has been accepted for publication in the New England Journal of Medicine.

The Phase 3 trial enrolled 1,137 patients with stage IIB through IV melanoma whose tumors had been surgically removed before they entered the study. Participants were randomly assigned, with two receiving one treatment for every one assigned to another.

Those assigned to the experimental group received a combination of a personalized mRNA vaccine with Merck’s established monoclonal antibody cancer treatment, Keytruda. The other group received Keytruda alone. The vaccine is designed to be tailored to the specific mutations found in an individual patient’s tumor.

The 42 percent reduction in the risk of death or recurrence was measured against the standard treatment. The companies did not provide further details on the trial’s other findings.

With these results now public, the companies are turning their focus to regulatory submissions. Merck and Moderna are in discussions with health authorities to pursue approval for the vaccine.

The development is being watched closely by the medical community for what it could mean for future cancer therapies. The success of this vaccine in a late-stage trial could influence how other personalized cancer treatments are developed and tested.