Melanoma Vaccine Cuts Death or Recurrence Risk by 42%
A personalized mRNA shot paired with existing immunotherapy lowered the chance of disease returning in a large late-stage trial, prompting the drugmakers to begin filing for approval.
By Lauren Collins ·
A new mRNA vaccine designed to target each patient's specific melanoma cells lowered the risk of death or disease recurrence by 42% compared to standard care in a late-stage trial, partners Moderna and Merck announced Thursday. The data represents a significant advance in treating melanoma, the deadliest form of skin cancer, and carries broader implications for the pharmaceutical industry. Success in this trial bolsters the argument that mRNA technology and individualized medicines can fundamentally alter how cancer therapies are developed and administered.
The timeline of this announcement involves an attempted embargo that was broken early. In August, the companies revealed that the trial had met its goals but withheld specific statistics, waiting to present the full dataset at the European Society of Medical Oncology conference in Madrid. The presentation was scheduled for Saturday. However, after an oncology news site reported the results ahead of schedule, the companies released the top-line figures. The complete data has been accepted for publication in the New England Journal of Medicine.
The Phase 3 trial involved 1,137 patients diagnosed with stage IIB through IV melanoma who had already undergone surgery to remove the tumor. Participants were randomized in a two-to-one split to receive either a combination regimen consisting of the personalized mRNA vaccine plus standard treatment, or the standard treatment alone. The standard treatment used in the study was Merck's established monoclonal antibody cancer treatment Keytruda.
Moderna CEO Stéphane Bancel stated, "From the beginning, we believed mRNA technology could make it possible to develop cancer treatments uniquely matched to each patient's tumor." He added that the trial results "mark a defining moment for that vision and show what's possible when we rethink how medicines are made." The company expressed confidence that mRNA has the potential to fundamentally change cancer treatment protocols.
The immediate next step involves regulatory engagement. Merck and Moderna are already engaging with regulatory authorities to seek approval for the vaccine. The release of this data marks a defining moment for that vision and shows what is possible when rethinking how medicines are made. The companies are now moving toward regulatory submissions to make the treatment available to patients.
Source: Ars Technica
