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Moderna and Merck say mRNA melanoma vaccine cut death or recurrence risk by 42%

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Moderna and Merck say mRNA melanoma vaccine cut death or recurrence risk by 42%

Merck and Moderna announced on Thursday that their personalized mRNA vaccine against melanoma, the deadliest form of skin cancer, reduced the risk of death or recurrence by 42 percent compared to standard treatment in a late-stage trial. The figure is a relative reduction, and it covers death or recurrence combined.

The Phase 3 trial included 1,137 patients with stage IIB to IV melanoma whose tumors had been surgically removed before they entered the trial. Patients were randomized 2-1 to receive either a combination treatment that included the personalized mRNA vaccine plus a standard treatment, or the standard treatment alone. The standard treatment was Merck's established monoclonal antibody cancer treatment Keytruda.

The announcement followed a messy sequence. In August, Moderna and Merck had said the vaccine succeeded in the trial but held back details until the data could be presented at a scientific conference. That conference is the European Society of Medical Oncology meeting, which is starting in Madrid, Spain. The data was scheduled for presentation on Saturday. But an oncology news site reported the results early, breaking the embargo, and the companies then released the top-line results. The full data has been accepted for publication in the New England Journal of Medicine.

Ars Technica calls the results a significant advance in melanoma treatment and says Merck and Moderna are already engaging with regulatory authorities to get the vaccine approved. More broadly, it says the success bolsters hope that mRNA vaccines and individualized cancer-targeting medicines offer a new paradigm for cancer therapies.

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

Key facts

  • A personalized mRNA melanoma vaccine combined with Keytruda reduced the risk of death or recurrence by 42 percent versus standard treatment alone, according to Merck and Moderna.
  • The Phase 3 trial enrolled 1,137 patients with stage IIB to IV melanoma that had been surgically removed, randomized 2-1 to the vaccine combination or standard treatment alone.
  • The standard treatment was Merck's monoclonal antibody Keytruda.
  • Top-line results came out after an oncology news site broke the embargo ahead of a Saturday presentation at the European Society of Medical Oncology meeting in Madrid.
  • The full data has been accepted by the New England Journal of Medicine, and the companies are already engaging with regulatory authorities.

Why it matters

Melanoma is described as the deadliest form of skin cancer, and this is a late-stage trial, not an early signal. Ars Technica calls the result a significant advance in melanoma treatment. It also says the success bolsters hope that mRNA vaccines and individualized cancer-targeting medicines could be a new paradigm for cancer therapy. The treatment is built around each patient's own tumor, which is the idea Moderna's CEO says the company has pursued from the beginning.

Who it affects

The trial population is patients with stage IIB to IV melanoma whose tumors were surgically removed before treatment. They are the group the 1,137-patient trial studied. The result also matters to Merck, whose Keytruda is the standard treatment and the backbone of the combination, and to Moderna, whose CEO frames the data as a defining moment for mRNA in cancer.

How to use it

This is not something readers or clinicians can use yet. Merck and Moderna say they are already engaging with regulatory authorities to get the vaccine approved. The full data has been accepted for publication in the New England Journal of Medicine and is due to be presented at the European Society of Medical Oncology meeting in Madrid.

How solid is it

The 42 percent figure comes from the companies' announcement of top-line results, not from the full published data. The trial was Phase 3 with 1,137 patients and a standard-treatment comparator, and the full data has been accepted by the New England Journal of Medicine, though it is not stated as published. The source gives no hazard ratio, confidence interval or p-value, no absolute event rates or survival numbers, and no follow-up duration. The 42 percent is a relative reduction for death or recurrence combined, and the source does not give separate figures for each.

Risks and caveats

The source reports no safety or side-effect data, so the balance of benefit and harm cannot be judged from it. The only voice quoted is Moderna's CEO, and no Merck executive is quoted. The source does not give a regulatory filing date, an approval timeline or the names of regulators. The results also reached the public through a broken embargo, so the companies released top-line numbers before the planned conference presentation.

“From the beginning, we believed mRNA technology could make it possible to develop cancer treatments uniquely matched to each patient’s tumor”

— Stéphane Bancel, Moderna CEO, in a statement