U.S. pharmaceutical companies Moderna and Merck say a clinical trial for an experimental Moderna mRNA vaccine used in combination with the Merck cancer therapy drug Keytruda reduced the chance of recurrence or death from melanoma by nearly 50%.
“As we continue to follow participants in the KEYNOTE-942/mRNA-4157-P201 study, we are excited to see such a robust clinical benefit with mRNA-4157 (V940) as adjuvant treatment in combination with Keytruda in people with resected high-risk melanoma,” Kyle Holen, MD, Moderna senior vice president and head of Development, Therapeutics and Oncology, said in a press release. “These data add another positive analysis to the multiple endpoints and subgroups previously assessed in this study. Importantly for this technology, the KEYNOTE-942/mRNA-4157-P201 study was the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and the first combination therapy to show a significant benefit over Keytruda alone in adjuvant melanoma. We look forward to sharing these data with people impacted by this disease and the broader scientific community.”
In a release from Moderna in December, the company said the trial included 157 patients with high-risk stage III/IV melanoma. Following complete surgical resection of the melanoma, the patients received a combination of either the vaccine and Keytruda — or Keytruda alone — over the course of one year.
After approximately three years, researchers found that patients who received the drugs in combination showed a 49% reduction in the risk of recurrence of the cancer or death, compared to the use of Keytruda alone.
Patients who received the combination also saw a 62% reduction in the chances of the cancer spreading elsewhere in the body.
The Moderna vaccine’s mRNA technology — just as with the company’s COVID vaccine — is designed to train the immune system to recognize and attack specific mutations in cancer cells.
Merck’s Keytruda drug is an immunotherapy that also works in the body’s immune system by increasing its ability to help detect and fight tumor cells.
As a result of the trial, Merck reports, the U.S. Food and Drug Administration has granted Breakthrough Therapy designation for the drug combination, a process designed to expedite the development of the treatment.
Europe’s drug regulator, the European Medicines agency, has granted the treatment a similar designation.
The U.S. Centers for Disease Control and Prevention reports skin cancer is the most common form of cancer in the United States, and melanoma is it most serious form.
The CDC reports that in 2020, the most recent year for which figures are available, 77,230 new cases of melanoma were reported, and 8,214 people died of the cancer.