Merck and Moderna announced on Wednesday that a study involving a personalized mRNA vaccine combined with the immunotherapy drug Keytruda has shown promise in reducing skin cancer recurrence and spread compared to using Keytruda alone. This marks the first positive late-stage trial outcome for an mRNA cancer vaccine.
The trial, named Intismeran, is still ongoing, but interim results have indicated that the treatment successfully achieved its primary goal of reducing cancer recurrence and its secondary objective of preventing cancer spread to other parts of the body.
Dr. Lennard Lee, a consultant medical oncologist and associate professor at Oxford, commented on the significance of these findings, noting that this is the first positive Phase 3 trial of a treatment that combines immunotherapy with mRNA technology. Lee emphasized the importance of these results in advancing cancer treatment options.
While acknowledging the progress, Lee pointed out that key information such as the magnitude of the Phase III benefit, detailed subgroup analyses, quality-of-life data, and mature overall-survival results are still pending. These details are crucial for the scientific and clinical community to understand the full impact of the treatment and its potential placement in melanoma care protocols.
Merck and Moderna stated that they will be presenting their findings at an upcoming medical conference and will share the results with regulatory authorities.
Melanoma Canada CEO Falyn Katz also expressed optimism about the results, highlighting the potential of personalized mRNA therapy in offering a new and effective way to prevent melanoma recurrence and metastasis for high-risk patients.
The treatment involves combining Merck’s Keytruda with a tailor-made mRNA vaccine from Moderna, designed based on the genetic mutations present in individual patients’ tumors. This innovative approach utilizes messenger RNA technology to train the immune system to recognize and target cancer cells carrying specific abnormal proteins known as neoantigens.
The trial enrolled 1,137 high-risk patients with Stage 2B-4 melanoma who had undergone surgical removal of the tumors. Participants were randomly assigned to receive either up to nine doses of Keytruda in conjunction with the personalized vaccine or Keytruda alone for approximately a year. The companies reported no new safety concerns arising from the trial.
Earlier in January, the companies released findings from a mid-stage trial indicating a 49% reduction in the risk of cancer recurrence or mortality after five years with this combined treatment.
Following the announcement, Moderna’s stock surged by over 150% in mid-morning trading, while Merck’s shares saw an increase of more than 10%.
Melanoma remains a significant health concern in Canada, with an estimated 11,300 new cases expected this year and around 1,250 projected deaths from the disease. Melanoma Canada highlights that melanoma is prevalent among Canadians aged 15 to 49. In the United States, the National Cancer Institute reported over 1.5 million individuals living with melanoma in 2023.
