A personalized mRNA cancer vaccine developed by Moderna and Merck significantly reduced the recurrence of melanoma when combined with Merck’s blockbuster immunotherapy Keytruda, delivering a major late-stage trial success that could pave the way for a potentially important new cancer treatment, according to Bloomberg.

The large trial met its primary goal, showing that patients receiving the personalized vaccine alongside Keytruda experienced fewer melanoma recurrences than patients treated with Keytruda alone. The combination also achieved a key secondary goal by slowing the spread of cancer to other areas of the body.

The results represent the first positive final-stage trial for any mRNA-based cancer therapy, providing the strongest evidence yet that the technology that became widely known during the COVID-19 pandemic could also successfully be used against cancer.

The companies have not yet disclosed exactly how much the vaccine reduced the recurrence of melanoma, nor have they determined whether patients receiving the vaccine ultimately live longer. Moderna and Merck plan to present the full data at an upcoming medical meeting and discuss the results with regulators. Moderna Chief Executive Officer Stéphane Bancel said the product could potentially be approved as soon as 2027, depending on the trial’s outcome and the regulatory review process.

The treatment is designed individually for each patient. After a tumor is surgically removed, scientists analyze its genetic mutations and use an algorithm to identify which mutations are most likely to produce an immune response. Moderna then manufactures a personalized vaccine specifically tailored to that patient, a process that currently takes several weeks.

Once administered, the vaccine is intended to teach the immune system to recognize proteins associated with the patient’s cancer cells. Keytruda, meanwhile, helps immune cells attack the tumor by blocking a mechanism cancer cells use to evade the immune system.

The latest results build on encouraging earlier findings. Moderna and Merck previously reported that melanoma patients in a mid-stage trial who received the mRNA vaccine together with Keytruda were 49% less likely to die or have their cancer return after five years than patients who received Keytruda alone.

The companies are also testing the approach beyond melanoma. According to Bloomberg, studies are underway in kidney, bladder, and other cancers, with Moderna and Merck hoping the personalized vaccine technology could eventually have applications across multiple types of cancer.

The announcement sent Moderna shares sharply higher. The stock, which had already more than doubled in premarket trading, was up as much as 113%. Merck shares climbed as much as 9.5%.

Melanoma is the most serious form of skin cancer. Roughly 112,000 people are diagnosed with it each year in the United States, with about 8,500 annual deaths.

(YWN World Headquarters – NYC)