Moderna and Merck announced Tuesday promising results in their preliminary trials (Phase 2b) of a skin cancer vaccine. The companies found that combining mRNA technology (the basis for Moderna’s Covid-19 vaccine) and Merck’s drug Keytruda offers better results than administering the drug alone. According to the firms, the combination reduces the risk of recurrence or death by 44%.
This is an early phase trial that has not been published in scientific journals or reviewed by independent experts. While it is too early to draw conclusions, the results show the progress in how messenger RNA technology is being applied to treat multiple diseases. Merck and Moderna plan to discuss the results with regulatory authorities and start a Phase 3 clinical trial in patients with melanoma in 2023. This study will test whether the vaccine is effective or not.
RNA acts as an important messenger in human cells: it carries the instructions for making proteins that allow the body to carry out vital functions. The technique used in this trial, which provokes an immune response through messenger RNA, is the one that was later used to develop vaccines against Covid-19. The mRNA vaccines against the coronavirus use the body’s cells as bioreactors to produce copies of the coronavirus spike protein, which are then located by the immune system.
Moderna is now using mRNA technology to develop drugs that could treat and prevent infectious diseases such as influenza and HIV, as well as autoimmune and cardiovascular diseases and rare forms of cancer, although there have been no conclusive results so far.
As early as 2017, a team led by Uğur Şahin, the founder of BioNTech, the German company which teamed up with Pfizer to create a Covid-19 vaccine, was developing vaccines that targeted up to 10 mutations in 13 melanoma patients. Just as in the Merck and Moderna trial, the researchers combined the vaccine with an anti-PD1 therapy, the name given to checkpoint inhibitor anticancer drugs. Several of them experienced improvements, and one of them even saw their tumor disappear.
Personalized cancer vaccines are designed to prepare the immune system, so that the patient can generate a tailored antitumor response specific to their type of mutation.
“Today’s results are highly encouraging for the field of cancer treatment. mRNA has been transformative for Covid-19, and now, for the first time ever, we have demonstrated the potential for mRNA to have an impact on outcomes in a randomized clinical trial in melanoma,” said Stéphane Bancel, Moderna’s Chief Executive Officer, in a statement. “We will begin additional studies in melanoma and other forms of cancer with the goal of bringing truly individualized cancer treatments to patients. We look forward to publishing the full data set and sharing the results at an upcoming oncology medical conference, as well as with health authorities.”
“These positive findings represent an important milestone in our collaboration with Moderna,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “Over the last six years, our teams have worked closely together combining our respective expertise in mRNA and immuno-oncology with a focus on improving outcomes for patients with cancer. We look forward to advancing this program into the next phase of development.”
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