A phase 3 trial shows that an experimental mRNA vaccine combined with Keytruda reduces the risk of recurrence or death in high-risk melanoma patients compared to Keytruda alone.
Key facts
- •The trial met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival.
- •Intismeran is an investigational treatment and has not yet been approved by the FDA.
- •Previous phase 2b results indicated a 49% lower risk of recurrence or death and a 59% lower risk of distant metastasis or death with the combination therapy.
- •The vaccine is manufactured individually for each patient based on their specific tumor mutations.
- •Researchers emphasize the need for more data regarding the durability of the benefit and the frequency of potential toxicities.
Moderna and Merck announced on August 19 that their experimental personalized mRNA cancer therapy, intismeran, met primary and secondary endpoints in a phase 3 trial. When combined with the immunotherapy drug Keytruda, the vaccine demonstrated a reduction in the risk of melanoma recurrence, death, or distant metastasis in patients with high-risk, resected stage IIB-IV melanoma.
By the numbers
How the Treatment Works
Intismeran is a custom-made vaccine tailored to the unique mutational 'fingerprint' of a patient’s tumor. By sequencing a patient's tumor DNA, the vaccine encodes up to 34 patient-specific neoantigens to train T cells to recognize and target cancer cells. Keytruda acts as a PD-1 checkpoint inhibitor, which helps the immune system identify and attack those cells. Together, the treatment is designed to both release the brakes on the immune system and provide specific directions to locate the cancer.
Next Steps and Expert Perspective
While the phase 3 results are considered encouraging, Moderna and Merck have not yet released detailed efficacy or safety data. The trial remains ongoing, and the companies plan to submit findings to regulatory authorities and present full results at an upcoming medical meeting. Medical experts note that while the findings are a landmark moment, further data is required to assess the magnitude of the clinical benefit and potential safety risks, such as immune-related adverse events.
Advertisement
This article was independently rewritten by ManyPress editorial AI from reporting originally published by Healthline.
