Moderna and Merck Report Positive Phase 3 Results for Personalized Cancer Therapy

Melanoma study advances individualized mRNA treatment as companies prepare for regulatory discussions

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Moderna and Merck are advancing an investigational personalized mRNA cancer therapy, intismeran autogene, in combination with Keytruda (pembrolizumab), following positive Phase 3 results in patients with high-risk melanoma. The individualized treatment is designed to help the immune system recognize and attack cancer cells based on characteristics of each patient’s tumor. Image for illustration purposes.
Moderna and Merck are advancing an investigational personalized mRNA cancer therapy, intismeran autogene, in combination with Keytruda (pembrolizumab), following positive Phase 3 results in patients with high-risk melanoma. The individualized treatment is designed to help the immune system recognize and attack cancer cells based on characteristics of each patient’s tumor. Image for illustration purposes. 
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Moderna and Merck have reached a major clinical milestone after their investigational individualized cancer therapy, combined with Merck’s Keytruda, produced positive results in a Phase 3 study involving patients with high-risk melanoma.

Moderna CEO Stéphane Bancel . Image Screenshot Fox News

Moderna CEO Stéphane Bancel discussed the results during an interview with FOX Business, saying the companies are moving quickly toward discussions with regulators while preparing detailed findings for presentation to the medical community.

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The investigational treatment, intismeran autogene, uses mRNA technology to create an individualized therapy based on a patient’s cancer characteristics. It is being studied with pembrolizumab, marketed by Merck as Keytruda, in patients whose melanoma has been surgically removed.

Moderna reported that the Phase 3 study demonstrated a clinically meaningful improvement compared with Keytruda alone in patients with completely resected Stage IIB-IV melanoma. The FDA has not approved the treatment. 

Bancel said the companies expect to present detailed results at an oncology conference and submit them to a medical journal after completing their analysis.

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