Breakthrough Personalized mRNA Vaccines Are Highly Effective Against Melanoma Skin Cancers

Pharmaceutical companies Moderna and Merck announced today the highly promising results of their anti-cancer mRNA vaccine Phase 3 clinical trial targeting later-stage melanoma skin cancers.

Researchers sequenced the DNA from each patient’s tumors to create personalized vaccines that, when injected, rev up the immune system to destroy the cancer cells while leaving healthy tissues alone. The versatile mRNA platform enables researchers to manufacture bespoke vaccines for each patient in just six weeks.

Some arms of the clinical trial paired the new mRNA vaccines with Merck’s Keytruda, a monoclonal antibody checkpoint inhibitor that enables immune cells to identify and kill cancer cells.

The patients in the clinical trial had been diagnosed with Stage IIB to Stage IV melanoma cancers. All had visible signs of their tumors surgically removed before beginning the clinical trial. Around 112,000 Americans are diagnosed with melanoma each year, and about 8,500 die of the disease. The five-year survival rate for Stage IIB is around 87 percent, falling to 35 percent for Stage IV patients. In earlier Phase 2b trial results, the vaccine/Keytruda combination reduced the risk of cancer recurrence or death by 49 percent compared to Keytruda alone.

The companies plan to release the full Phase 3 data later this year, but they did note that “the trial met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS).”

“The positive hit here leads us into truly this next phase in immunotherapy,” Karen Knudsen, CEO of the Parker Institute for Cancer ⁠Immunotherapy, told Reuters. “This is an auspicious ​start—this is where things begin.”

Moderna and Merck are pursuing similar mRNA cancer vaccine trials aimed at late-stage lung, kidney, and bladder cancers. The companies believe that the technology can be scaled up commercially. Yahoo Finance reports that Moderna Chief Executive Officer Stéphane Bancel said the product could be approved by regulators as soon as 2027.