Merck and Moderna Skin Cancer Vaccine Significantly Reduces Risk of Death

An mRNA vaccine produced by Moderna and Merck reduced the risk of skin cancer metastasis or death by 65%, according to clinical trial results shared at the 2023 session of the American Society of Clinical Oncology. The data collected from the KEYNOTE mRNA clinical trial positions the companies for a stage 3 study later this year.

The mRNA vaccine and Keytruda combination achieved a clinically meaningful improvement in distant metastasis-free survival compared to Keytruda alone, which cut the risk of recurrence or death by 44%. The most common adverse events associated with the trial were fatigue (60.6%), injection site pain (55.8%), and chills (50%).

The investigational therapy, mRNA-4157, is a single synthetic mRNA that codes for 34 neoantigens designed to prepare the immune system to fight tumors. According to the study, combining an mRNA vaccine and Keytruda can potentially improve the T-cell-mediated response to cancer.

"Patients who experience metastases at distant sites typically have worse survival outcomes and a poor prognosis. Thus these results showing a reduction in the risk of distant recurrence underscore the potential of neoantigen therapy," said Kyle Holen, MD, Moderna's SVP and Head of Development, Therapeutics, and Oncology. "These results add to the emerging picture of how individualized neoantigen therapy may transform melanoma treatment and the promise it may hold for other types of cancer.”

After such a promising result from their phase 2a trial, Moderna and Merck are seeking expedited approval from the FDA.

In a recent interview with PharmaNewsIntelligence, Arda Ural, the leader of Ernst & Young’s Health Sciences and Wellness division, explained that RNA-based therapies like Merck and Moderna’s are rapidly gaining popularity and becoming a target for large pharmaceutical companies. Ural also shared that the phase 3 portion of this drug development process is often the most expensive and prone to risk.

Merck and Moderna have been collaborating since 2016, but now, the race is on to find mRNA vaccines that treat cancer. At the Memorial Sloan Kettering Cancer Center, researchers partnered with BioNTech recently published positive results from a phase 1 clinical trial that achieved a response in 50% of patients treated with a pancreatic cancer vaccine. In that trial, 16 patients were dosed with an experimental neoantigen vaccine and another immunotherapy. Half of the patients in the experimental group showed signs of increasing immunity just three days after injection.