Moderna, Merk’s mRNA cancer vaccine shows promising result in trials

File photo of Moderna CEO Stephane Bancel (Image Source: CNBC)

US-based pharma major Moderna on December 14 announced that its investigational mRNA cancer vaccine developed in partnership with Merk’s monoclonal antibody, KEYTRUDA, has shown significant improvement in the rates of recurrence-free survival of high-risk melanoma patients.

According to Moderna, an investigational personalized mRNA cancer vaccine (the mRNA-4157/V940), in combination with Merk’s monoclonal antibody KEYTRUDA, anti-programmed death receptor-1 (PD-1) therapy, helped patients in Stage 3 or Stage 4 Melanoma, reduce the risk of recurrence or death by 44 percent.

“mRNA-4157/V940, in combination with KEYTRUDA, demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death compared to KEYTRUDA monotherapy in stage III/IV melanoma patients with high risk of recurrence following complete resection,” the company said in a statement.

Moderna has claimed that the results from Phase 2 trial are the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial.

Both Moderna and Merck plan to discuss results with regulatory authorities and initiate a Phase 3 study in melanoma in 2023 and rapidly expand to additional tumor types.

"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.

The Moderna CEO said the company will initiate additional studies in melanoma and other forms of cancer with the goal of bringing 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," he added.

Dr. Dean Y. Li, president of Merck Research Laboratories, said the positive findings represent an important milestone in the company’s collaboration with Moderna.

“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,” he added.