Moderna announced in April 2023 that the mRNA-4157/V940, which had been granted BTD by the US FDA in February 2023, has been awarded Priority Medicines (PRIME) scheme designation by the EMA. The investigational personalised mRNA cancer vaccine is intended for combination use with Merck’s KEYTRUDA, an anti-PD-1 therapy. This combination treats patients with high-risk stage II/IV melanoma after complete resection.  

Positive results lead to PRIME designation 

As we reported in December 2022, Moderna and Merck shared positive results from a Phase IIb trial. The combination therapy demonstrated a “statistically significant and clinically meaningful improvement” on KEYTRUDA alone. As a result, the FDA granted Breakthrough Therapy Designation in February 2023.  

PRIME is a mechanism by the EMA to provide support for medicines that target an unmet medical need. This support is described by Moderna as “early and proactive”, to optimise the generation of “robust data” and “speed up the development” of the medicine. The next steps will be discussions of the data with regulatory authorities and a plan to initiate a Phase III study this year.  

Potential promise 

Dr Stephen Hoge is Moderna’s President. He described the “high unmet need for therapies in melanoma”, which “can be a life-threatening condition” in which current therapies “may not be sufficiently effective” for many patients.  

“PRIME scheme designation for mRNA-4157/V940 in combination with KEYTRUDA highlights the potential promise of individualised cancer treatments in a population with limited alternatives.” 

Dr Eric H. Rubin, Senior Vice President, global clinical development, at Merck Research Laboratories, agrees that the “milestone underscores the potential” for “personalised approaches” to contribute to the improvement of outcomes for people with “certain types of melanoma”. 

“We look forward to working with the EMA, in collaboration with Moderna, to advance our clinical development programme.”  

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