Following positive results from a Phase IIb trial in December 2022, Moderna and Merck have announced that their personalised mRNA cancer vaccine, in combination with KEYTRUDA, has been granted Breakthrough Therapy Designation by the FDA. In a statement in February 2023, the companies stated “excitement” at the “potential promise of individualised cancer treatments”.  

A new frontier 

As we noted in December, the Phase IIb trial, KEYNOTE-942, produced positive data. The trial enrolled 157 patients with stage III/IV melanoma and compared mRNA-4157/V940 and KEYTRUDA therapy with KEYTRDUA alone for one year.  

Dr Stephen Hoge, Moderna’s President, described the trial as “the first demonstration of efficacy for an investigational mRNA cancer treatment”, which “potentially represents a new frontier in treating melanoma and other cancers”.  

“We look forward to publishing the full data set and sharing the results at an upcoming oncology medical conference, as well as continuing discussions with health authorities. We are grateful to the FDA for this designation.”  

Breakthrough Therapy Designation 

The FDA’s Breakthrough Therapy Designation is intended to “expedite the development and review” of candidates for serious conditions where “preliminary clinical evidence indicates that the product may demonstrate substantial improvement over available therapies on at least one clinically significant endpoint”.  

Both companies will continue working with regulatory authorities and initiate a Phase III study with a view to expanding to additional tumour types.  

Dr Eric H. Rubin, Senior Vice President, Global Clinical Development, Merck Research Laboratories, stated that this was an “important milestone” for the project”.  

“We look forward to working with the FDA, in collaboration with Moderna, to conduct a rigorous and rapid clinical development programme with a focus on addressing the needs of this important patient population”.  

For more from Moderna and Merck and specific tracks devoted to cancer vaccine development, join us at the World Vaccine Congress in Washington this April.