In June 2023 Moderna and Merck, who have been collaborating on a Phase IIb study to evaluate mRNA-4157 (V940), announced distant metastasis-free survival (DMFS) results. The trial investigates the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, with an investigational individualised neoantigen therapy (INT) in patients with resected high-risk melanoma (stage III/IV).  

The overall intention-to-treat (ITT) population demonstrated that the combination treatment showed a “statistically significant and clinically meaningful improvement in DMFS”, which was a key secondary endpoint of the study, in comparison with KEYTRUDA alone. The risk of developing distant metastasis or death was reduced by 65%. The data are being presented orally at the American Society of Clinical Oncology Annual Meeting on 5th June 2023.  

Rapidly advancing progress 

Dr Kyle Holen, Moderna’s Senior Vice President and Head of Development, Therapeutics and Oncology, is “excited to be sharing these results with the oncology community”. Dr Holen was “thrilled to see such an exceptional result in distant melanoma or death”. Recognising that patients who experience metastases at distant sites “typically have worse survival outcomes and a poor prognosis”, he suggests that the results “add to the emerging picture” of the transformative potential of individualised neoantigen therapy. 

“Together with Merck, we are rapidly advancing our efforts to move this forward for patients.”  

Dr Eric H. Rubin, Senior Vice President, Global Clinical Development, Merck Research Laboratories, suggests that patients with stage III and IV melanoma can be at “high risk of having their cancer recur or metastasise to other sites”.  

“These new DMFS results build upon the positive recurrence-free survival data previously observed from this Phase IIb study, and we look forward to working with Moderna to initiate a Phase III study in melanoma later this year.” 

As we have previously noted , the results of the trial have resulted in the PRIME scheme award and Breakthrough Therapy Designation. We look forward to hearing future success stories as progress continues. 

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