ASCO 2023: Moderna and MSD’s vaccine/IO combo reduces chances of melanoma spreading

Source: Pharmaceutical Technology, June 2023

Moderna and MSD revealed an update on results demonstrating an improved distant metastasis-free survival (DMFS) when their mRNA vaccine was used in combination with Keytruda (pembrolizumab), at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

In the KEYNOTE-942 study, the jointly developed mRNA-4157 vaccine (V940), an individualised therapy based on the patient’s tumour DNA, reduced the risk of distant metastasis or death in patients with high-risk stage III/IV melanoma by 65% (HR=0.347 [95% CI, 0.145-0.828]) when used in combination with Keytruda, compared to Keytruda alone. Reported adverse events and safety profile were consistent with previous findings.

Results from the ongoing randomised, open-label Phase IIb trial (NCT03897881), first announced in December 2022, have been promising enough for the US Food and Drug Administration (FDA) to grant breakthrough therapy designation and the European Medicines Agency (EMA) to award a priority medicines (PRIME) designation for the combination therapy. The two companies plan to initiate a Phase III study investigating the combination as an adjuvant therapy for patients with high-risk melanoma in 2023.