Biotech Values

[DewDiligence]

MRNA/MRK report_updated phase-2b data_for mRNA-4157 cancer vaccine in_resected_Stage-III/IV melanoma:

https://www.accesswire.com/870288/moderna-merck-announce-three-year-data-for-mrna-4157-v940-in-combination-with-keytruda-pembrolizumab-demonstrated-sustained-improvement-in-recurrence-free-survival-distant-metastasis-free-survival-versus-keytruda-in-patients-with-high-risk-stage

• At a median planned follow-up of the Phase 2b study at 34.9 months, mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 62% compared to KEYTRUDA alone in these patients

• The 2.5-year recurrence-free survival rate of mRNA-4157 (V940) in combination with KEYTRUDA was 74.8% as compared to 55.6% for KEYTRUDA alone, with the benefit observed across exploratory subgroups

• The companies have initiated Phase 3 studies in patients with high-risk melanoma and non-small cell lung cancer, in addition to Phase 2 studies in patients with renal cell carcinoma and urothelial carcinoma and a Phase 2/3 study for cutaneous squamous cell carcinoma

MRK/MRNA reported in Dec 2022 that this phase-2b trial (KEYNOTE-942) met its primary endpoint of DFS with an impressive HR of 0.56 (#msg-170681303). The companies reported even better data (HR=0.51) in Apr 2023 after a median follow-up of 23-24 months (#msg-171699261, #msg-171699374). The data reported today are based on the same patient pool approximately one year later (median follow-up of 35 months) with HR for DFS remaining 0.51.

MRNA says the FDA may consider mRNA-4147 for accelerated approval in melanoma based on the above phase-2b data when MRNA’s new manufacturing facility for this product in Marlborough, MA comes online.