Monday, Moderna Inc ( MRNA )  and Merck & Co Inc ( MRK ) announced the first presentation of results from a planned analysis from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study.

The study is evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with Merck’s Keytruda in patients with resected high-risk melanoma (stage III/IV) following complete resection (n=157).

With a median follow-up of approximately three years (34.9 months), adjuvant treatment with mRNA-4157 (V940) in combination with Keytruda continued to demonstrate a clinically meaningful and durable improvement in recurrence-free survival (RFS), the primary endpoint of the study, reducing the risk of recurrence or death by 49% compared with Keytruda alone.

mRNA-4157 (V940) in combination with Keytruda also continued to demonstrate a meaningful improvement in distant metastasis-free survival (DMFS), a key secondary endpoint of the study, compared with Keytruda alone, reducing the risk of developing distant metastasis or death by 62%.

The 2.5-year recurrence-free survival rate of mRNA-4157 (V940) combined with Keytruda was 74.8%, compared to 55.6% for Keytruda alone, with the benefit observed across exploratory subgroups.

The exploratory endpoint of overall survival (OS) favored mRNA-4157 (V940) in combination with Keytruda compared to Keytruda alone, with a 2.5-year OS rate of 96.0% vs. 90.2%, respectively.

The safety profile with mRNA-4157 (V940) in combination with Keytruda remains consistent with the primary analysis.

Merck ( MRK ) and Moderna ( MRNA ) have initiated Phase 3 trials evaluating mRNA-4157 (V940) in combination with Keytruda as an adjuvant treatment in patients with resected high-risk (Stage IIB-IV) melanoma and non-small cell lung cancer. Both trials are actively enrolling.

In 2024, Merck ( MRK ) and Moderna ( MRNA ) also initiated a two-part Phase 2/3 trial evaluating mRNA-4157 in combination with Keytruda as neoadjuvant and adjuvant treatment in patients with resectable locally advanced Stage II-IV (M0) cutaneous squamous cell carcinoma.

Price Action: At the last check on Monday, MRK shares were up 2.49% at $128.66, and MRNA shares were up 4.62% at $149.11.