On Monday, Merck & Co Inc ( MRK ) and Moderna, Inc. ( MRNA ) announced the initiation of INTerpath-009, a pivotal Phase 3 trial of V940 (mRNA-4157).

V940 is an investigational individualized neoantigen therapy under development in combination with Keytruda (pembrolizumab) as adjuvant treatment for resectable Stage II, IIIA or IIIB (N2) non-small cell lung cancer (NSCLC) patients who did not achieve a pathological complete response (pCR) after receiving neoadjuvant Keytruda plus platinum-based chemotherapy.

Global recruitment in INTerpath-009 has begun, and the first patients have started enrolling in Canada.

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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 (INTerpath-001) and non-small cell lung cancer (INTerpath-002).

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 for resectable locally advanced Stage II-IV cutaneous squamous cell carcinoma (INTerpath-007), a Phase 2 trial of mRNA-4157 (V940) plus Keytruda as adjuvant treatment for intermediate-high-risk, high-risk, or M1 no evidence of disease renal cell carcinoma (INTerpath-004), and a Phase 2 trial of mRNA-4157 plus Keytruda as adjuvant treatment for high-risk muscle-invasive urothelial carcinoma post-radical resection (INTerpath-005).

In June, the companies unveiled the first presentation of results from a planned analysis from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study.

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.

Price Action: MRNA stock is up 2.90% at $54.63 at last check Monday.

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