In a significant development for cancer treatment, Merck & Co. Inc. (MRK) and Moderna, Inc. (MRNA) have announced the launch of a pivotal Phase 3 trial for their innovative neoantigen therapy, V940 (mRNA-4157). This trial, named INTerpath-009, aims to evaluate the effectiveness of V940 when used in combination with Keytruda (pembrolizumab) as an adjuvant treatment for non-small cell lung cancer (NSCLC) patients.
The trial specifically targets patients with resectable Stage II, IIIA, or IIIB (N2) NSCLC who did not achieve a pathological complete response (pCR) following neoadjuvant treatment with Keytruda and platinum-based chemotherapy. Global recruitment for INTerpath-009 has commenced, with the first participants enrolling in Canada.
This latest trial builds on the momentum of previous studies exploring V940’s potential as an adjuvant treatment alongside Keytruda for various cancer types. Notably, Merck and Moderna have already initiated Phase 3 trials evaluating V940 in combination with Keytruda for resected high-risk (Stage IIB-IV) melanoma (INTerpath-001) and non-small cell lung cancer (INTerpath-002).
Furthermore, the companies have initiated several other trials in 2024, including a two-part Phase 2/3 trial for resectable locally advanced Stage II-IV cutaneous squamous cell carcinoma (INTerpath-007), a Phase 2 trial for intermediate-high-risk, high-risk, or M1 no evidence of disease renal cell carcinoma (INTerpath-004), and a Phase 2 trial for high-risk muscle-invasive urothelial carcinoma post-radical resection (INTerpath-005).
In June, Merck and Moderna shared promising results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, highlighting the potential of V940 in combination with Keytruda as an adjuvant treatment for melanoma. With a median follow-up of approximately three years (34.9 months), the combination demonstrated a clinically significant and durable improvement in recurrence-free survival (RFS), reducing the risk of recurrence or death by 49% compared to Keytruda alone.
The positive results from these ongoing trials highlight the potential of V940 as a promising new treatment option for patients with various cancers. The initiation of INTerpath-009 marks a significant step forward in evaluating the efficacy of V940 in treating NSCLC patients who have not achieved complete remission after standard treatment regimens. The results of this trial are eagerly anticipated by the medical community, as they could potentially lead to improved treatment outcomes for a substantial patient population.
