Initiation of INTerpath-009, a pivotal Phase III randomized clinical trial evaluating V940 (mRNA-4157) in combination with Keytruda (pembrolizumab),- Merck inc. + Moderna
Merck Inc.,, (known as MSD outside of the United States and Canada), and Moderna, Inc. announced the initiation of INTerpath-009, a pivotal Phase III randomized clinical trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as adjuvant treatment for patients with resectable Stage II, IIIA or IIIB (N2) non-small cell lung cancer (NSCLC) 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 now started enrolling in Canada.
“While the overall survival rates for patients with non-small cell lung cancer have significantly improved in recent years, lung cancer continues to be the leading cause of cancer death worldwide,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “We are pleased to expand the INTerpath clinical trial program with Moderna, evaluating V940 (mRNA-4157), a promising new modality, in combination with Keytruda to pursue meaningful advances for lung cancer and bring more options to patients with earlier stages of disease, where we potentially can have the most impact.”
Ongoing clinical development programs; Merck and Moderna have initiated Phase III randomized clinical 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, NCT05933577 ) and non-small cell lung cancer (INTerpath-002, NCT06077760 ).
In 2024, Merck and Moderna also initiated a two-part Phase II/III randomized clinical trial evaluating mRNA-4157 (V940) in combination with Keytruda as neoadjuvant and adjuvant treatment in patients with resectable locally advanced Stage II-IV (M0) cutaneous squamous cell carcinoma (INTerpath-007, NCT06295809 ), a Phase II randomized clinical trial evaluating mRNA-4157 (V940) in combination with Keytruda as adjuvant treatment in patients with intermediate-high-risk, high-risk, or M1 no evidence of disease renal cell carcinoma (INTerpath-004, NCT06307431 ), and a Phase II randomized clinical trial evaluating mRNA-4157 (V940) in combination with Keytruda as adjuvant treatment in patients with high-risk muscle-invasive urothelial carcinoma post-radical resection (INTerpath-005, NCT06305767 ).
About INTerpath-009 ( NCT06623422 ); INTerpath-009 is a global, randomized, double-blind Phase III trial evaluating 680 patients with resected (R0 or R1) Stage II, IIIA, IIIB (N2) NSCLC who did not achieve a pCR after neoadjuvant Keytruda plus platinum-based chemotherapy. Following surgical resection, participants 18 years and older will be randomized 1:1 to receive either V940 (mRNA-4157) (1 mg every three weeks for up to nine doses) and Keytruda (400 mg every six weeks up to seven cycles) or placebo (1 mg every three weeks for up to nine doses) and Keytruda (400 mg every six weeks up to seven cycles). The primary endpoint is disease-free survival (DFS), defined as the time from randomization to any recurrence (local, locoregional, regional, or distant), occurrence of new primary NSCLC, as assessed by the investigator, or death due to any cause, whichever occurs first. The secondary endpoints are overall survival (OS), distant metastasis-free survival (DMFS), DFS2, lung cancer-specific survival (LCSS), safety, and quality of life.
Key eligibility criteria for the trial include: patients who have histologically/cytologically confirmed diagnosis of Stage II, IIIA, or IIIB (N2) NSCLC (American Joint Committee on Cancer [AJCC] 8th Edition), have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, no pCR by local testing after neoadjuvant chemotherapy plus Keytruda, completed surgery, with no disease by baseline imaging , and exclude epidermal growth factor receptor (EGFR) mutation.
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