INTerpath-002, a phase III study evaluating V 940 (mRNA-4157) + Keytruda (pembrolizumab) for adjuvant treatment of patients with certain types of resected non-small cell lung cancer- Merck Inc., + Moderna Inc.
Merck Inc., known as MSD outside of the United States and Canada, and Moderna, Inc. announced the initiation of INTerpath-002, a pivotal Phase III randomized clinical trial evaluating V 940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with Keytruda, Merck’s anti-PD-1 therapy, as adjuvant treatment in patients with completely resected (R0) Stage II, IIIA or IIIB (with nodal involvement [N2]) non-small cell lung cancer (NSCLC).
Global recruitment of the INTerpath-002 has begun, and the first patients enrolled in Australia.
“As lung cancer is the leading cause of cancer death worldwide, there is a need for continued scientific advancements to help fight this disease at earlier stages when patients have the best chance for better outcomes,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “By combining Keytruda with V 940 (mRNA-4157), a promising new modality, we are researching innovative new approaches for earlier stage non-small cell lung cancer.”
As previously announced, in addition to INTerpath-002, the combination of V 940 (mRNA-4157) plus Keytruda is being investigated in INTerpath-001, formerly referred to as V940-001 (NCT05933577), a global, randomized, double-blind, placebo- and active-comparator-controlled Phase III trial evaluating approximately 1,089 patients with resected high-risk (Stage IIB-IV) melanoma. INTerpath-001 is actively screening in 14 countries (Australia, Belgium, Canada, Chile, France, Germany, Greece, Israel, Italy, Poland, Portugal, Spain, Turkey and the United Kingdom), representing 38 sites. The companies plan to continue expansion of the comprehensive clinical development program for V 940 (mRNA-4157) to additional tumor types.
About INTerpath-002 (NCT06077760): INTerpath-002 is a global, randomized, double-blind, placebo- and active-comparator-controlled Phase III trial evaluating approximately 868 patients with completely resected Stage II, IIIA or IIIB [N2] NSCLC. Following complete surgical resection and adjuvant chemotherapy, participants 18 years and older will be randomized 1:1 to receive V 940 (mRNA-4157) (1 mg every three weeks for up to nine doses) and Keytruda (400 mg every six weeks for up to nine cycles) versus Keytruda alone for approximately one year or until disease recurrence or any of the other criteria for discontinuation of study intervention are met. The primary endpoint is disease-free survival (DFS), defined as the time from randomization to any recurrence or occurrence of new primary NSCLC as assessed by the investigator, or death due to any cause. The secondary endpoints are overall survival (OS), distant metastasis-free survival (DMFS), lung cancer specific survival (LCSS), safety, and quality of life.
Key eligibility criteria for the trial include: completion of surgical resection of histologically confirmed Stage II, IIIA or IIIB (N2) squamous or nonsquamous NSCLC, confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy, no evidence of disease at the time of providing documented consent for the main study, prior treatment with at least one dose of adjuvant therapy with standard-of-care platinum-based doublet chemotherapy up to four cycles, and no more than 24 weeks between surgical resection with curative intent and the first dose of Keytruda.
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