Merck and Moderna Initiate Phase III INTerpath-002 Trial of Personalized mRNA Cancer Vaccine V940 (mRNA-4157) Combined with Pembrolizumab in Resected Non-Small Cell Lung Cancer

On December 11, MSD and Moderna jointly announced the launch of the Phase III INTerpath-002 study to evaluate the efficacy and safety of the personalized neoantigen therapy, tumor mRNA vaccine V940 (mRNA-4157), in combination with pembrolizumab as adjuvant treatment for patients with completely resected (R0) stage II, IIIA, or IIIB (lymph node involvement [N2]) non-small cell lung cancer (NSCLC). Global recruitment for INTerpath-002 has now begun, with the first group of patients receiving treatment in Australia. The two companies plan to further expand the comprehensive clinical development program for V940 to other tumor types.

INTerpath-002 is a global, randomized, double-blind, placebo-controlled and active-controlled Phase III trial, planning to enroll approximately 868 patients with NSCLC. After complete surgical resection and adjuvant chemotherapy, patients will be randomized 1:1 to receive either V940 (1 mg every 3 weeks for up to 9 doses) in combination with pembrolizumab (400 mg every 6 weeks for up to 9 cycles) vs. pembrolizumab monotherapy for approximately one year or until disease recurrence or meeting any other criteria for discontinuation of study intervention. The primary endpoint is disease-free survival (DFS).

"Lung cancer is the leading cause of cancer death worldwide, so continuous scientific progress is needed to help patients fight this disease at an early stage when they are most likely to achieve better treatment outcomes," said Dr. Marjorie Green, Senior Vice President of Merck & Co., Inc. Research Laboratories and Head of Global Clinical Development for Late-Stage Oncology: "By combining pembrolizumab with V940, a promising new therapeutic modality, we are exploring innovative new approaches to treating early-stage non-small cell lung cancer."

In addition to INTerpath-002, the INTerpath-001 (NCT05933577) study of V940 in combination with pembrolizumab for high-risk (IIB-IV stage) melanoma is also underway.

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