Partners Moderna and Merck (MSD) have started a phase 3 trial assessing their mRNA cancer vaccine, V940, in combination with Keytruda, for adjuvant treatment in patients with non-small cell lung cancer (NSCLC).
The INTERPATH-002 trial has started recruiting, with the initial patients enrolled in Australia. The trial will include approximately 868 patients with completely resected stage II, IIIA, or IIIB NSCLC. Participants will undergo randomization for V940 and Keytruda combination treatment or Keytruda alone, following surgical resection and adjuvant chemotherapy, for up to one year or until disease recurrence.
In addition, the combination of V940 and Keytruda is under investigation in INTERPATH-001, a global phase 3 trial evaluating approximately 1,089 patients with resected high-risk melanoma. The clinical development program for V940 is expected to expand to cover additional tumor types.
V940 is an investigational mRNA-based individualized neoantigen therapy designed to train and activate an antitumor immune response based on the unique mutational signature of a patient's tumor. Merck's blockbuster Keytruda, an immunotherapy, enhances the immune system's ability to detect and fight tumor cells. The ongoing phase 2b KEYNOTE-942/mRNA-4157-P201 trial has previously suggested that combining V940 with Keytruda may offer a benefit over Keytruda alone.
The collaborative effort underscores a six-year partnership between Moderna and Merck, leveraging their combined expertise in mRNA and immuno-oncology. As Merck exercises its option to jointly develop and commercialize mRNA-4157/V940, both companies will continue to equally share costs and profits globally.
