NEW YORK – Moderna and Merck will test their personalized neoantigen cancer vaccine V940 with Merck's checkpoint inhibitor Keytruda (pembrolizumab) in certain non-small cell lung cancer patients in a Phase III pivotal trial, the research partners said Monday.
In INTerpath-009, Merck and Moderna will randomize patients to receive either V940, also called mRNA-4157, with Keytruda or Keytruda plus a placebo in the adjuvant setting. To be eligible for the trial, patients must have stage II, IIIA, or IIIB NSCLC and have not achieved pathological complete response after neoadjuvant Keytruda plus chemotherapy and surgical resection. The drugmakers hope to enroll 680 patients globally in this trial and have already begun enrolling patients at sites in Canada.
The drugmakers are evaluating patients' disease-free survival outcomes as the primary endpoint in the trial. They are also measuring overall survival and distant metastasis-free survival, among other secondary outcomes.
Merck and Moderna are codeveloping the personalized neoantigen vaccine, which involves harvesting patients' tumors, then analyzing their samples alongside normal tissue to identify up to 34 neoantigens unique to each patient's cancer. Then, Merck and Moderna encode these specific neoantigens into an mRNA strand, which they pack into an injectable lipid nanoparticle and administer to patients intramuscularly.
The treatment has already demonstrated promise in patients with high-risk melanoma, and Merck and Moderna are also studying the vaccine in certain kidney cancer and bladder cancer patients.
The firms are also evaluating V940 as an adjuvant treatment for NSCLC patients who haven't received neoadjuvant therapy in the Phase III INTerpath-002 trial.
"Together, INTerpath-002 and INTerpath-009 are designed to demonstrate this potential in early-stage lung cancer, with and without prior neoadjuvant therapy," Kyle Holen, senior VP and head of therapeutics and oncology development at Moderna, said in a statement.