Moderna reports first positive Phase 3 for mRNA neoantigen therapy in melanoma

Today marks an important milestone for @moderna_tx , for the field of mRNA, and for the many people working to bring new possibilities to patients. This morning, Moderna and Merck announced positive Phase 3 results for adjuvant treatment with intismeran autogene, an individualized mRNA therapy for melanoma, in combination with KEYTRUDA, in patients with completely resected stage IIB-IV melanoma. The study met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival. This is the first positive Phase 3 result for an individualized neoantigen therapy, and the first for an mRNA-based cancer therapy. When we founded Moderna in 2010, the idea that mRNA could become a new class of medicines was outright rejected. The idea that we might use it to create a therapy designed around the unique mutations in an individual patient’s tumor was even further from reality. Today’s result is a reminder of what can emerge from pioneering: asking questions others have not yet asked, following the science where it leads, and persevering through uncertainty. There is important work still ahead but today is a moment to recognize the extraordinary work behind this milestone. Congratulations to the entire Moderna team, our partners at Merck, and the investigators who made this study possible. Most importantly, my gratitude goes to the patients and families whose participation enables progress like this. Proud of this milestone, and of everyone who helped bring us here. Moderna and @Merck today announced positive topline results from the Phase 3 INTerpath-001 trial evaluating adjuvant treatment with intismeran autogene, a novel investigational mRNA-based individualized neoantigen therapy jointly developed by Merck and Moderna, in combination