![]() ![]() Safety, tolerability and recommended phase 2 dose (RP2D) of an individualized, heterologous chimpanzee adenovirus (ChAd68) and self-amplifying mRNA (samRNA)-based neoantigen vaccine in combination with nivolumab and ipilimumab were assessed as primary endpoints in an ongoing phase 1/2 study in patients with advanced metastatic solid tumors (NCT03639714). T cell-inducing vaccines hold promise to exert long-lasting disease control in combination with CPI therapy. Although small study size limits statistical and translational analyses, the increased OS observed in MSS-CRC warrants further exploration in larger randomized studies.Ībstract = "Checkpoint inhibitor (CPI) therapies provide limited benefit to patients with tumors of low immune reactivity. Exploratory biomarker analyses showed decreased circulating tumor DNA (ctDNA) in patients with prolonged OS. Several patients with microsatellite-stable colorectal cancer (MSS-CRC) had improved OS. Vaccine manufacturing was feasible, with vaccination inducing long-lasting neoantigen-specific CD8 T cell responses. Secondary endpoints included immunogenicity, feasibility of manufacturing and overall survival (OS). The RP2D was 10 12 viral particles (VP) ChAd68 and 30 µg samRNA. Serious TRAEs included one count each of pyrexia, duodenitis, increased transaminases and hyperthyroidism. Treatment-related adverse events (TRAEs) >10% included pyrexia, fatigue, musculoskeletal and injection site pain and diarrhea. The individualized vaccine regimen was safe and well tolerated, with no dose-limiting toxicities. ![]() Checkpoint inhibitor (CPI) therapies provide limited benefit to patients with tumors of low immune reactivity. ![]()
0 Comments
Leave a Reply. |
Details
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |