An open-label, phase 1b study of NEO-PV-01 with pembrolizumab plus chemotherapy in patients with advanced or metastatic nonsquamous non-small cell lung cancer.

TPS3134Background: Cancer cells contain unique DNA mutations that result in altered amino acid sequences known as neoantigens. Evidence supports a central role for neoantigens as targets for tumor-directed immune responses. Tumor mutational burden as well as neoantigen load are associated with anti-tumor activity of checkpoint inhibitors. Chemotherapy plus anti-PD1 therapy in NSCLC has demonstrated improved efficacy over chemotherapy alone. This combination reduces early progression and may also modulate the tumor microenvironment. Neoantigen vaccines offer a rational combination partner for these therapies as a highly specific way to induce de novo T cell reactivity and to expand existing T cell responses against neoantigens. Here, we describe a clinical trial combining NEO-PV-01, a personal neoantigen vaccine designed specifically for the molecular profile of each individual’s tumor, with anti-PD1 and chemotherapy. Methods: NT-002 is a single-arm, phase 1B study evaluating the safety of administering NE...