Trial in progress: A phase 3, randomized, double-blind trial of trilaciclib versus placebo in patients receiving first- or second-line gemcitabine and carboplatin for locally advanced unresectable or metastatic triple-negative breast cancer (PRESERVE 2).

Abstract

TPS1107 Background: Trilaciclib is an intravenous (IV), highly potent and selective, reversible cyclin-dependent kinase (CDK) 4/6 inhibitor that protects hematopoietic stem and progenitor cells during chemotherapy (myeloprotection) and may directly enhance antitumor immunity (anticancer efficacy). In a randomized phase 2 trial of trilaciclib administered prior to gemcitabine and carboplatin (GC) versus GC alone in advanced/metastatic triple-negative breast cancer (mTNBC), although the primary endpoint of myeloprotection was not met, the addition of trilaciclib resulted in a substantial improvement in median overall survival (OS; 19.8 months with trilaciclib vs 12.6 months with placebo, haza..