G1T48 is a potential best-in-class oral selective estrogen receptor degrader (SERD). Preclinical data presented at the American Association for Cancer Research 2017 Annual Meeting demonstrated G1T48 to be more potent than Faslodex® (fulvestrant) and to have superior anti-tumor efficacy versus other SERDs in development. The company initiated a Phase 1/2a trial of G1T48 in estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer in 2018, and expects to present preliminary proof-of-concept data in 3Q19.
With its differentiated chemistry and high potency, we believe that G1T48 could be best-in-class and benefit ER+ breast cancer patients. There is strong scientific rationale and clinical validation supporting the combination of a CDK4/6 inhibitor and a SERD for the treatment of patients with ER+, HER2- breast cancer. Pending results from the Phase 1/2a trial, G1 is planning to initiate randomized trials of G1T48 as both monotherapy and in combination with oral CDK4/6 inhibitors.