G1 Therapeutics, Inc. (NASDAQ:GTHX), a commercial-stage oncology company, today announced that the Company has initiated PRESERVE 4, a multicenter randomized, double blind, placebo controlled Phase 2 study of COSELA™ (trilaciclib) administered prior to docetaxel in patients with metastatic non-small cell lung cancer (NSCLC) in the 2nd and 3rd line setting who have previously been treated with a checkpoint inhibitor and chemotherapy. Anti-tumor efficacy and myeloprotection endpoints are being assessed in this study. Results of this study are expected in the first half of 2023.
"Non-small cell lung cancer is the most common type of lung cancer, accounting for nearly 85% of all diagnoses, and remains a great unmet medical need," said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics. "Despite improvements in therapy for metastatic NSCLC, including the use of PD-1 or PD-L1 inhibitors, the majority of patients ultimately progress during or after treatment with immunotherapy and chemotherapy. In addition to the need for therapies that more effectively extend overall survival, patients treated in the metastatic setting are particularly vulnerable to chemotherapy-induced myelosuppression and health-related quality of life impacts associated with systemic chemotherapy. We are exploring both potential benefits of COSELA in PRESERVE 4."