Trilaciclib is a first-in-class myelopreservation therapy designed to improve outcomes of patients who receive chemotherapy by preserving hematopoietic stem and progenitor cell (HSPC) and immune system function. Trilaciclib is a short-acting intravenous CDK4/6 inhibitor administered prior to chemotherapy.
Trilaciclib is being evaluated in four randomized Phase 2 clinical trials; G1 has reported positive results from all of these trials in 2018. Two trials showed myelopreservation benefits in treatment-naive SCLC patients. In one of the first-line SCLC trials, trilaciclib was administered in combination with a chemotherapy regimen of etoposide and carboplatin (NCT02499770); topline data were released in March and additional data were reported at the European Society of Medical Oncology 2018 Congress. In another first-line SCLC trial, trilaciclib was administered in combination with the same chemotherapy regimen and the checkpoint inhibitor Tecentriq® (atezolizumab) (NCT03041311); topline data were reported in November. Preliminary results from a trial in combination with chemotherapy in metastatic triple-negative breast cancer (NCT02978716) showing improved progression-free survival and multi-lineage myelopreservation benefits were presented at the San Antonio Breast Cancer Symposium on December 5, 2018. The company issued a press release on positive topline data from a trial in combination with chemotherapy in previously treated SCLC (NCT02514447) on December 19, 2018.
Data from a Phase 1 trial in healthy volunteers were published in Science Translational Medicine. Trilacicilib has been extensively studied in animals; these preclinical data have been presented at multiple scientific meetings and published in Molecular Cancer Therapeutics, Science Translational Medicine and Cancer Discovery.