G1 Therapeutics presents data from Phase 2 trial of Trilaciclib, chemo combo
G1 Therapeutics reported preliminary overall survival data from the company's randomized Phase 2 trial of trilaciclib in combination with chemotherapy for the treatment of metastatic triple-negative breast cancer. In the trial, median overall survival for patients treated with trilaciclib in combination with a chemotherapy regimen of gemcitabine/carboplatin was 20.1 months, compared with 12.6 months for patients receiving chemotherapy alone. The randomized, open-label Phase 2 study of trilaciclib in combination with GC, a current standard of care for TNBC, enrolled 102 patients who had received up to two prior chemotherapy regimens for locally recurrent or metastatic TNBC. In this three-arm trial, all three groups received a chemotherapy regimen of GC. Patients were randomized to receive GC only or GC plus one of two dosing schedules of trilaciclib: trilaciclib administered on the day of chemotherapy or trilaciclib administered the day prior to and the day of chemotherapy. Primary endpoints for the trial included myelopreservation measures; secondary endpoints included additional myelopreservation measures and anti-tumor efficacy measures of overall response rate, progression-free survival and OS. Updated results from the trial showed that the addition of trilaciclib to chemotherapy resulted in a significant increase in OS in both treatment groups compared to chemotherapy alone. Compared to GC alone, OS was improved for both trilaciclib arms with median OS of 12.6 months, 20.1 months and 17.8 months, respectively. The median OS for Groups 2 and 3 combined was 20.1 months. The median OS for GC alone was consistent with historical data. PFS and ORR were consistent with previously reported data. The safety and tolerability of trilaciclib were consistent with previously reported data. There have been no serious adverse events attributed to treatment with trilaciclib in this trial. Patient-reported outcome measures related to anemia were improved in patients receiving trilaciclib versus patients receiving chemotherapy alone. As previously reported, primary endpoints were not met.