G1' trilaciclib + chemo improved overall survival in breast cancer

 

• G1 Therapeutics (NASDAQ:GTHX) perks 9% after-hours after reporting final data from its Phase 2 trial of trilaciclib in metastatic triple-negative breast cancer (mTNBC)
• The Phase 2 trial enrolled 102 patients, to receive chemotherapy regimen of gemcitabine/carboplatin (GC) only (Group 1) or GC plus trilaciclib administered on the day of chemotherapy (Group 2) or trilaciclib administered the day prior to and the day of chemotherapy (Group 3). Key findings include:
• Compared to GC alone (Group 1), OS was improved in both trilaciclib arms (Groups 2 and 3) (Group 2: HR=0.31, p=0.0016; Group 3: HR=0.40, p=0.0004).
• Median OS was 12.6 months in Group 1, not reached for Group 2, and 17.8 months in Group 3. The median OS for Groups 2 and 3 combined was 19.8 months (HR=0.37, p<0.0001).
• OS and median OS findings in patients receiving trilaciclib were consistent with previously-reported data.
• The company plans to initiate a pivotal trial of trilaciclib in mTNBC in early 2021.
• In a subset analysis based on PD-L1 status, patients treated with trilaciclib and GC demonstrated improvement in OS compared to GC alone, with the PD-L1-positive subset achieving statistically significant improvement.
• In the analysis based on CDK4/6 status, trilaciclib did not impair the efficacy of GC and OS was similar, regardless of CDK4/6 status.
• Data from T-cell clonality analysis suggest that administering trilaciclib prior to chemotherapy enhanced immune system function.
• These data were presented at the 2020 San Antonio Breast Cancer Symposium.
• The company also presented updated monotherapy data from the Phase 1 portion of its ongoing clinical trial of rintodestrant for the treatment of ER+, HER2- breast cancer.
• Key clinical findings from the 67-patient trial included: Safety and tolerability findings across all doses, including the 600 mg and 1,000 mg expansion cohorts, were consistent with previously reported data.
• In a heavily pre-treated patient population, rintodestrant showed evidence of clinical activity, including 5% (3/67) of patients with confirmed partial responses, 36% (24/67) with stable disease, and a clinical benefit rate of 30% (20/67).
• https://seekingalpha.com/news/3643163-g1-therapeutics-trilaciclib-chemotherapy-improved-overall-survival-in-breast-cancer