G1 Therapeutics to Continue Pivotal Phase 3 Trial of Trilaciclib in Metastatic Triple Negative Breast Cancer Following Interim Analysis by Independent Data Monitoring Committee
RESEARCH TRIANGLE PARK, N.C., Feb. 12, 2024 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the independent Data Monitoring Committee (DMC) recommended continuation of the pivotal Phase 3 trial (PRESERVE 2), evaluating trilaciclib in combination with gemcitabine and carboplatin for the first line treatment of metastatic triple negative breast cancer (mTNBC), to the final analysis. This final analysis evaluating Overall Survival (OS) is estimated to occur in the third quarter of 2024 and will be conducted on the intent-to-treat (ITT) population. The DMC did not express any concerns regarding safety or recommend any other changes to the study. G1 remains blinded to all data as the early stopping criteria were not met during the interim analysis.