RESEARCH TRIANGLE PARK – G1 Therapeutics, Inc. (NASDAQ:), an oncology-focused biopharmaceutical company, announced today that its Phase 3 clinical trial, PRESERVE 2, will proceed to final analysis as recommended by the independent Data Monitoring Committee (DMC). The trial is assessing the efficacy of trilaciclib in combination with chemotherapy for the treatment of metastatic triple-negative breast cancer (mTNBC).
The DMC, after reviewing interim data, advised continuation without modifications, citing no safety concerns. The final analysis, expected in the third quarter of 2024, will evaluate Overall Survival (OS) in the intent-to-treat population.
Trilaciclib is an intravenously administered CDK4/6 inhibitor, a novel therapeutic approach designed to protect bone marrow and immune system function during chemotherapy, potentially enhancing patient outcomes. The PRESERVE 2 trial is a global, multi-center, randomized, placebo-controlled study that enrolls patients with locally advanced unresectable or metastatic TNBC. Participants are randomized to receive either trilaciclib or a placebo prior to the first-line chemotherapy regimen of gemcitabine and carboplatin, administered on a 21-day cycle until disease progression.
Triple-negative breast cancer is a particularly aggressive form of the disease, accounting for 15-20% of breast cancer diagnoses in the United States. It is characterized by the absence of estrogen and progesterone receptors and excess HER2 protein, which makes it unresponsive to hormonal or HER2-targeted therapies. Instead, TNBC is typically managed with chemotherapy, radiation, and surgery.
Jack Bailey, CEO of G1 Therapeutics, expressed confidence in the potential of trilaciclib to meet the primary endpoint of OS, drawing from the survival benefit observed in a previous Phase 2 study. Bailey indicated that while a positive interim analysis could have expedited the availability of trilaciclib, the company looks forward to potentially offering this treatment to patients as early as next year.
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