G1 Therapeutics’ Phase 3 trial of trilaciclib for metastatic triple negative breast cancer continues as planned


In a significant update for the oncology community, G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage company specializing in cancer treatment, announced the continuation of its pivotal Phase 3 trial (PRESERVE 2). This trial is evaluating trilaciclib, in combination with gemcitabine and carboplatin, as a first-line treatment for metastatic triple negative breast cancer (mTNBC), a particularly aggressive form of the disease. The independent Data Monitoring Committee (DMC) has recommended proceeding to the final analysis without any modifications, underscoring the trial’s integrity and the absence of safety concerns. The much-anticipated final analysis on Overall Survival (OS) is expected in the third quarter of 2024.

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Jack Bailey, CEO of G1 Therapeutics, expressed confidence in trilaciclib’s potential, citing robust survival benefits observed in previous studies and the increased statistical power of the current Phase 3 trial. Despite the trial not meeting early stopping criteria at the interim analysis, Bailey’s outlook remains optimistic about introducing this first-in-class therapy to patients facing this highly aggressive cancer variant.

Trilaciclib stands out as a novel therapeutic approach. As an intravenous (IV) transient CDK4/6 inhibitor, it’s designed to protect bone marrow and immune system function during cytotoxic therapy, potentially improving outcomes for patients undergoing treatment. The global, multi-center, randomized placebo-controlled PRESERVE 2 trial is pivotal in determining trilaciclib’s efficacy and safety for patients with locally advanced unresectable or metastatic TNBC, offering hope for a new treatment option in a field where advancements are critically needed.

Independent DMC Recommends No Changes to G1 Therapeutics' PRESERVE 2 Trial Evaluating Trilaciclib

Independent DMC Recommends No Changes to G1 Therapeutics’ PRESERVE 2 Trial Evaluating Trilaciclib

Breast cancer remains the most diagnosed cancer worldwide, with triple negative breast cancer accounting for 15-20% of these cases. TNBC is characterized by the absence of estrogen receptors, progesterone receptors, and excess HER2 protein, making traditional hormone-based therapies ineffective. This has historically necessitated a reliance on chemotherapy, radiation, and surgery, with TNBC patients facing poorer prognoses and higher recurrence rates compared to other breast cancer subtypes.

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The continuation of the PRESERVE 2 trial represents a beacon of hope for patients and healthcare providers alike, signaling potential advancements in the treatment of mTNBC. As G1 Therapeutics nears the final analysis of this study, the oncology community eagerly awaits results that could redefine the standard of care for one of the most challenging forms of breast cancer.

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