G1 Therapeutics Advances Trilaciclib Phase 3 Trial for mTNBC Post Interim Review

G1 Therapeutics is a biopharmaceutical company with a clear mission to enhance the lives of cancer patients by developing innovative next-generation therapies. The company's first commercial product, COSELA® (trilaciclib), is a testament to their dedication to advancing cancer treatment. COSELA® is a transient CDK4/6 inhibitor administered intravenously, designed to protect bone marrow and immune system function during chemotherapy, thereby improving patient outcomes.

The company is currently conducting a pivotal Phase 3 trial, known as PRESERVE 2, which is evaluating the efficacy of trilaciclib in combination with gemcitabine and carboplatin for the first-line treatment of metastatic triple-negative breast cancer (mTNBC). This aggressive form of breast cancer, which lacks key growth-signaling receptors, does not respond well to medications that block estrogen, progesterone, or HER2 receptors. As a result, chemotherapy, radiation, and surgery are the typical treatment options. mTNBC is known for its lower survival rates and higher likelihood of recurrence, especially in the first few years after treatment.

The PRESERVE 2 trial is a global, multi-center, randomized, placebo-controlled study. Eligible patients are randomized to receive either trilaciclib or a placebo before the administration of gemcitabine and carboplatin. The treatment is given in 21-day cycles until disease progression. The final analysis of the trial, focusing on Overall Survival (OS), is expected to take place in the third quarter of 2024.

G1 Therapeutics is committed to providing innovative therapeutic advances for people living with cancer. They are also exploring the potential of their therapies in combination with cytotoxic therapies and/or immunotherapy for other high-unmet-need areas, such as extensive stage small cell lung cancer. The company's goal is to optimize chemotherapy and advance survival rates for cancer patients, and they are confident in the potential of trilaciclib to achieve the primary endpoint of the OS based on the robust survival benefit demonstrated in previous studies.

The company's focus on improving the lives of those affected by cancer is shared by its collaborative and diverse team. They are always on the lookout for new talent to join their mission, fostering a culture that values innovation and the pursuit of better cancer therapies.

In summary, G1 Therapeutics is at the forefront of developing next-generation cancer therapies, with a particular emphasis on improving the outcomes for patients with mTNBC. Their ongoing clinical trials and commitment to scientific innovation are driving the company towards a future where cancer treatment is more effective and less debilitating for patients.