Trilaciclib is being evaluated across a range of tumor types and chemotherapy regimens to assess its potential myeloprotection, antitumor efficacy and safety in combination with chemotherapy and other agents.
Small cell lung cancer (SCLC)
Enrollment is complete (326 participants) in PRESERVE 1, a pivotal Phase 3 trial of trilaciclib for patients with metastatic colorectal cancer. This trial is evaluating the myelopreservation and survival impact of trilaciclib, as well as potential safety and tolerability in combination with chemotherapy. More information on the trial, including enrollment criteria and clinical trial sites, is available here.
Colorectal cancer, also known as bowel cancer, colon cancer, or rectal cancer, is the third most common cancer in men and women, excluding certain skin cancers. Globally, it is the second leading cause of cancer death, with more than 1.8 million people newly diagnosed with colorectal cancer each year. In the United States, there are approximately 150,000 new cases of colorectal cancer diagnosed each year.
According to the World Health Organization, an estimated 2.3 million cases of breast cancer are diagnosed annually worldwide. Triple-negative breast cancer, or TNBC, makes up approximately 15-20% of such diagnosed breast cancers. Because TNBC cells lack key growth-signaling receptors, patients do not respond well to medications that block estrogen, progesterone, or HER2 receptors. TNBC is considered to be more aggressive and have a poorer prognosis than other types of breast cancer and is more likely than some other types of breast cancer to return after it has been treated.
We are currently enrolling patients in three clinical trials in patients living with TNBC.
PRESERVE 2 is a pivotal Phase 3, randomized, double-blind, placebo-controlled study of trilaciclib in patients receiving first-line gemcitabine and carboplatin chemotherapy for locally advanced unresectable or metastatic triple-negative breast cancer. PRESERVE 2 is evaluating the potential survival impact of trilaciclib in 170 patients with locally advanced unresectable or metastatic TNBC. More information on the trial, including enrollment criteria and clinical trial sites, is available here.
Patients are also being enrolled in two Phase 2 breast cancer trials: The first is evaluating trilaciclib in combinataion with an antibody-drug conjugate (ADC) in 2L/3L TNBC. The second is being conducted to confirm the mechanism of action of trilaciclib in neoadjuvant TNBC.
Bladder cancer is the most common malignancy involving the urinary system and is the sixth most common cancer in the United States. According to the American Cancer Society, there are over 81,000 new cases of bladder cancer diagnosed in the United States each year, and over 17,000 reported annual deaths. Globally, there are nearly 575,000 new bladder cancer diagnoses each year.
We are currently enrolling patients in PRESERVE 3, Phase 2, randomized, open-label study of trilaciclib administered with first-line platinum-based chemotherapy and the immune checkpoint inhibitor avelumab maintenance therapy in patients with untreated, locally advanced or metastatic urothelial carcinoma (mUC). Myeloprotection and anti-tumor efficacy endpoints are being assessed in this study. More information on the trial, including enrollment criteria and clinical trial sites, is available here.