Trilaciclib is being evaluated across a range of tumor types and chemotherapy regimens to assess its potential myeloprotection and antitumor efficacy and safety in combination with chemotherapy and other agents.
Small cell lung cancer (SCLC)
We are currently enrolling participants in a 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 the U.S. and the second cause of cancer-related deaths. The American Cancer Society expects to see over 104,000 new cases of colon cancer and over 45,000 new cases of rectal cancer in the United States.
According to the American Cancer Society, nearly 300,000 new cases of invasive breast cancer are diagnosed annually in the U.S. Triple-negative breast cancer 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 PRESERVE 2, a pivotal Phase 3, randomized, double-blind, placebo-controlled study of trilaciclib in patients receiving first- or second-line gemcitabine and carboplatin chemotherapy for locally advanced unresectable or metastatic triple-negative breast cancer. PRESERVE 2 will evaluate the potential survival impact of trilaciclib in 250 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 a neoadjuvant breast cancer trial in collaboration with the Quantum Leap Healthcare Collaborative™ (QLHC) as part of the I-SPY 2 clinical trial platform.
Bladder cancer is the most common malignancy involving the urinary system and is the sixth most common cancer in the United States. The American Cancer Society estimates that approximately 84,000 new cases of bladder cancer will be diagnosed in the U.S. in 2021.
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.
Non-small cell lung cancer
This year, an estimated 236,000 adults in the United States will be diagnosed with lung cancer; the American Cancer Society estimates that in 2020, there will be approximately 135,000 lung cancer deaths in the US alone. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 84% of all lung cancer diagnoses.
We are currently enrolling patients in PRESERVE 4, a multicenter randomized, double blind, placebo-controlled Phase 2 study of trilaciclib in post-checkpoint patients with metastatic NSCLC treated with docetaxel in the 2nd and 3rd line setting. 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.