Trilaciclib is a first-in-class FDA-designated "Breakthrough Therapy" designed to improve outcomes for people with cancer who are treated with chemotherapy. Positive data have been reported from four randomized trials – three in small cell lung cancer (SCLC) and one in metastatic triple-negative breast cancer (mTNBC). We have begun a rolling New Drug Application (NDA) submission in the U.S. for small cell lung cancer, which we expect to complete in the second quarter of 2020. We also plan to file a European regulatory submission and begin additional trials in colorectal cancer and breast cancer in 2020.
Small cell lung cancer (SCLC)
Chemotherapy is an effective and important weapon against cancer. However, chemotherapy does not differentiate between healthy cells and cancer cells and kills both, including important stem cells in the bone marrow that produce white blood cells, red blood cells and platelets. This chemotherapy-induced bone marrow damage is known as myelosuppression. When white blood cells, red blood cells and platelets become depleted, patients receiving chemotherapy are at an increased risk of infection, experience anemia and fatigue, and are at increased risk of bleeding. Myelosuppression often requires the administration of rescue interventions such as growth factors and blood or platelet transfusions, and may also result in chemotherapy dose delays and reductions. It can also mean more hospital and doctor visits – stressing both the patient and the healthcare system.
Myelopreservation refers to preserving bone marrow function. This can reduce chemotherapy-related toxicity, making chemotherapy safer and more tolerable, and also reduce the need for rescue interventions that address the effects of myelosuppression, such as growth factors or blood and platelet transfusions.
Based on positive findings in three Phase 2 clinical trials in SCLC and feedback from U.S. and European regulatory authorities, G1 plans to submit marketing applications in the U.S. and Europe for myelopreservation in patients with SCLC in 2020. Trilaciclib has been granted Breakthrough Therapy Designation (BTD) based on myelopreservation data in patients with SCLC from the U.S. Food and Drug Administration (FDA), and we plan to submit a New Drug Application (NDA) in the second quarter of 2020. The BTD program is designed to expedite development and review of drugs intended for serious or life-threatening conditions.
In June 2019, we announced preliminary overall survival (OS) data from a randomized Phase 2 trial, which demonstrated that women with metastic triple-negative breast cancer (mTNBC) lived significantly longer when receiving trilaciclib and chemotherapy compared with women receiving chemotherapy alone. These data were featured in an oral presentation session at the European Society for Medical Oncology (ESMO) Congress 2019 in September 2019 and were published in Lancet Oncology. In collaboration with the Quantum Leap Healthcare CollaborativeTM (QLHC), we are initiating a neoadjuvant breast cancer trial in 2Q20.