G1 Therapeutics Announces Clinical Benefits of "Global New" Trilaciclib Spinal System March 06, 2018 Source: Sina Pharmaceutical On March 5th, G1 Therapeutics, a biotechnology company focused on cancer treatment, published the top-line data of the active phase 2a trial of its drug trilaciclib for patients with small cell lung cancer treated with first-line chemotherapy. Trilaciclib is the world's first short-acting CDK4/6 inhibitor for the protection of hematopoietic stem cells and immune system function (myeloid benefit) during chemotherapy. Dr. Raj Malik, Chief Medical Officer and Senior Vice President of the company, said: "The data from this trial show clear evidence that trilaciclib effectively protects the bone marrow and immune system from chemotherapy. In addition, the myeloid protection shown by trilaciclib The effect improves the patient's prognosis. Chemotherapy remains the cornerstone of cancer treatment, and trilaciclib has the potential to benefit many of these patients." The clinical study was a placebo-controlled, double-blind trial in which patients were enrolled in patients with extensive small cell lung cancer. Seventy-seven newly diagnosed patients were randomized according to 1:1, and 75 received an intravenous infusion of trilaciclib or placebo prior to standard doses of etoposide and carboplatin (EP) chemotherapy. Participants in the experimental arms were able to receive standard supportive care as recommended by the clinical investigator. Growth factors [including granulocyte colony-stimulating factor (G-CSF) and erythropoietin] and blood transfusion support were available to all participants. Several clinically relevant hematologic endpoints were prospectively defined in the statistical analysis protocol. Data from the 2a trial of the effectiveness signal generation phase showed that trilaciclib can reduce the clinically relevant results of chemotherapy-induced myelosuppression compared with placebo. Trilaciclib is well tolerated and there are no 3/4 grade trilaciclib treatment-related emergency adverse events (TEAES) reports. Baseline patients and disease characteristics were well balanced between the two arms. The main hematological results are shown in the table below: In contrast to the placebo group, trilaciclib also showed a good trend to reduce grade 3 anemia, red blood cell transfusion, and grade 3 platelet fever, with no grade 4 anemia or thrombocytopenia in either group. In addition to showing bone marrow benefit, Triaciclib showed a good trend in total response rate (ORR), duration of response (DOR), and progression-free survival (PFS) compared with placebo. Lifetime data is not yet mature: The ORR assessed by the Independent Evaluation Committee (BICR) was 66.7% for trilaciclib and 62.2% for placebo (p=0.6759); Median DOR (BICR): 3.7 months for trilaciclib and 4.3 months for placebo (p=0.1449); The median PFS (investigator, including clinical progress) was 6.2 months for trilaciclib and 5.0 months for placebo (HR 0.6, p=0.06). The company plans to share this data with US and European regulators this year and discuss the next steps to develop trilaciclib. The company also plans to publish test results including the latest data from Phase 1b at a medical conference later this year. G1 is currently conducting two additional trials of trilaciclib to assess its myelocyte protection against second- and third-line SCLC and first-line/second-line/triple-negative triple-negative breast cancer, and preliminary trials for both trials are expected in the fourth quarter of 2018. data. In addition to bone marrow protection, the effect of triaciclib on overall survival (OS) was also assessed as part of a joint regimen with tecentriq/carboplatin/etoposide in a phase 2, extensive phase SCLC phase 2 trial. The recruitment of the trial was completed last month, two quarters ahead of schedule. Dr. Mark Velleca, CEO of G1, said: “This positive data provides us with a solid foundation to drive the continued development of trilaciclib and its ultimate commercialization. As shown by the non-exclusive collaboration with Genentech, Trilaciclib combined with checkpoint inhibitor/chemotherapy has great potential. It is believed that trilaciclib has the potential to become the backbone of multiple cancer-type chemotherapy regimens, bringing huge benefits to patients and creating a large amount of long-term commercial value." (Sina Pharmaceutical Compilation / David) Article Reference Source: G1 Therapeutics Announces Positive Trilaciclib Phase 2a Topline Data Showing Robust Myelopreservation Benefits in Patients with Small Cell Lung Cancer GMP Certificated Immune Globulin Injection Supplier in China Hepatitis B Immunoglobulin,Hep B Immunoglobulin,Hepatitis B Immunoglobulin Vaccine,Hepatitis Immune Globulin FOSHAN PHARMA CO., LTD. , https://www.fospharma.com
