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G1 Therapeutics to Present Preliminary Data from Randomized Phase 2 Trial of Trilaciclib in Metastatic Triple-Negative Breast Cancer at 2018 San Antonio Breast Cancer Symposium (SABCS)
"Metastatic triple-negative breast cancer is difficult to treat. Chemotherapy is the standard of care, but there are efficacy and tolerability limitations with this therapeutic approach,” said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. “We look forward to presenting the findings of this randomized clinical trial in mTNBC as we continue to explore the potential anti-tumor efficacy and myelopreservation benefits of trilaciclib across a range of indications, chemotherapy regimens and lines of therapy.”
This randomized, open-label, Phase 2 clinical trial enrolled 102 patients with mTNBC who had received 0-2 prior lines of therapy. In this three-arm trial, all patients received a chemotherapy regimen of gemcitabine and carboplatin and were randomized to receive chemotherapy only or chemotherapy plus one of two dosing schedules of trilaciclib. Details on the presentation are listed below. The poster will be available on the Publications page of the company’s website following its presentation at SABCS.
Title: Trilaciclib (T), a CDK4/6 inhibitor, dosed with gemcitabine (G), carboplatin (C) in metastatic triple negative breast cancer (mTNBC) patients: Preliminary phase 2 results
Abstract Number: 1191
Presentation Number: PD1-01
Session Title: Developmental Therapeutics
Date / Time / Location: December 5, 5-7 p.m. CST/6-8 p.m. EST, Stars at Night Ballroom 1&2, Henry B. Gonzalez Convention Center
Presenter: Joyce O’Shaughnessy, M.D. (Texas Oncology-Baylor Charles A. Sammons Cancer Center)
For more information about the 2018 San Antonio Breast Cancer Symposium, please visit https://www.sabcs.org.
Trilaciclib is a first-in-class myelopreservation therapy designed to preserve hematopoietic stem and progenitor cell function and immune system function during chemotherapy. Trilaciclib is a short-acting intravenous CDK4/6 inhibitor administered prior to chemotherapy and has the potential to significantly improve treatment outcomes.
Trilaciclib is being evaluated in four randomized Phase 2 clinical trials. In March 2018, G1 announced positive Phase 2 data showing myelopreservation benefits in newly diagnosed, treatment-naive small cell lung cancer (SCLC) patients (NCT02499770). Additional results from this trial were reported at the European Society for Medical Oncology (ESMO) 2018 Congress. The company plans to report data from three other randomized Phase 2 trials in 2018: a trial in combination with chemotherapy and Tecentriq® in first-line SCLC (NCT03041311), a trial in combination with chemotherapy in previously treated SCLC (NCT02514447), and a trial in combination with chemotherapy in metastatic triple-negative breast cancer (NCT02978716).
About G1 Therapeutics
G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs, trilaciclib, lerociclib and G1T48, that are designed to enable more effective combination treatment strategies and improve patient outcomes across multiple oncology indications.
G1 is based in Research Triangle Park, NC. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the therapeutic potential of trilaciclib, lerociclib and G1T48, and are based on the Company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the Company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the Company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; the Company’s development of a CDK4/6 inhibitor to reduce chemotherapy-induced myelosuppression is novel, unproven and rapidly evolving and may never lead to a marketable product; and market conditions. Except as required by law, the Company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Head of Investor Relations/Public Relations
Source: G1 Therapeutics