New data analyses demonstrate multi-lineage benefits of trilaciclib on neutrophils, red blood cells and lymphocytes in treatment of first-line small cell lung cancer

RESEARCH TRIANGLE PARK, N.C., Oct. 09, 2018 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that new data from its randomized Phase 2 clinical trial of trilaciclib in combination with etoposide/carboplatin for treatment of first-line small cell lung cancer (SCLC) will be presented at the European Society for Medical Oncology (ESMO) 2018 Congress, being held in Munich, Germany. The company reported topline data from this trial in March 2018 showing robust myelopreservation benefits. Additional data from this trial have been selected for a poster discussion session on October 21. A second poster with new data focused specifically on the impact of trilaciclib on immune system function, including preservation of T cell subsets such as activated CD8+ T cells and an increased CD8+/regulatory T cell ratio in peripheral blood compared to placebo, will be presented on October 20.

"These Phase 2 trial data are consistent with previously reported topline findings and demonstrate the multi-lineage myelopreservation benefits of trilaciclib across neutrophils, red blood cells and lymphocytes for patients receiving chemotherapy," said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. "Our analyses of trilaciclib-related immune response supports the hypothesis that trilaciclib has the potential to improve efficacy of chemotherapy/immune checkpoint inhibitor combinations. Chemotherapy/checkpoint combinations are emerging as standard of care in multiple tumor types, and trilaciclib may offer both myelopreservation and survival benefits when added to these regimens. We expect preliminary myelopreservation data from our Phase 2 clinical trial combining trilaciclib with chemotherapy and the checkpoint inhibitor Tecentriq^® (atezolizumab) for the treatment of first-line small cell lung cancer later this year."

Details on the presentations are listed below. Both presentations will be available on the Publications page of the company’s website following their presentation at ESMO.

Title: Trilaciclib (trila) preserves and enhances immune system function in extensive-stage small cell lung cancer (ES-SCLC) patients receiving first-line chemotherapy
Presentation Number: 1671P
Session Name: Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research
Date / Time / Location: October 20, 12:50 p.m. CEST/6:50 a.m. ET, Hall A3 - Poster Area Networking Hub, ICM München
Presenter: Jessica A. Sorrentino, Ph.D. (G1 Therapeutics)

Title: Trilaciclib decreases multi-lineage myelosuppression in extensive-stage small cell lung cancer (ES-SCLC) patients receiving first-line chemotherapy
Presentation Number: 1666PD
Session Name: Poster discussion session - Non-metastatic NSCLC and other thoracic malignancies
Date / Time / Location: October 21, 3:25 p.m. CEST/9:25 a.m. ET, ICM – Room 1, ICM München
Presenter: Konstantin H. Dragnev, M.D. (Norris Cotton Cancer Center, Dartmouth-Hitchcock)

For more information about the ESMO 2018 congress, please visit https://www.esmo.org/Conferences/ESMO-2018-Congress/

About Trilaciclib
Trilaciclib is a first-in-class myelopreservation therapy designed to preserve hematopoietic stem and progenitor cell function, as well as 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 will be reported at the European Society for Medical Oncology (ESMO) 2018 Congress being held October 19-23. 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 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.

Forward-Looking Statements
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 press release include, but are not limited to, the therapeutic potential of trilaciclib, lerociclib and G1T48, and are based on G1 Therapeutics’ 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 G1 Therapeutics’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in G1 Therapeutics’ filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, G1 Therapeutics’ ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the inherent uncertainties associated with developing new products or technologies and operating as a clinical-stage company; G1 Therapeutics’ initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; G1 Therapeutics’ 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, G1 Therapeutics assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:

Jeff Macdonald
Head of Investor and Public Relations
919-213-9835
jmacdonald@g1therapeutics.com

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