G1 Therapeutics to Present Clinical Data on Trilaciclib and Rintodestrant at 2020 San Antonio Breast Cancer Symposium (SABCS)
G1 Therapeutics (GTHX) announced promising final overall survival data from its Phase 2 trial for trilaciclib in metastatic triple-negative breast cancer (mTNBC), demonstrating a significant median overall survival benefit when combined with gemcitabine/carboplatin chemotherapy. The results will be presented at the 2020 San Antonio Breast Cancer Symposium on December 9. Additionally, updated findings on rintodestrant, a potential oral selective estrogen receptor degrader, will also be shared. The company anticipates a pivotal trial for trilaciclib to commence in 2021.
- Final overall survival data from Phase 2 trial shows significant improvement with trilaciclib.
- Data will be presented at the prestigious 2020 San Antonio Breast Cancer Symposium.
- Plans to initiate a pivotal trial for trilaciclib in 2021, focusing on overall survival as the primary endpoint.
- None.
RESEARCH TRIANGLE PARK, N.C., Nov. 18, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that final overall survival (OS) data from its randomized Phase 2 trial of trilaciclib in metastatic triple-negative breast cancer (mTNBC) were consistent with preliminary findings announced last year, and showed that trilaciclib significantly improved median OS for patients treated with trilaciclib in combination with a chemotherapy regimen of gemcitabine/carboplatin. These data will be presented in a Spotlight Poster Session at the 2020 San Antonio Breast Cancer Symposium (SABCS) on Wednesday, December 9. Trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy.
The company will also present updated monotherapy findings from the Phase 1 portion of its ongoing clinical trial of rintodestrant, a potential best-in-class oral selective estrogen receptor degrader (SERD) in development for treatment of ER+, HER2- breast cancer.
“The findings in the triple-negative breast cancer trial support our strategy to continue to evaluate the potential of trilaciclib to enhance the anti-tumor efficacy of chemotherapy,” said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. “We expect to initiate a pivotal trial of trilaciclib in metastatic TNBC in 2021 with overall survival as the primary endpoint, and will provide additional details on the trial during the 2020 SABCS.”
Information on G1 presentations at 2020 SABCS follows below; additional details are available on the SABCS website.
Title: Trilaciclib improves overall survival when given with gemcitabine/carboplatin in patients with metastatic triple-negative breast cancer: final analysis of a randomized Phase 2 trial
Presenter: Joyce O’Shaughnessy, M.D., Baylor University Medical Center
Poster #PD1-06:Spotlight Poster Discussion 1
Date/time: Wednesday, December 9, 2020; 4:00–5:15 p.m. CT
Title: Rintodestrant (G1T48), an oral selective estrogen receptor degrader, in ER+/HER2- locally advanced or metastatic breast cancer: updated Phase 1 results and dose selection
Presenter: Philippe Aftimos, M.D., Institut Jules Bordet, Université Libre de Bruxelles
Poster #PS12-04: Poster Session 12
Date/time: Wednesday, December 9, 2020; 8:00 a.m. CT
Title: Pharmacodynamic analysis from a Phase 1 study of rintodestrant (G1T48), an oral selective estrogen receptor degrader, in ER+/HER2– locally advanced or metastatic breast cancer
Presenter: Philippe Aftimos, M.D., Institut Jules Bordet, Université Libre de Bruxelles
Poster #PD8-07: Spotlight Poster Discussion 8
Date/time: Thursday, December 10, 2020; 2:15–3:30 p.m. CT
Title: Population pharmacokinetic and exposure-response modeling of the oral selective estrogen receptor degrader rintodestrant (G1T48) in patients with ER+/HER2– advanced breast cancer
Presenter: Chao Li, Ph.D., G1 Therapeutics, Inc.
Poster #PS17-08: Poster Session 17
Time/date: Wednesday, December 9, 2020; 8:00 a.m. CT
About G1 Therapeutics
G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of next generation therapies that improve the lives of those affected by cancer. The company is developing and advancing two novel therapies: trilaciclib is a first-in-class therapy designed to improve outcomes for patients being treated with chemotherapy; rintodestrant is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. In 2020, the company out-licensed global development and commercialization rights to its differentiated oral CDK4/6 inhibitor, lerociclib.
G1 Therapeutics is based in Research Triangle Park, N.C. 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, those relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, the timing of marketing applications in the U.S. and Europe for trilaciclib in SCLC, trilaciclib’s possibility to improve patient outcomes across multiple indications, rintodestrant’s potential to be best-in-class oral SERD, lerociclib’s differentiated safety and tolerability profile over other marketed CDK4/6 inhibitors, our reliance on partners to develop and commercial licensed products, and the impact of pandemics such as COVID-19 (coronavirus), 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; 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.
Contact:
Jeff Macdonald
G1 Therapeutics, Inc.
Senior Director, Investor Relations & Corporate Communications
919-907-1944
jmacdonald@g1therapeutics.com
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