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G1 Therapeutics and AstraZeneca Enter Clinical Trial Collaboration in Non-Small Cell Lung Cancer
Under the terms of the agreement, G1 will sponsor and conduct a Phase 1b/2 study in collaboration with
“CDK4/6 inhibitors can enhance the efficacy of targeted therapies, and G1T38 has already shown encouraging preclinical and initial clinical data that support a potential best-in-class profile,” said Mark Velleca, MD, PhD, Chief Executive Officer of G1 Therapeutics. “The addition of G1T38 to Tagrisso in EGFR mutation-positive non-small cell lung cancer has the potential to prolong the time to disease progression by overcoming resistance mechanisms. We look forward to collaborating with
“Tagrisso’s potential as a new first-line treatment of EGFR mutation-positive NSCLC has been shown in a global Phase 3 clinical trial earlier this year,” said
The financial terms of the non-exclusive collaboration have not been disclosed.
Tagrisso (osimertinib) is a third-generation, irreversible EGFR TKI designed to inhibit both EGFR-sensitizing and EGFR T790M-resistance mutations, with clinical activity against central nervous system (CNS) metastases. Tagrisso 40mg and 80mg once-daily oral tablets have been approved in more than 60 countries, including the U.S., EU,
G1T38 is a potential best-in-class oral CDK4/6 inhibitor being developed for use in combination with other targeted therapies in multiple oncology indications. G1T38 was well-tolerated with no grade 3/4 adverse events in a Phase 1 study of 75 healthy subjects. G1T38 is currently being evaluated in combination with Faslodex® in a Phase 1b/2a study in patients with estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer (NCT02983071). Preliminary Phase 1b data from the breast cancer study are expected to be presented at a medical meeting in the second quarter of 2018.
For more information, please visit www.astrazeneca.com and follow us on Twitter @
About G1 Therapeutics
G1 is based in Research Triangle Park, N.C. For more 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, G1T38 and G1T48, and the timing for initiation of additional trials of, patient enrollment in, and data readouts regarding, G1 Therapeutics’ product candidates, 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, the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; G1’s ability to complete clinical trials for, obtain approvals for, and commercialize any of its product candidates; G1’s ability to recruit and enroll patients in our studies; competition in the industry in which we operate; 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.