|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.
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