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ARTICLE | Clinical News

Phase II data for G1’s trilaciclib raises questions about its uptake potential in TNBC

September 30, 2019 10:33 PM UTC

G1 showed trilaciclib led to a significant reduction in the risk of death for metastatic triple-negative breast cancer, but a shifting treatment landscape that includes checkpoint inhibitors could mean an uncertain commercial and regulatory path as the biotech plans its Phase III trial. Investors trimmed $419.9 million off of G1’s market cap as they digested the results.

In a controlled, open-label Phase II study of trilaciclib plus chemotherapy, the small molecule IV formulation of a CKD4/CDK6 inhibitor reduced the risk of death by 64% across the two different dose regimens. In 33 patients who were given trilaciclib plus chemotherapy on the same day, the median overall survival was 20.1 months (HR: 0.33; p=0.028) vs. 17.8 months (HR:0.34; p=0.0023) for 35 patients dosed with trilaciclib the day before and on the same day as chemotherapy. OS is a secondary endpoint in the trial...

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G1 Therapeutics Inc.