G1 Therapeutics forced to plough on with trilaciclib trial

US oncology company G1 Therapeutics (Nasdaq: GTHX) was hoping for a positive interim analysis in its pivotal Phase III of trilaciclib alongside gemcitabine and carboplatin for the first-line treatment of metastatic triple negative breast cancer (mTNBC).

But this has not materialized, with the independent Data Monitoring Committee (DMC) recommending continuation of PRESERVE 2 up until the final analysis evaluating overall survival (OS). This is not expected until the third quarter of 2024 and will be conducted on the intent-to-treat (ITT) population.

"We remain confident in the ability of trilaciclib to ultimately achieve the OS primary endpoint based on the robust survival benefit demonstrated in the prior randomized Phase II study"The DMC did not express any concerns regarding safety or recommend any other changes to the study. G1 remains blinded to all data, and only knows that the early stopping criteria were not met during the interim analysis.