G1 Therapeutics' Cosela fails to improve survival in pivotal TNBC study
24 Jun 2024
Phase 3Drug ApprovalClinical ResultClinical Trial TerminationPhase 2
G1 Therapeutics said Monday that the Phase III PRESERVE 2 study evaluating Cosela (trilaciclib) in triple-negative breast cancer (TNBC) failed to meet its primary overall survival (OS) endpoint. CEO Jack Bailey called the results “unexpected,” adding “we are disappointed that this trial did not deliver the benefit that we anticipated.”
However, questions had been raised around the outcome of the study when G1 Therapeutics announced in February that it would continue to its final survival analysis, denting hopes of an early readout. The company had already pushed back an interim OS analysis from the second half of 2023 to the first half of 2024, as "the number of actual events appears to be occurring more slowly than predicted.”
On Monday, G1 Therapeutics noted that median OS in the trilaciclib plus chemotherapy arm was 17.4 months compared to 17.8 months in the control arm, with a hazard ratio (HR) of 0.91. The drugmaker added that median OS numerically favoured the trilaciclib arm in both PD-L1 subgroups, although neither achieved statistical significance.
The trial included 187 patients with locally advanced unresectable or metastatic TNBC who received first-line Cosela or placebo prior to chemotherapy with gemcitabine and carboplatin. Results from the study are expected to be presented at an upcoming medical meeting.
Cosela was first approved by the FDA in 2021 to reduce the frequency of chemotherapy-induced myelosuppression in adults receiving certain types of chemotherapy for extensive-stage small-cell lung cancer. The transient CDK4/6 inhibitor also gained approval in China for the same indication, where it is partnered with Simcere Pharmaceuticals.
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