Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC):

Phase 3 Terminated 326 enrolled G1 Therapeutics, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This was a randomized, double-blind, placebo-controlled, global, multicenter, Phase 3 trial evaluating the impact of trilaciclib on myelopreservation and anti-tumor efficacy when administered prior to FOLFOXIRI/bevacizumab in patients with pMMR/MSS mCRC who have not received systemic therapy for metastatic disease.

Timeline

Start: 2021-01-06
Primary completion: 2023-02-13
Completion: 2023-03-31

Outcome

Met primary endpoint

Stopped: “The Sponsor made the decision to terminate the study and complete the final analysis for available data.”

paper The study met its co-primary endpoints. PMID 39579142 ↗

registry p <0.001; Mean Difference (Final Values) -1.2 (95% CI -1.7 to -0.6); ANCOVA NCT04607668 ↗

registry p <0.001; aRR 0.04 (95% CI 0.01 to 0.19); modified Poisson model NCT04607668 ↗

Publications

Lenz HJ, Liu T, Chen EY, Horvath Z, Bondarenko I, Danielewicz I, Ghidini M, Garcia-Alfonso P, Jones R, Aapro M, Zhang Y, Wang J, Wang W, Adeleye J, Beelen A, Hubbard J. Trilaciclib prior to FOLFOXIRI/bevacizumab for patients with untreated metastatic colorectal cancer: phase 3 PRESERVE 1 trial. JNCI Cancer Spectr. 2025 Jan 3;9(1):pkae116. doi: 10.1093/jncics/pkae116.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trilaciclib	Unknown	—	Intravenous