Enrollment Complete for PRESERVE 1 Trial of Trilaciclib in Metastatic Colorectal Cancer

Enrollment has been completed for the phase 3 PRESERVE 1 trial of trilaciclib in patients with metastatic colorectal cancer receiving chemotherapy.

Patient accrual has been completed for the phase 3 PRESERVE 1 trial (NCT04607668) investigating trilaciclib (Cosela) for patients with metastatic colorectal cancer (mCRC) receiving chemotherapy, according to G1 Therapeutics, Inc.1

A total of 326 patients have been enrolled in the trial, making the study over-enrolled by approximately 10% in order to compensate for potential loss to follow up at trial sites in Ukraine.

“FOLFOXIRI is an important chemotherapeutic backbone for people diagnosed with CRC because it is highly efficacious and has shown a survival advantage compared to other chemotherapeutic options; however, it is also the most myelotoxic regimen, so patients may have dose delays and reductions or receive less effective chemotherapeutic regimens - both of which could impact patient outcome and survival,” said Raj Malik, MD, chief medical officer of G1 Therapeutics, in the press release. “Trilaciclib may be an important addition to this regimen due to its unique ability to preferentially protect the bone marrow from chemotherapy-induced toxicities, and its potential to preserve immune system function and improve survival. Both endpoints are being assessed in PRESERVE 1.”

The randomized, double-blind, placebo-controlled, global, multicenter, phase 3 PRESERVE 1 trial is evaluating trilaciclib and its impact on myelopreservation and anti-tumor efficacy when administered to patients with metastatic mCRC prior treatment with FOLFOXIRI or bevacizumab (Avastin).2

Enrollment in the trial is open to patients aged 18 years of age or older with proficient mismatch repair/microsatellite stable, histologically or cytologically-confirmed adenocarcinoma of the colon or rectum. Patients with any BRAF or KRAS mutation status are eligible, and disease must be unresectable and measurable or have evaluable per RECIST v1.1. Further requirements include an ECOG performance status of 0 to 1 and adequate organ function.

Patients will be randomized in a 1:1 ratio to receive either placebo or trilaciclib intravenously on 2 consecutive days of every 14-day cycle for a maximum of 12 cycles of induction followed by maintenance therapy. Treatment will be administered until disease progression, unacceptable toxicity, withdrawal of consent, discontinuation by Investigator, or the end of the trial.

The primary end point of the trial is myelopreservation from the time of induction to an average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab. Secondary end points include quality of life effects on chemotherapy-induced fatigue and anti-tumor efficacy, effect of trilaciclib on progression free survival, and overall survival compared with placebo.

“We are happy to have completed enrollment, and look forward to presenting initial data, including the primary endpoint of the trial, in the first quarter of 2023. This is a registrational trial; if the data from the primary endpoint are positive, we would work closely with the FDA to expedite our filing for regulatory approval in this indication,” added Malik, in the press release.

  1. G1 therapeutics announces completion of enrollment in global multi-center phase 3 clinical trial of trilaciclib in patients with metastatic colorectal cancer. News release. G1 Therapeutics, Inc. June 13, 2022. Accessed June 17, 2022. https://bit.ly/3b9yhv6
  2. Trilaciclib, a CDK 4/6 inhibitor, in patients receiving FOLFOXIRI/bevacizumab for metastatic colorectal cancer (mCRC): (PRESERVE1). ClinicalTrials.gov. Accessed June 17, 2022. https://clinicaltrials.gov/ct2/show/NCT04607668