Summary:
GTHX Trilaciclib Phase 3 data in colorectal cancer is expected in February 2023
This is initial PRESERVE 1 CRC data and initial PFS data is expected in Q4 2023
So far no CRC data from Trilaciclib has been reported - Ph2 data was from breast cancer patients
See our BPIQ Pro article with more info on upcoming CRC readouts after signing up. Learn more here.
Trilaciclib
Trilacaclib is a small molecule cylin-dependent kinase (CDK) 4/6 inhibitor that is already approved to treat small cell lung cancer under the name COSELA. Tricaclib is currently in several late stage clinical trials for cancer including colorectal cancer, breast cancer, and bladder cancer. These trials are evaluating trilaciclib in combo with chemotherapy regimens, specifically FOLFOXIRI for the CRC trial.
The Phase 3 PRESERVE 1 trial is evaluating trilaciclib before treatment with FOLFOXIRI and bevacizumab for patients with metastatic colorectal cancer (mCRC). The primary myeloprotection endpoint for this trial is to evaluate severe neutropenia during induction and duration of severe neutropenia, Grade 3 or 4 diarrhea, and patient outcome data.
Currently the doublet therapy of FOLFOXIRI and bevacizumab is the best treatment for 1L CRC patients, but is very myelotoxic and only works for a small population, so the addition of Trilaciclib could work as a myeloprotective agent for these patients.
PRESERVE 1 Data
PRESERVE 1 data in CRC is expected in February!
This will be the initial results from the pivotal Phase 3 trial, and the first Trilaciclib data in CRC. Progression Free Survival (PFS) data is expected in Q4 2023. If data expected next month is positive, COSELA could launch in 2024 for CRC.
Patients in this trial include first line (1L) CRC patients, which includes MSS patients. This is the same type of colorectal cancer that AGEN's Botensilimab is treating. See our previous CRC/ASCO-GI article for more info on the AGEN data presented and what is to come for the company HERE.
The primary endpoint of the PRESERVE 1 trial is myeloprotection to include severe neutropenia during induction & duration of severe neutropenia during Cycles 1-4 of treatment.
Severe neutropenia is characterized as an abnormally low count of neutrophils ( white blood cells), specifically less than 500 / microliter. This often occurs with chemotherapy and can lead to shorter duration of the treatment.
Also being evaluated is the impact of trilaciclib on Grade 3 or 4 diarrhea: Grade 3 typically requires a hospital stay and Grade 4 can be life-threatening.
See more about the upcoming PRESERVE 1 trial in our Pro forum post HERE.
Other CDK4/6 and CRC assets
See Table 1 for CRC events through the first half of the year, and our BPIQ Pro forum for events through the end of 2023! Learn more here about our subscriptions. Coming this year includes readouts from KPTI, RCUS, GRTS, MRTX, and more!
Also in our Pro forum post is a list of other CDK4/6 inhibitors targeting cancers.
Table 1. CRC events through first half 2023
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