RESEARCH TRIANGLE PARK – G1 Therapeutics,which is focused on oncology research, will no longer seek to explore one of its drug candidates as a treatment for colorectal cancer, the company announced Monday.
The “pivotal” Phase 3 clinical trial of trilaciclib showed “that the trial achieved its co-primary endpoints related to severe neutropenia with statistical significance; however, early anti-tumor efficacy data, including overall response rate (ORR) and preliminary measures of survival, favored the placebo arm,” G1 explained.
The company will continue to test trilaciclib in other treatment trials, however.
Raj Malik, M.D., G1 Therapeutics’ chief medical officer, noted: “This study reaffirms that trilaciclib is a highly effective drug for myeloprotection [mitigates against chemotherapy damage] that all but eliminated neutropenia as a concern for patients with CRC in the trial, which helps inform our ongoing combination studies with other highly myelotoxic regimens like ADCs. Unfortunately, despite the robust myeloprotection and improved tolerability, early survival indicators, including the observed overall response rate in this trial, favor patients receiving placebo.”
CEO Jack Bailey concurred.
“All of us at G1 are disappointed in this surprising outcome for patients with CRC, but we remain committed to the potential of trilaciclib to impact the lives of many cancer patients in other indications,” he said. “We are increasingly encouraged by the real-world performance of trilaciclib in patients with extensive stage small cell lung cancer and look forward to upcoming readouts in our other ongoing trials.”
