G1 discontinues pivotal colorectal cancer trial due to adverse survival signals


G1 Therapeutics’ approach to cancer is not tumor-killing. Instead, the biotechnological drug trilaciclib protects the bone marrow from the harmful effects of chemotherapy, reducing the duration and severity of problems that may limit the use of this cancer treatment. Since the first approval of trilaciclib
G1 has furthered clinical trials that could support expansion of the drug to other cancers. Colorectal cancer is no longer one of them.

Monday, G1 Preliminary data reported The placebo group has been shown to be superior to the trilaciclib group in helping patients live longer. G1 said it had decided to stop its colorectal cancer trial.The Research Triangle Park, N.C.-based company added that an independent data oversight board had independently reached the same conclusion. rice field.

The Phase III trial enrolled 325 patients with metastatic colorectal cancer. Intravenous trilaciclib is given before chemotherapy to provide its protective effect. Study participants were randomly assigned to receive the G1 drug or placebo. He then received chemotherapy and Avastin, a Roche drug approved for second-line treatment of colorectal cancer. This regimen took him on two consecutive days for each 14-day treatment cycle. Patients received up to 12 cycles followed by maintenance therapy.

G1 showed that the trilaciclib group achieved its primary goal of reducing severe neutropenia, an abnormally low level of white blood cells called neutrophils. In comparison, it also led to a clinically meaningful reduction in chemotherapy-induced diarrhea.

But the company also said early efficacy data, including overall response rates and preliminary measures of how long patients lived while on treatment, supported the placebo arm. Adverse survival signals have not been reported in previous trials of the drug in small cell lung cancer and triple-negative breast cancer. G1 said details of the Phase III results in colorectal cancer will be presented at an upcoming scientific meeting and submitted for publication.

“Everyone in G1 is disappointed with this amazing result. [colorectal cancer]but we continue to work on the potential of trilaciclib to impact the lives of many cancer patients in other indications. We look forward to future results from other ongoing trials.”

Trilaciclib Receives Approval for Small Cell Lung Cancer in 2021G1 markets the drug under the name ‘Cosella’. Last year, through the third quarter, he had $22.5 million in sales. The company hopes to obtain additional approvals for other indications as a way to grow its revenue. G1 said the Phase 3 trial in triple-negative breast cancer is expected to report first data in the second half of 2023. Enrollment of a Phase 2 trial of trilaciclib in bladder cancer has been completed.

image by National Cancer Institute

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