CPI-818 is an experimental oral therapy being developed by Corvus Pharmaceuticals to treat T-cell lymphoma.

How does CPI-818 work?

T-cell lymphoma cancer, which affects a type of immune cell called T-cells, can begin in the lymph nodes or spleen, but the cancerous cells often spread to other tissues.

CPI-818 contains a small molecule that inhibits an enzyme called interleukin-2-inducible T-cell kinase (ITK), an important part of the signaling that occurs within T-cells. ITK stimulates the growth, expansion, and activation of T-cells in times of immune response to threats such as infections.

In T-cell lymphomas, ITK signaling is overactive and contributes to the uncontrolled growth of cancer cells. By blocking this signaling pathway, CPI-818 may be able to slow the growth and spread of the cancer cells and modulate immune responses.

CPI-818 in clinical trials

A Phase 1/1b clinical trial (NCT03952078) is currently recruiting 151 patients with T-cell lymphoma in the U.S., Australia, and Korea to study the safety, tolerability, and anti-tumor activity of CPI-818. In the first half of the trial, patients will be given CPI-818 twice a day at an assigned dose until their disease progresses, or they reach complete remission lasting longer than two months. Each following group of patients will receive a higher dosage of the therapy until a maximum tolerated dose is established. In the expansion phase of the trial, all patients will receive the established dose from the dose-escalation portion of the trial until disease progression or remission lasting longer than two months.

The preliminary results from the first four dosage groups (100 mg, 200 mg, 400 mg, or 600 mg of CPI-818 twice per day) were presented at the T-cell lymphoma forum held at the end of January 2020. They showed that no severe adverse events or dose-limiting toxicities have occurred in the 16 patients who were analyzed.

A total of 11 patients from the first dosage groups are still in therapy. One patient with cutaneous T-cell lymphoma treated with 200 mg of CPI-818 achieved a reduction in lymph node size, and improvements were visible by PET scan imaging (where patients are treated with a tracer that shows areas of high chemical activity, as seen in cancer cells). Another patient treated with the 400 mg dose of the treatment has also shown improvements. Both patients are still continuing on the treatment.

The trial is expected to be completed in December 2022.


Last updated: Feb. 4, 2020


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