Lymphoma is a type of cancer that involves the lymphatic system, of which T-cell lymphoma is one of the types. Targeting T-cell lymphoma has been one of the focuses of the medical community, however, there are not many effective methods. Recently, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to soquelitinib (formerly CPI-818) as a potential option for T-cell lymphoma**. This news was provided by Corvus Pharmaceuticals, IncAnnounce.
Soquelitinib is an oral, investigational small molecule drug designed to selectively inhibit interleukin-2 inducible T cell kinase (ITK) expressed in T cells. ITK plays a role in T cell and natural killer cell immune function.
Interim data from a Phase 1 1b trial (NCT03952078) presented at the 2022 ASH Annual Meeting showed that soquelitinib showed tumor response in patients with advanced, refractory T-cell lymphoma. In 11 patients with refractory T-cell malignancies, soquelitinib was treated at a dose of 200 mg twice daily and achieved one complete response (CR with lymph node CR and two with partial response. Soquelitinib was well tolerated at doses up to 600 mg twice daily, and no dose-limiting toxicities were observed.
According to the FDA and Corvus Pharmaceuticals, IncThe end of one of the pre-Phase 3 meetings confirmed that a Phase 3 clinical trial of ITK inhibitors in ** peripheral T-cell lymphoma (PTCL) is planned to begin in the second quarter of 2024.
richard a."Peripheral T-cell lymphoma is an aggressive subtype of non-Hodgkin lymphoma that typically has a poor prognosis," Miller, MD, Co-Founder, President and CEO of Corvus Inc. said in a press release. "For these patients, there is a great need for new drugs because existing drugs have limited efficacy and are associated with significant toxicity. ”
Mechanistic studies of soquelitinib have shown that it has the potential to regulate normal T helper cell differentiation. By promoting the production of cytokines that cytotoxic killer T cells and inhibiting cancer cell survival, soquelitinib may enhance anti-tumor immune activity. In addition, soquelitinib has also been shown to prevent T cell depletion, which is a current limitation of many immune** and CAR-T cells**.
The planned phase 3 trial of soquelitinib is designed to enroll 150 patients with ** PTCL who have received up to three prior ** regimens. Patients will be randomized 1:1 to receive either soquelitinib (200 mg dose) or standard chemotherapy.
The primary endpoint of the study will be progression-free survival, and key secondary endpoints will include objective response rate and overall survival.
In a press release, Miller added, "There are currently no FDA-approved agents for sexual PTCL. "Orphan drug designation is an important milestone in the development of soquelitinib and highlights the unmet need of patients with T-cell lymphoma. ”
Overall, soquelitinib has demonstrated its potential in clinical trials as a potential drug for T-cell lymphoma**. The FDA's orphan drug designation supports the development and further research of soquelitinib. With further clinical trials and studies, we hope that soquelitinib will bring a new ** option to T-cell lymphoma patients, improving their prognosis and quality of life."