Corvus Pharmaceuticals, Inc. announced that it completed an End-of-Phase/Pre-Phase 3 meeting with FDA on its plans to initiate a Phase 3 registrational clinical trial of soquelitinib (formerly CPI-818), the Company's ITK inhibitor product candidate, in relapsed peripheral T cell lymphoma (PTCL). The soquelitinib Phase 3 potentially registrational clinical trial is designed to enroll a total of 150 patients with relapsed PTCL that have received three or fewer prior therapies. Patients will be randomized 1:1 to soquelitinib 200 mg two-times a day or standard of care chemotherapy.

The primary endpoint will be progression-free survival. Secondary endpoints will include objective response rate and overall survival. The Company is recruiting U.S. and international investigators and anticipates that leading academic and private medical centers with significant experience in lymphoma research will participate in the trial, including a principal investigator who has conducted other Phase 3 clinical trials in T cell lymphoma and authored many peer-reviewed articles on lymphomas.