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Corvus Pharmaceuticals Confirms Planned Initiation of Soquelitinib (CPI-818) Phase 3 Registrational Clinical Trial in Peripheral T Cell Lymphoma Following Meeting with FDA
Plans to initiate soquelitinib potentially registrational Phase 3 clinical trial in Q1 2024 Company to host conference call and webcast tomorrow at 8:30 a.m.
About this update from Corvus Pharmaceuticals, Inc.
[{"type":"text","content":"Plans to initiate soquelitinib potentially registrational Phase 3 clinical trial in Q1 2024 Company to host conference call and webcast tomorrow at 8:30 a.m. ET / 5:30 a.m. PT BURLINGAME, Calif., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, confirmed today 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). “We are pleased with the outcome of our End-of-Phase/Pre-Phase 3 meeting with FDA, allowing us to advance ITK inhibition with soquelitinib into a potentially registrational clinical trial for patients with relapsed peripheral T cell lymphoma,” said Richard A. Miller, co-founder, president and chief executive officer of Corvus. “We appreciate the FDA’s input and their confirmation on the key aspects of the trial design, including sample size, dosing, eligibility, comparator arm and endpoints. We are now focused on finalizing the study protocol, qualifying trial sites and completing other standard steps required to initiate the trial. Based on current timelines, we anticipate that we can initiate the trial in the first quarter of 2024.” 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. Dr. Miller added, “Soquelitinib’s proposed mechanism of action, based on selective ITK inhibition, represents a platform opportunity with the potential to address a wide range of indications beyond hematologic cancers, including solid tumors ...