Corvus presents final data from soquelitinib Phase 1/1b T cell lymphoma trial

Corvus Pharmaceuticals (CRVS) announced the presentation of final data from its Phase 1/1b trial of soquelitinib in patients with T cell lymphoma today in an oral session at the 67th American Society of Hematology Annual Meeting & Exposition, which is taking place December 6-9, 2025 in Orlando, FL. The presentation highlights preclinical and clinical data supporting the development of soquelitinib in oncology and immune and inflammatory diseases, including data detailing its mechanism of action. The trial enrolled 75 patients with various T cell lymphomas, including peripheral T cell lymphoma, T follicular helper cell lymphoma, natural killer cell T cell lymphoma, cutaneous T cell lymphoma, anaplastic large cell lymphoma and adult T cell lymphoma/leukemia. The median number of prior therapies was 3, with only 31% achieving an objective response to their most recent prior therapy. In the dose escalation portion, patients received a twice-daily dose of soquelitinib of 100 mg, 200 mg, 400 mg or 600 mg, and the 200 mg twice-daily dose was selected for the dose expansion portion based on biomarker studies indicating that doses of 200mg or higher achieved complete occupancy of the ITK target with the drug. Key highlights from the data supporting the ongoing registration Phase 3 trial in relapsed/refractory PTCL include: No dose limiting toxicities or significant adverse events were observed in any patients in all dose cohorts up to 600 mg twice-daily, including no myelosuppression or immunosuppression; Objective and durable tumor responses were seen in the 200 mg twice-daily cohort with 6 patients experiencing complete responses ; In the 200 mg twice-daily cohort, it was determined that patients with between greater than or equal to1 and less than or equal to3 prior therapies and an adequate peripheral blood lymphocyte count were most likely to be responders to therapy. In this patient population: Objective responses were seen in 9 of 24 patients including 6 complete responses and 3 partial responses; Median progression free survival was 6.2 months, including an 18-month PFS of 30%; Median overall survival was 28.1 months, including a 24-month OS of 67%. Key highlights from the data supporting soquelitinib’s mechanism of action and use in immune and inflammatory diseases include: In vitro studies demonstrated that at appropriate doses, soquelitinib produces Th1 skewing, which is an immunologic property resulting from the blockade of Th2 differentiation and a shift to Th1; Biomarker studies evaluating blood samples and tumor biopsies showed an increase in Th1 in blood and tumor samples and a reduction in serum IL-5, consistent with inhibiting Th2 and Th17 cells. For 6 patients, paired tumor biopsies were compared at baseline and day 8 and showed an increase in intratumor Th1 cells with treatment analyzed using RNA sequencing.