On December 8, 2025 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, reported the presentation of final data from its Phase 1/1b trial of soquelitinib in patients with T cell lymphoma in an oral session at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) 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.
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"The T-cell lymphomas are devastating diseases, associated with dismal outcomes, and are thus an area of high unmet need," said Ryan Wilcox, M.D., Ph.D., Associate Professor of Internal Medicine, University of Michigan Medical School. "In the relapsed/refractory setting, complete and durable responses are rarely achieved with currently available agents. The Phase 1 data demonstrate impressive progression free and overall survival in relapsed/refractory patients treated with soquelitinib. Several patients experienced complete and durable responses, some of which were maintained on therapy more than two years. For most relapsed/refractory PTCL patients, an overall survival less than 6 months is anticipated. In the phase 1 study, median progression free survival was 6.2 months and median overall survival exceeded 2 years. These results provide the foundation for the ongoing registration Phase 3 trial in relapsed/refractory peripheral T cell lymphoma."
The trial enrolled 75 patients (27 in dose escalation portion and 48 in dose expansion portion) with various T cell lymphomas, including peripheral T cell lymphoma (PTCL), T follicular helper cell lymphoma (TFHC), natural killer cell T cell lymphoma (NKTCL), cutaneous T cell lymphoma (CTCL), anaplastic large cell lymphoma (ALCL) and adult T cell lymphoma/leukemia (ATLL). The median number of prior therapies was 3 (range 1-18), 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 (N=36) with 6 patients experiencing complete responses
In the 200 mg twice-daily cohort, it was determined that patients with between ≥1 and ≤3 prior therapies and an adequate peripheral blood lymphocyte count (N=24) 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 (PFS) was 6.2 months, including an 18-month PFS of 30%
Median overall survival (OS) was 28.1 months, including a 24-month OS of 67%
Key highlights from the data supporting soquelitinib’s mechanism of action (Th1 skewing and blocking Th2 and Th17 differentiation) 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
"The data presented at ASH (Free ASH Whitepaper) provides foundational information for the future development of soquelitinib and our ITK platform across oncology, immune disease and inflammation," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "In oncology, the data show that soquelitinib could be a new treatment option for T cell lymphomas, including in patients with advanced, aggressive disease. The data not only support our ongoing registration Phase 3 trial in PTCL, but also show immunobiological effects that demonstrate soquelitinib’s mechanism of action of affecting T cell differentiation via ITK inhibition. The mechanism operates upstream in T cell signaling pathways, which may indicate that resistance pathways are unlikely to evolve."
Dr. Miller added, "Outside of oncology, we are focused on the development of soquelitinib in atopic dermatitis and evaluating its potential in a broad range of immune and inflammatory diseases. We plan to present additional data from extension cohort 4 of our Phase 1 atopic dermatitis trial in January and initiate a Phase 2 trial in this indication in early Q1 2026."
Corvus is currently enrolling patients in a registration Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed/refractory PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate. The primary endpoint of the trial is progression free survival. There are no FDA fully approved agents for the treatment of relapsed/refractory PTCL, and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least 2 lines of systemic therapy. The Company anticipates reporting interim data from the Phase 3 trial in late 2026 and completing the trial in 2027.
The ASH (Free ASH Whitepaper) oral presentation slides are available on the Publications and Presentations page of the Corvus website.
(Press release, Corvus Pharmaceuticals, DEC 8, 2025, View Source [SID1234661275])