On March 20, 2025 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, reported that additional data from the Company’s Phase 1/1b clinical trial of soquelitinib for the treatment of patients with T cell lymphoma (TCL) is being presented at the 16th Annual T-Cell Lymphoma Forum taking place March 20-22, 2025 in San Diego, CA (Press release, Corvus Pharmaceuticals, MAR 20, 2025, View Source [SID1234651319]).
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"The data from the Phase 1/1b clinical trial of soquelitinib in patients with T cell lymphoma continues to demonstrate strong indications of anti-tumor activity in a significant number of patients," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We are encouraged by the high complete response, prolonged median progression free survival and high rate of 18-month progression free survival, which all appear superior to standard of care agents such as belinostat and pralatrexate. In addition, analysis of patient blood samples at baseline and on treatment show that soquelitinib reduces T cell exhaustion, which may allow for improved T cell function and anti-tumor immunity. Supported by this data, our registrational Phase 3 trial of soquelitinib is enrolling patients with relapsed peripheral T cell lymphoma at multiple sites in the U.S., Canada and Australia, along with our Phase 1 trial in atopic dermatitis that is anticipated to deliver data in the second quarter 2025."
The soquelitinib data from the Phase 1/1b clinical trial of soquelitinib for TCL will be presented by John Reneau, MD, PhD, Assistant Professor in the College of Medicine and The Ohio State University Comprehensive Cancer Center. Dr. Reneau is a hematologist who specializes in treating patients with lymphoma and an investigator in the trial. The details of Dr. Reneau’s presentations are as follows:
Oral Presentation
Title: Selective ITK Inhibition for Treatment of PTCL
Time: 4:50 – 5:10 pm PT on March 20, 2025
Poster Presentation
Abstract Title: Soquelitinib, a Selective ITK Inhibitor for Treatment of T Cell Lymphomas: Results of Ph1 trial Reveal Novel Mechanisms of Action
Soquelitinib Phase 1/1b Overview and Key Data
A total of 25 patients were enrolled in the Phase 1/1b trial at the optimum 200 mg two-times a day dose and would have met the eligibility criteria for the ongoing registrational Phase 3 clinical trial based on ≥1 and ≤3 prior therapies, including 23 evaluable patients. For the 23 evaluable patients:
Objective responses (complete response, CR, plus partial response, PR) were seen in nine patients (39%), including six CRs (26%) and three PRs.
The median duration of response (DOR) for the nine patients with objective response by Lugano criteria was 17.2 months.
Three patients continue on therapy at 25+ months, 18+ months and 14+ months.
Kaplan Meier estimated median progression free survival (PFS) was 6.2 months.
At 18-month follow-up, the PFS rate was 30%, which compares favorably to 18-month PFS of <20% with belinostat or pralatrexate.1 2
Peripheral blood samples were collected from patients both prior to the initiation of soquelitinib therapy and during the course of treatment. These samples were analyzed for markers of T cell exhaustion in normal T cells. The results indicated that the majority of patients exhibited a reduction in T cell exhaustion markers on both CD4+ and CD8+ cells after 21 days of treatment. T cell exhaustion is a state in which T cells exhibit diminished functionality due to prolonged exposure to antigens.
Soquelitinib was well-tolerated, with no new safety signals, drug interruptions or dose reductions.
Based on the results from the Phase 1/1b trial, Corvus is enrolling patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed Peripheral T cell lymphoma (PTCL) at multiple sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate. The primary endpoint of the trial is PFS. There are no FDA fully approved agents for the treatment of relapsed 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.
About Peripheral T Cell Lymphoma
Peripheral T cell lymphoma (PTCL) is a heterogeneous group of malignancies accounting for about 10% of non-Hodgkin’s lymphomas (NHL) in western populations, reaching 20% to 25% of NHL in some parts of Asia and South America. The most common subtypes are PTCL-not otherwise specified (PTCL-NOS) and T follicular helper cell lymphoma. Initial therapy for these diseases is typically combination chemotherapy; however, approximately 75% of patients either do not respond or relapse within the first two years. Patients in relapse are treated with various chemotherapy agents but have poor overall outcomes with median progression-free survival in the 3 to 4 month range and overall median survival of 6 to 12 months. There are no approved drugs in relapsed PTCL based on randomized trials.
PTCL is a disease of mature helper T cells that express ITK (interleukin-2-inducible T cell kinase), often containing numerous genetic mutations and frequently associated with viral infection. Most often the malignant cells of PTCL express a Th2 phenotype.
About Soquelitinib
Soquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. Soquelitinib has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases. Recent studies have demonstrated that ITK controls a switch between the differentiation of Th17 proinflammatory cells and T regulatory suppressor cells. Inhibition of ITK leads to a shift toward T regulatory cell differentiation which has the potential to suppress autoimmune and inflammatory reactions. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company is conducting a registrational Phase 3 clinical trial (NCT06561048) of soquelitinib in patients with relapsed PTCL. Soquelitinib is also being investigated in a randomized placebo-controlled Phase 1 clinical trial in patients with atopic dermatitis and a Phase 2 clinical trial in patients with autoimmune lymphoproliferative syndrome (ALPS), a rare genetic disease. A recent publication describing the chemistry, enzymology and biology of soquelitinib appeared in NPJ Drug Discovery in December 2024 and is available online at the Nature website and on the Publications and Presentations page of the Corvus website.