Corvus Pharmaceuticals, Inc. has commenced a registrational Phase 3 clinical trial to evaluate soquelitinib for patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). This study marks a significant step forward in addressing the unmet needs of patients with this aggressive malignancy.
The Phase 3 trial (NCT06561048) is a randomized, controlled study designed to assess the efficacy and safety of soquelitinib compared to standard of care chemotherapy. The trial aims to enroll approximately 150 patients with relapsed/refractory PTCL who have failed one to three prior lines of therapy. Participants will be randomized in a 1:1 ratio to receive either a 200mg dose of soquelitinib twice daily or standard chemotherapy with belinostat or pralatrexate.
Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus, stated, "The initiation of the soquelitinib Phase 3 trial for relapsed PTCL is an important milestone for Corvus and for patients suffering with this disease. Soquelitinib has a unique mechanism of action based on selective ITK inhibition, which we believe has potential for the treatment of T cell lymphomas, as well as for solid tumors and a broad range of immune diseases."
Trial Design and Endpoints
The primary endpoint of the clinical trial is progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), and duration of response (DoR). The trial is expected to enroll patients at approximately 40 sites across the United States, Canada, Australia, and South Korea.
Soquelitinib: A Novel ITK Inhibitor
Soquelitinib (formerly CPI-818) is an investigational, oral, small molecule drug designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme predominantly expressed in T cells. ITK plays a crucial role in T cell and natural killer (NK) cell immune function. Preclinical and early clinical data suggest that soquelitinib can modulate T cell differentiation, enhance anti-tumor immune responses, and prevent T cell exhaustion.
Swaminathan P. Iyer, M.D., principal investigator of the study and Professor at The University of Texas MD Anderson Cancer Center, commented, "In earlier stage trials, soquelitinib has been well-tolerated and has demonstrated durable anti-tumor activity in patients with very advanced disease. Soquelitinib’s novel mechanism of action results in enhancement of the host anti-tumor response... There has been a scarcity of new ideas for the treatment of PTCL and we are eager to see if soquelitinib can offer these patients a more effective and safer treatment."
Peripheral T-Cell Lymphoma: An Unmet Need
PTCL represents a heterogeneous group of malignancies, accounting for 10-25% of non-Hodgkin lymphomas (NHL) globally. The most common subtypes include PTCL-not otherwise specified (PTCL-NOS) and T follicular helper cell lymphoma. While initial therapy often involves combination chemotherapy, approximately 75% of patients relapse within two years. Subsequent treatments yield poor outcomes, with median progression-free survival ranging from 3 to 4 months and overall median survival between 6 and 12 months. Currently, there are no approved drugs based on randomized trials for relapsed PTCL, underscoring the urgent need for novel therapeutic options.
Soquelitinib has been granted Orphan Drug Designation and Fast Track Designation by the FDA, highlighting its potential to address this critical unmet need.
